Press Releases

PLYMOUTH MEETING, PA, March 6, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's management team will participate in the following upcoming investor conferences...

The annual funding programs support initiatives that support patient-centric initiatives within rare neurological disease and sleep disorder communities

Applications for Patients at the Heart and Progress at the Heart open today, Tuesday, February 28, timed to “Rare Disease Day”

PLYMOUTH MEETING, PA, February 28, 2023 — Community and nonprofit organizations throughout the country that are working to support patient-centric initiatives within rare neurological diseases and sleep disorders will have the opportunity to receive funding to support innovative initiatives, thanks to the continuation of Harmony Biosciences’ Patients at the Heart and Progress at the Heart programs. Harmony Biosciences (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, launched the programs in 2019 and 2021, respectively, and today announced the reopening of the application period for 2023.

Both the Patients at the Heart and Progress at the Heart funding programs provide opportunities for organizations providing innovative, comprehensive, and patient-centric initiatives that either directly support the unique challenges and profound needs of people living with sleep disorders and rare neurological diseases who experience excessive daytime sleepiness (EDS) or help achieve greater equality within rare neurological disease communities.

WAKIX® (pitolisant) Net Revenue Increased ~41% Year-over-Year to $128.3 Million for Fourth Quarter 2022; ~43% to $437.9 Million for Full Year 2022

Achieved Net Income of $181.5 Million for Full Year 2022

Average Number of Patients on WAKIX Increased to ~4,900

Continued Strong Momentum in Phase 3 Idiopathic Hypersomnia (“IH”) INTUNE Study

Conference Call and Webcast to be Held Today at 8:30 a.m. ET

PLYMOUTH MEETING, PA, February 21, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today reported financial results and business updates for the fourth quarter and full year ended December 31, 2022.

“We delivered another strong quarter in Q4, finishing the year with continued momentum in both our commercial business for WAKIX and in our clinical development programs for pitolisant,” stated Jeffrey M. Dayno, M.D., interim chief executive officer and chief medical officer of Harmony.

“Looking ahead, we remain confident in the ongoing performance of WAKIX. Harmony remains a growth story, with the focus on advancement of our life cycle management programs for pitolisant and acquisition of new assets to build out our pipeline to drive additional growth. With that as our focus, I am excited to lead the company forward.”

Recognition reinforces strong company culture and employee experience

PLYMOUTH MEETING, PA, February 17, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for people with rare neurological diseases, today announced the company has earned the Great Place to Work® recognition for the fifth year in a row. The distinction was awarded to Harmony Biosciences based on survey feedback from Harmony employees that verified the quality of the company’s culture and their employee experience.

“Earning the Great Place to Work® certification again this year underscores our ongoing commitment to fostering a thriving workplace culture that is innovative, empathetic, inclusive and collaborative,” said Jeffrey M. Dayno, M.D., Interim Chief Executive Officer and Chief Medical Officer. “Every day, I see our team of experts from a wide variety of backgrounds and disciplines demonstrate their shared conviction and teamwork in bringing hope to the people and communities we serve. This recognition is a testament to our employees across our entire organization and the important work they do, which I am very proud of.”

PLYMOUTH MEETING, PA, February 7, 2023 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will report fourth quarter and full year 2022 financial results on Tuesday, February 21, 2023, before the open of the U.S. financial markets. Harmony will host a conference call and live webcast on February 21, 2023, at 8:30 a.m. ET to discuss the results.

To participate in the call, please dial (800) 225-9448 (domestic) or +1 (203) 518-9708 (international), and reference passcode HRMYQ422. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, January 6, 2023 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that John Jacobs is stepping down as president and chief executive officer and a member of the Board of Directors to pursue another opportunity. The Harmony Board of Directors has named Jeffrey Dayno, MD, Harmony’s Executive Vice President and Chief Medical Officer, as interim CEO effective immediately. Jeff Aronin, Harmony’s founder and Board chairman, will continue to lead the Board of Directors as well as provide counsel and guidance to the senior management team through the transition as Executive Chairman.

"We have full confidence in Dr. Dayno taking over as CEO on an interim basis," said Aronin, executive chairman of Harmony’s Board. "He has been instrumental in leading our clinical development programs and regulatory strategy as our Chief Medical Officer for the past five years. He is a nationally recognized expert in neuroscience and has been responsible for managing the research, development and medical and regulatory affairs for Harmony. The Board is confident that Harmony’s underlying business continues to be strong, and the team will continue to execute on its strategic imperative while driving long-term value."

PLYMOUTH MEETING, PA, December 22, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that President and CEO, John C. Jacobs will present at the upcoming 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023, at 4:30 p.m. PT/ 7:30 p.m. ET.

A live audio webcast of the presentation will be available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/.

PLYMOUTH MEETING, PA, November 9, 2022 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's management will participate in a fireside chat and host investor meetings at the upcoming Piper Sandler 34th Annual Healthcare Conference.

• Piper Sandler 34th Annual Healthcare Conference
  • Location: New York, NY
  • Fireside Chat: Wednesday, November 30, 2022, at 9:00 am ET
  • 1x1 Meetings: Wednesday, November 30, 2022

A webcast of the fireside chat will be available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/.

PLYMOUTH MEETING, PA, November 1, 2022 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today reported financial results and business updates for the quarter ended September 30, 2022.

“We delivered another strong quarter of performance, reflecting the underlying demand for WAKIX and the significant unmet need that persists in the narcolepsy market,” stated John C. Jacobs, President and Chief Executive Officer of Harmony.

“In addition, we are encouraged by the positive signal seen on the primary outcome of excessive daytime sleepiness from our Phase 2 proof-of-concept study in Prader Willi syndrome and the progress we are making in our clinical programs, as we continue executing on our three-pillar growth strategy.”

PLYMOUTH MEETING, PA, November 1, 2022 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced initial topline results from its Phase 2 proof-of-concept study in patients with Prader-Willi syndrome (PWS), which showed a positive signal on improvement in the primary outcome related to excessive daytime sleepiness (EDS).

The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of pitolisant in patients with PWS. This proof-of-concept study was not powered to demonstrate statistical significance and was designed for signal detection. The study included patients ages 6 to 65 years and patients were randomized 1:1:1 to low dose pitolisant, high dose pitolisant, or placebo treatment groups. Pitolisant dosing was based on three age cohorts (children 6 to < 12; adolescents 12 to < 18; and adults 18 to 65) and another objective of the study was to evaluate for a dose-response to pitolisant in patients with PWS. The primary endpoint of this study was the evaluation of EDS as measured by change from baseline to end of treatment (EOT) on the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) Parent/Caregiver Version.

PLYMOUTH MEETING, PA, October 18, 2022 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will report third quarter 2022 financial results on Tuesday, November 1, 2022, before the open of the U.S. financial markets. Harmony will host a conference call and live webcast on November 1, 2022, at 8:30 a.m. ET to discuss the results.

To participate in the call, please dial (800) 225-9448 (domestic) or +1 (203) 518-9708 (international), and reference passcode HRMYQ322. It is recommended that you dial in at least 10 minutes prior to the call.

The live and replayed webcast of the call will be available on the investor page of our website at https://ir.harmonybiosciences.com/.

PLYMOUTH MEETING, PA, September 22, 2022 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced on the fourth annual World Narcolepsy Day, the funding recipients of its Patients at the Heart and Progress at the Heart award programs.

The Patients at the Heart program, which launched in 2019, underscores Harmony’s ongoing commitment to support the comprehensive needs of people affected by rare neurological diseases. Over the last four years, the program has awarded numerous nonprofit organizations that are working to support and address the challenges of people living with sleep disorders and rare neurological diseases who experience excessive daytime sleepiness (EDS).

In 2021, Harmony initiated the Progress at the Heart program. This award funds innovative programs that address health disparities and inequities in rare neurological disease and sleep disorder communities. Combined with the Patients at the Heart awards, total funding for these two programs has now increased to $380,000 in over the last four years.

“Combining empathy with innovation to improve the lives of people living with rare neurological diseases is a mission that drives everyone at Harmony Biosciences,” said Cate McCanless, Chief Corporate Affairs Officer. “In recognition of World Narcolepsy Day, we are pleased to announce this year’s recipients of the Patients at the Heart and Progress at the Heart award programs. This diverse group of organizations have each developed new and innovative patient-centric initiatives to help address the unique needs of people living with rare neurological diseases. We look forward to the positive impact these programs will create for patients, caregivers and communities.”

PLYMOUTH MEETING, PA, August 17, 2022 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company focused on delivering innovative therapies that improve the health of people living with rare neurological diseases, today announced that Harmony’s management will participate in the following upcoming investor conferences:

2022 Wells Fargo Healthcare Conference

• Location: Boston, MA
• Fireside Chat: Wednesday, September 7, 2022, at 2:35 p.m. ET
• 1x1 Meetings: Wednesday, September 7, 2022

Citi's 17th Annual BioPharma Conference

• Location: Boston, MA
• 1x1 Meetings: Thursday, September 8, 2022

WAKIX^® (pitolisant) Net Revenue of $107.0 Million for Second Quarter 2022 Increase of 45% vs. the Same Period in 2021

Average Number of Patients on WAKIX Increased to ~4,300

Signs New Agreement with Bioprojet Focused on Developing Innovative Therapeutics Based on Pitolisant, Expanding Harmony’s Opportunity in Narcolepsy

Phase 3 Idiopathic Hypersomnia (IH) INTUNE Study on Track with Site Activations and Patient Enrollment

Conference Call and Webcast to be Held Today at 8:30 a.m. ET

PLYMOUTH MEETING, PA, August 2, 2022 — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company focused on delivering innovative therapies that improve the health of people living with rare neurological diseases, today reported financial results and business updates for the quarter ended June 30, 2022.

PLYMOUTH MEETING, PA, July 19, 2022— Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will issue a press release on the Company’s second quarter 2022 financial results on Tuesday, August 2, 2022. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (800) 459-5346 (domestic) or +1 (203) 518-9544 (international), and reference passcode HRMYQ222. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, June 6, 2022— Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced results of a post-hoc analysis from the pivotal data evaluating the clinical impact of WAKIX^® (pitolisant) on the reduction of excessive daytime sleepiness (EDS) and cataplexy in adults with a high burden of narcolepsy symptoms. The analysis was presented as a poster at the 36th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as "SLEEP 2022," held in Charlotte, NC June 4-8.

"The results from this post-hoc analysis of data from randomized, controlled trials in the clinical development program for WAKIX presented at SLEEP 2022 reinforce the clinical effectiveness of WAKIX in patients with a high burden of narcolepsy symptoms," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. "Clinical impact, quantified through effect size metrics, lends another perspective on the efficacy profile of WAKIX, especially when assessed in patients with high symptom burden."

PLYMOUTH MEETING, PA, May 3, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company focused on delivering innovative therapies that improve the health of people living with rare neurological diseases, today reported financial results and business updates for the first quarter ended March 31, 2022.

"In Q1, we continued to execute on our three-pillar growth strategy, with another quarter of significant progress. WAKIX^® underlying business fundamentals remained strong, despite anticipated seasonal payer dynamics. March 2022 represented our strongest month of performance in top line prescription demand and new patient starts in over a year, and we also reached an important milestone, surpassing $500 million in cumulative net revenue for WAKIX since launch, demonstrating the differentiated product profile and unmet need in the narcolepsy market," stated John C. Jacobs, President and Chief Executive Officer of Harmony.

PLYMOUTH MEETING, PA, April 27, 2022— Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the initiation of its Phase 3 trial evaluating the efficacy and safety of pitolisant in adult patients with idiopathic hypersomnia (IH), known as the INTUNE study.

"There has been much interest by both the patient community and healthcare professionals in pitolisant for the treatment of IH and we are excited about the initiation of our Phase 3 INTUNE study in adult patients with this rare neurological disorder," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. "Given the novel mechanism of action of pitolisant, which works through histamine, an important wake-promoting neurotransmitter in the brain, we are looking to translate innovative science into therapeutic possibilities that have the potential to improve the health of people living with IH."

PLYMOUTH MEETING, PA, April 19, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will issue a press release on the Company’s first quarter 2022 financial results on Tuesday, May 3, 2022. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (866) 342-8591 (domestic) or +1 (203) 518-9713 (international), and reference passcode HRMYQ122. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, April 7, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological diseases, is now accepting applications for the second annual Progress at the Heart program, which funds innovative programs that address disparities, injustice, and inequities in the rare neurological disease and sleep disorder communities.

PLYMOUTH MEETING, PA, April 4, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's President and CEO, John C. Jacobs, will present a company update and host investor meetings at the upcoming 21st Annual Needham Virtual Healthcare Conference.

PLYMOUTH MEETING, PA, March 31, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the company was certified as a Great Place to Work^® for the fourth consecutive year. This accolade is based on survey feedback from Harmony employees that evaluates workplace culture and the employee experience.

"Year after year, we’ve shown that teamwork and a healthy company culture can lead to a fulfilling work experience and productivity that supports positive company growth," said John C. Jacobs, Harmony’s President and Chief Executive Officer. "We believe our company’s culture and dedication directly translates to our passion for helping people living with rare neurological diseases lead better lives, and we’re honored to receive this recognition for the fourth year in a row."

PLYMOUTH MEETING, PA, March 17, 2022— Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for people living with rare neurological diseases, today announced applications open on "World Sleep Day", Friday, March 18, 2022, for its Patients at the Heart Program. This funding opportunity is open to nonprofit organizations that are working to support and address the challenges of people living with sleep disorders and rare neurological diseases who experience excessive daytime sleepiness (EDS).

"With this program, we are reinforcing our commitment to supporting the comprehensive needs of people affected by rare neurological diseases, including sleep disorders, and their families," said Cate McCanless, Harmony’s Chief Corporate Affairs Officer. "By understanding the unique challenges faced by those in the rare disease community and providing support, we are able to meet these needs with empathy and make a positive impact."

PLYMOUTH MEETING, PA, March 9, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that its executive leaders will participate in the following upcoming virtual conferences:

PLYMOUTH MEETING, PA, February 28, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today reported financial results and business updates for the fourth quarter and full year ended December 31, 2021.

"Our performance in 2021 demonstrated the team’s commitment and ability to execute on our three-pillar growth strategy designed to support long-term, sustainable value creation. The sequential quarter-over-quarter revenue growth we have achieved since launching WAKIX is supported by the positive feedback from both healthcare providers and patients who are gaining experience with WAKIX," stated John C. Jacobs, President and Chief Executive Officer of Harmony. "In 2022, we expect ongoing growth of WAKIX due to continued strong underlying demand. We are also excited to initiate our Phase 3 registrational trial in Idiopathic Hypersomnia in the first half of this year. Finally, our dedicated business development team remains focused on acquiring new assets to expand our portfolio beyond WAKIX."

PLYMOUTH MEETING, PA, February 14, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will issue a press release on the Company’s fourth quarter and full year 2021 financial results on Monday, February 28, 2022. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 7277008. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, January 5, 2022 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's President and CEO, John C. Jacobs will present a company update and host investor meetings at the upcoming 40th Annual J.P. Morgan Healthcare Conference.

PLYMOUTH MEETING, PA, December 17, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NBI). Harmony’s addition to the NBI will become effective prior to market open on Monday, December 20, 2021.

"We are excited that Harmony will be included in the NASDAQ Biotechnology Index and believe this exemplifies the progress we have made in 2021 on our three-pillar growth strategy," said John C. Jacobs, Harmony's President and Chief Executive Officer. "Our focus is on treatments for patients living with rare neurological diseases and inclusion in the index will showcase our advancements with the broader investment community."

PLYMOUTH MEETING, PA, December 13, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced publication of a data analysis in the December issue of CNS Drugs that evaluates time to onset of response to pitolisant for excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy.

The publication, Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients with Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials, is also available to view online. The post-hoc analysis evaluates data from HARMONY 1 and HARMONY CTP, two randomized, double-blind, 7-week or 8-week clinical trials of pitolisant where patients were titrated to a potential maximum dose of 35.6 mg/day. Efficacy was assessed by the Epworth Sleepiness Scale (ESS) and weekly rate of cataplexy. Onset of response was defined as the first timepoint of statistical difference between pitolisant and placebo.

PLYMOUTH MEETING, PA, December 1, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for pitolisant for the treatment of idiopathic hypersomnia (IH). Harmony is planning to initiate a Phase 3 clinical trial to evaluate the safety and efficacy of pitolisant in adult patients with IH in the first half of 2022.

"We are excited to announce this latest development consistent with our goal to expand the utility of pitolisant beyond narcolepsy where we hope to have an opportunity to help even more patients living with rare neurological diseases," said John C. Jacobs, President and Chief Executive Officer of Harmony Biosciences. "Initiating a Phase 3 trial in patients with IH will accelerate our clinical pipeline for pitolisant and, if successful, would potentially give us the opportunity to pursue our next new indication for WAKIX^®."

PLYMOUTH MEETING, PA, November 22, 2021 – Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced the appointment of Linda Szyper to the Company’s Board of Directors.

Ms. Szyper brings extensive healthcare and pharmaceutical knowledge with expertise anchored in more than 30 years of experience that spans both pharmaceutical sales and marketing as well as healthcare communications services. Most recently, Ms. Szyper served as the Chief Operating Officer of McCann Health, a global healthcare communications company, where she was responsible for the development and overall operations of the global healthcare network. On Harmony’s Board of Directors, she will serve as a member of the Nominating and Corporate Governance Committees.

PLYMOUTH MEETING, PA, November 11 ,2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's President and CEO, John C. Jacobs, will participate in fireside chats and host investor meetings at the following upcoming virtual conferences:

PLYMOUTH MEETING, PA, November 9, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today reported financial results and business updates for the quarter ended September 30, 2021.

"The company continues to execute on optimizing the performance of WAKIX, demonstrated by another solid quarter of sequential revenue growth with an average number of patients on WAKIX of approximately 3,500," stated John C. Jacobs, President and Chief Executive Officer of Harmony. "Inclusion of WAKIX in the recently updated AASM clinical practice guideline is further evidence of its favorable benefit-risk profile. We believe this updated clinical practice guideline has resulted in increased awareness of WAKIX by healthcare professionals who are seeking meaningfully differentiated treatment options for people living with narcolepsy. Our vision remains focused on building Harmony into a leading neurological disease company serving patients suffering from rare diseases, for which there is high unmet medical need. In addition to optimizing WAKIX’s performance, our three-pillar growth strategy also includes broadening the clinical utility of WAKIX in additional indications, as well as acquiring new assets."

PLYMOUTH MEETING, PA, October 26, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will issue a press release on the Company’s third quarter 2021 financial results on Tuesday, November 9, 2021. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 4387084. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, October 21, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that it will be added to the S&P SmallCap 600^® Index, effective prior to the open of trading on Friday, October 22, 2021.

"We are very pleased that Harmony will be included in the S&P SmallCap 600^® Index and are proud of this recognition," said John C. Jacobs, President and Chief Executive Officer of Harmony. "We believe the inclusion in the index will increase our visibility and raise awareness of the work we are doing to help patients, as we continue to build a leading rare neurological disease company."

PLYMOUTH MEETING, PA, September 22, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced winners of the Patient at the Heart and Progress at the Heart programs in honor of the third annual World Narcolepsy Day.

The Patients at the Heart program was created in 2019, and awards funds to not-for-profit organizations working to support and address the challenges of people living with sleep disorders and rare diseases who experience excessive daytime sleepiness (EDS). Initiated in 2021, Progress at the Heart supports innovative programs that address disparities, injustice, and inequities in the rare disease and sleep disorder community.

PLYMOUTH MEETING, PA, September 2, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that the American Academy of Sleep Medicine (AASM) has published an updated clinical practice guideline which includes WAKIX^® (pitolisant) as a recommended treatment option for adults living with narcolepsy.

PLYMOUTH MEETING, PA, September 2, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that Harmony's President and CEO, John C. Jacobs, will participate in fireside chats and host investor meetings at the following upcoming virtual conferences:

PLYMOUTH MEETING, PA, August 10, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today reported financial results and business updates for the second quarter ended June 30, 2021.

"Harmony has made significant progress towards growing the company through our three pillars growth strategy during the first half of 2021," stated John Jacobs, President and Chief Executive Officer of Harmony. "Building on the momentum we saw in the first quarter of this year, we continue to advance the commercialization of WAKIX^® with strong second quarter revenues due to both an increase in average number of patients on WAKIX and the number of healthcare professionals prescribing the product.

PLYMOUTH MEETING, PA, & NEW YORK, August 10, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases and Blackstone (NYSE: BX), today announced that they have entered into a strategic financing collaboration where funds managed by Blackstone have agreed to provide Harmony with up to $330 million of financing and growth capital.

"We are pleased to partner with Blackstone, one of the world’s leading investment firms with strong transactional experience in life sciences and healthcare," said John C. Jacobs, President and Chief Executive Officer of Harmony Biosciences. "This financing provides us with further flexibility to grow our business by providing us with access to capital to expand our portfolio of assets in rare, neurological diseases while also reducing our annual interest expense."

PLYMOUTH MEETING, PA, August 9, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological diseases, today announced the acquisition of HBS-102 (formerly CSTI-100), a potential first-in-class molecule with a novel mechanism of action, from ConSynance Therapeutics, Inc., a clinical stage biotechnology company focused on rare central nervous system diseases. Under the terms of the agreement, Harmony will acquire full development and commercialization rights globally, with the exception of Greater China, with financial terms including an upfront payment of $3.5 million and potential development and regulatory milestone payments and royalties.

"The acquisition of HBS-102 represents our first addition to the pipeline beyond WAKIX^® (pitolisant), and our intention is to continue to pursue additional assets in line with our vision of becoming a leading rare neurological disease company with a robust portfolio of products," said John C. Jacobs, President and Chief Executive Officer of Harmony.

PLYMOUTH MEEETING, PA, July 29, 2021 – Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that John C. Jacobs, President and CEO, has been named an EY Entrepreneur Of The Year^® 2021 Greater Philadelphia Award Winner.

Jacobs was selected by a panel of independent judges for his work leading Harmony and joins an esteemed multi-industry community of other entrepreneurs who have driven their companies’ success, transformed their industries, and made a positive impact on their employees and communities.

PLYMOUTH MEETING, PA, July 27, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that it will issue a press release on the Company’s second quarter 2021 financial results on Tuesday, August 10, 2021 at 8:00 a.m. ET. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 2955734. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, June 29, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced initiation of a Phase 2 clinical trial to evaluate the safety and efficacy of pitolisant for excessive daytime sleepiness (EDS) and other non-muscular symptoms in adult patients with type 1 myotonic dystrophy (DM1).

"In addition to the primary symptoms of myotonia and muscle weakness in patients with type 1 myotonic dystrophy, the non-muscular symptoms of excessive daytime sleepiness, fatigue, and cognitive dysfunction are very common in these patients and have a negative impact on daily functioning as much as, or more so, than the primary muscle symptoms of the disease," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. "Pitolisant’s novel mechanism of action increases histamine transmission in the brain which provides the scientific rationale for its potential clinical utility for the common non-muscular symptoms in patients with DM1. We listened to the needs of patients and caregivers in the myotonic dystrophy patient community and are pleased to have initiated this Phase 2 clinical trial to assess the potential clinical benefit of pitolisant in patients with this rare neurological disease, for which there are currently no approved treatment options."

PLYMOUTH MEETING, PA, June 10, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced results of a new analysis evaluating number needed to treat (NNT) and effect sizes for treatment with WAKIX^® (pitolisant) that demonstrates the magnitude of its clinical effectiveness for excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. The poster was presented at the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as "SLEEP 2021," held virtually June 10-13.

PLYMOUTH MEETING, PA, June 9, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced applications for its Patients at the Heart Grant Program open Wednesday, June 9, 2021 for patient-centric organizations working to support and address the challenges of people living with sleep disorders and rare diseases who experience excessive daytime sleepiness (EDS).

The Patients at the Heart Grant, a competitive grant opportunity, was developed to underscore Harmony’s ongoing commitment to support the comprehensive needs of people affected by sleep disorders. Since its launch in 2019, awards have funded innovative patient-centric programs, with the most recent grants specifically awarded to programs created to support and address the unique challenges of people living with narcolepsy during the COVID-19 pandemic.

PLYMOUTH MEETING, PA, June 7, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that results from two post-hoc analyses from the clinical development program for WAKIX^® (pitolisant) will be presented at the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as "SLEEP 2021." The meeting will be held virtually June 10-13.

One of the poster presentations is a new analysis that calculated the number needed to treat (NNT) and effect size of WAKIX to demonstrate the magnitude of its clinical effectiveness. The second poster is based on an analysis of the cataplexy data from the clinical development program for WAKIX.

PLYMOUTH MEETING, PA, May 26, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that Harmony’s President and CEO, John Jacobs, will participate in fireside chats and host investor meetings at the following upcoming virtual conferences:

PLYMOUTH MEETING, PA, May 18, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that Harmony’s President and CEO, John C. Jacobs and Chief Medical Officer, Dr. Jeffrey Dayno will present a company update and host investor meetings at the Oppenheimer Rare and Orphan Disease Summit on Friday, May 21, 2021.

PLYMOUTH MEETING, PA, May 18, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the appointment of John C. Jacobs, President and CEO of Harmony, to the Life Sciences Pennsylvania’s (LSPA) Board of Directors, effective May 6, 2021.

John Jacobs’ election to the board is accompanied by other leaders representing the breadth, diversity and geographic reach of LSPA across the medical device, diagnostic, biopharmaceutical, and research communities, bringing important expertise, insights, and partnerships that will help enhance the association’s effectiveness. He will provide insight and guidance to the association given his deep experience of almost three decades in the pharmaceutical and life sciences industry.

PLYMOUTH MEETING, PA, May 11, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony", or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today reported financial results and business updates for the first quarter ended March 31, 2021.

"We are off to a very strong start in 2021 with the continued demand for WAKIX^® driving strong first quarter net revenues," stated John C. Jacobs, President and Chief Executive Officer of Harmony. "We saw growth in the average number of patients on WAKIX and net revenue, putting us in the position of profitability this quarter, for the first time in our company history, demonstrating our resilience and performance through the lingering pandemic and anticipated seasonal payer dynamics in Q1.

PLYMOUTH MEETING, PA, April 27, 2021 — Harmony Biosciences Holdings, Inc. ("the Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that data from three analyses of the clinical development program for WAKIX^® (pitolisant), a medication approved for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy, will be presented at the 2021 American Psychiatric Association (APA) Annual Meeting, to be held virtually May 1-3. Two of the three poster presentations feature analyses of efficacy and safety data from the clinical development program for WAKIX in adult patients with narcolepsy and the third is based on a post-hoc analysis that evaluated the time to onset of clinical response for WAKIX.

"Both excessive daytime sleepiness and cataplexy can have a significant impact on a person’s daily functioning, which may greatly affect their social, emotional and psychological well-being," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. "Given this, and the fact that sleep disorders are co-morbid with several different psychiatric disorders, we are pleased to share these data for WAKIX with the psychiatry and mental health professional communities for the first time."

PLYMOUTH MEETING, PA, April 27, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare, neurological disorders who have unmet medical needs, today announced that it will issue a press release on the Company’s first quarter 2021 financial results on Tuesday, May 11, 2021 at 8:00 a.m. ET. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 2269379. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, April 12, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that results from two analyses from the clinical development program for WAKIX^® (pitolisant) will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually April 17-22. One of the poster presentations is based on a post-hoc analysis that evaluated the time-to-onset of clinical response for WAKIX and the second poster is based on a pooled analysis of the cardiovascular safety data from the clinical development program for WAKIX in adult patients with narcolepsy.

"These analyses further characterize the efficacy and safety profile of WAKIX and its broad clinical utility for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. "We look forward to sharing these data and the results of these analyses with both the neurology and narcolepsy communities."

PLYMOUTH MEETING, PA, April 7, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the launch of a new grant program, Progress at the Heart, to accelerate programs and solutions that address inequity in access to diagnosis, treatment, and care in the rare disease and sleep disorder community.

Many people from underrepresented racial, ethnic, or other minority groups often face an even greater disparity in access to care, particularly given underrepresentation in research and clinical trials. In recognition of World Health Day and National Minority Health Month this April, Progress at the Heart seeks community- and education-based solutions and grant applications are currently being accepted. Up to $125,000 in grants will be awarded by September 2021 in an effort to help achieve greater equality of care within the sleep disorder community.

PLYMOUTH MEETING, PA, March 25, 2021 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today reported its financial results and business updates for the fourth quarter and full year ended December 31, 2020.

PLYMOUTH MEETING, PA, March 19, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced publication of a white paper sharing outcomes from a Summit on Sleep Disruption the company hosted in December 2020. For the first time, this summit convened a diverse group of people living with rare diseases, caregivers and leaders of advocacy organizations, who represented diseases in which sleep disruption has been recognized, to discuss the role excessive daytime sleepiness (EDS) plays in their respective conditions.

In many therapeutic areas, treatment is a balance of – or decision between – managing symptoms, including those not as well known or manifested, and addressing the underlying cause of the disease. Often in rare diseases, one such "hidden" symptom is EDS. The goals of the summit were to describe the physical, emotional, social and cognitive challenges faced by patients with EDS; the challenges they face in having this symptom diagnosed; and its overall impact and burden on daily functioning.

PLYMOUTH MEETING, PA, March 17, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that results of a post-hoc analysis of data from two Phase 3 clinical trials of pitolisant, a histamine 3 (H₃) receptor antagonist/inverse agonist, have been published online in Sleep Medicine. The analysis focused on patients in the trials who suffered from a high burden of narcolepsy symptoms, including both excessive daytime sleepiness (EDS) and cataplexy.

The publication, Efficacy of Pitolisant in Patients with High Burden of Narcolepsy Symptoms: Pooled Analysis of Short-Term, Placebo-Controlled Studies reports data pooled from two randomized, placebo-controlled, 7-or 8-week studies in adult patients with narcolepsy, in which pitolisant could be titrated to a maximum dose of 35.6 mg/day.

PLYMOUTH MEETING, PA, March 15, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the appointment of Sandip Kapadia as Chief Financial Officer effective March 29, 2021. Mr. Kapadia is an accomplished executive with more than two decades of operational experience in leading finance operations, supporting commercialization, raising capital and providing strategic guidance within the healthcare sector.

"We are very pleased to welcome Sandip to Harmony. His broad and deep financial leadership experience will be an asset as we continue to build upon the momentum of 2020. Sandip’s expertise as a strategic and tactical financial executive will contribute significantly to our business as we plan to deliver long-term growth to our company and key stakeholders," said John C. Jacobs, Harmony’s President and Chief Executive Officer.

PLYMOUTH MEETING, PA, March 4, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that it will issue a press release on the Company’s fourth quarter and full year 2020 financial results on Thursday, March 25, 2021 at 8:00 a.m. ET. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 5049024. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA, March 2, 2021 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today that the company has been certified by independent analysts as a Great Place to Work^® for the third year in a row. This certification is based on validated feedback from Harmony’s employees in an anonymous survey intended to determine exceptional workplace cultures.

"At Harmony, our team works hard each day to make a difference in the lives of patients and their families who live with rare neurological disorders," said John C. Jacobs, President and CEO. "We are pleased to receive this honor for the third year and grateful that Harmony team members experience the company as a welcoming, caring and collaborative environment that aims to make a positive impact in the patient community."

PLYMOUTH MEETING, PA and CHICAGO, IL, December 17, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the Company will be added to the Russell 2000^® and Russell 3000^® Indexes effective after the U.S. market closes on Friday, December 18.

"Inclusion in the Russell 2000^® and Russell 3000^® Indexes is an important milestone for Harmony", said John C. Jacobs, Harmony’s President and Chief Executive Officer. "We believe it will enhance Harmony’s visibility in the investment community and broaden our shareholder base."

PLYMOUTH MEETING, PA and CHICAGO, IL, December 15, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the first patient has been enrolled in a Phase 2 trial evaluating the safety and efficacy of pitolisant for the treatment of excessive daytime sleepiness (EDS) and other key symptoms in patients with Prader-Willi Syndrome (PWS).

"We view pitolisant as a portfolio in a product opportunity and are taking a mechanism-based approach to drug development in managing its life cycle with the goal of expanding its clinical utility," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. "We believe pitolisant could offer an important therapeutic benefit in people living with PWS based on preclinical models of the disorder, pitolisant’s demonstrated efficacy in improving EDS in patients with narcolepsy, and anecdotal evidence in patients with PWS. We look forward to continuing our collaboration with the Foundation for Prader-Willi Research, the Prader-Willi Syndrome Association USA, and the patient and family community as we advance our development program in order to help address this unmet medical need."

PLYMOUTH MEETING, PA and CHICAGO, IL, November 12, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today reported financial results for the quarter ended September 30, 2020, and provided recent business updates.

"Harmony experienced another productive quarter with continued WAKIX revenue growth and meaningful advancement of our key clinical programs," commented John C. Jacobs, Harmony’s President and Chief Executive Officer. "WAKIX sales continued to increase on a quarterly basis through the COVID-19 pandemic, reflecting the unmet medical need for a first-in-class medication with a novel mechanism of action. The recent approval of the cataplexy indication for WAKIX expanded the label in narcolepsy which, along with WAKIX being the only FDA approved product for narcolepsy that is not scheduled as a controlled substance, provides additional commercial opportunity. With a robust cash position stemming from our recent IPO, we have the financial resources to continue supporting our commercialization efforts for WAKIX, advance our clinical programs, and to pursue the acquisition of additional assets that would be complimentary to our existing commercial footprint and core areas of expertise."

PLYMOUTH MEETING, PA and CHICAGO, IL, November 11, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the appointment of Mark Graf and Eric Motley to the Company’s Board of Directors. Mark Graf is an executive with deep financial expertise as well as an experienced board member with a strong background in corporate governance. Eric Motley is an expert in human capital development who has advised previous government, not-for-profit and private sector organizations as an organizational development executive, in addition to his governance experience on corporate and philanthropic boards.

"The wealth of financial, management and governance expertise Mark and Eric bring adds to the depth and breadth of Harmony’s board," said Jeff Aronin, Harmony Founder and Chairman, and Paragon Biosciences Chairman and CEO. "Their insights will be invaluable to help oversee the strategic growth of Harmony as a public company. We are honored to have them join our Board."

PLYMOUTH MEETING, PA and CHICAGO, IL, October 28, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced that it will issue a press release on the Company’s third quarter financial results on Thursday, November 12, 2020 at 8:00 a.m. ET. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

To participate in the call, please dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 7489154. It is recommended that you dial in at least 10 minutes prior to the call.

PLYMOUTH MEETING, PA and CHICAGO, IL, October 13, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has approved WAKIX^® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

"All people living with narcolepsy have excessive daytime sleepiness and up to two-thirds of them also experience cataplexy, which is one of the most debilitating symptoms of this chronic, rare neurological disorder," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. "Today’s FDA approval of the cataplexy indication for WAKIX, coupled with it being the first and only non-scheduled treatment option approved for adult patients with narcolepsy to treat both excessive daytime sleepiness or cataplexy, provides an opportunity for WAKIX to offer broad clinical utility to healthcare professionals managing adult patients living with narcolepsy."

PLYMOUTH MEETING, PA and CHICAGO, IL, September 22, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced recipients of the second-annual Patients at the Heart Grant in recognition of World Narcolepsy Day. The Patients at the Heart Grant was originally designed as an annual competitive grant opportunity dedicated to funding innovative patient-centric programs; however, this year’s grants were specifically awarded to programs created to support and address the unique challenges of people living with narcolepsy during the COVID-19 pandemic.

"We are proud to recognize the second-annual World Narcolepsy Day by continuing to support the narcolepsy community, especially during a year when all of us need support more than ever," said Cate McCanless, Harmony’s Vice President, External Affairs. "Being able to pivot our Patients at the Heart Grant opportunity to fund programs that support and address the challenges of people with narcolepsy during the COVID-19 pandemic underlines our commitment to keeping patients at the heart of everything we do."

PLYMOUTH MEETING, PA, and CHICAGO, IL, August 28, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today results from post-hoc analyses of the efficacy and safety data for WAKIX^® (pitolisant) presented at the 34^th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as "SLEEP 2020." The meeting is being held virtually from August 27—30. Harmony is presenting a total of four posters in the Virtual SLEEP 2020 Exhibit Hall, three of which are post-hoc analyses of the efficacy and safety data from the clinical development program for WAKIX.

"We are pleased to participate in this year’s SLEEP 2020 virtual meeting and share clinically relevant data supporting WAKIX with healthcare professionals and the sleep medicine community," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. "The results presented from post-hoc analyses of the clinical data help further characterize the efficacy and safety profile of WAKIX to assist healthcare professionals in making treatment decisions for their patients living with narcolepsy."

PLYMOUTH MEETING, PA, and CHICAGO, IL, August 24, 2020 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today it will present new data on the safety and efficacy of WAKIX^® (pitolisant), including four poster presentations at the upcoming 34th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as “SLEEP 2020.” The meeting is being held virtually from August 27-30. Abstracts of the WAKIX data will also be published in the journal SLEEP as an online supplement.

The data include a final analysis of the Pitolisant Expanded Access Clinical Evaluation Program (PEACE), two post-hoc analyses on clinically relevant outcomes from the Phase 3 clinical trials, and analyses that further characterize the cardiac safety profile of WAKIX from the clinical development program.

PLYMOUTH MEETING, PA and CHICAGO, IL, August 21, 2020 — Harmony Biosciences Holdings, Inc. (“Harmony”), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced it has closed its upsized initial public offering of 6,151,162 shares of common stock, including 802,325 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares of common stock, at the public offering price of $24.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Harmony, are expected to be $147.6 million. All of the shares were offered by Harmony.

Harmony shares began trading on the Nasdaq Global Market under the ticker symbol “HRMY” on August 19, 2020.

PLYMOUTH MEETING, PA and CHICAGO, IL, August 18, 2020 — Harmony Biosciences Holdings, Inc., a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today the pricing of its upsized initial public offering of 5,348,837 shares of common stock at a price to the public of $24.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Harmony, are expected to be $128.4 million. In addition, Harmony has granted the underwriters a 30-day option to purchase up to an additional 802,325 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares are being offered by Harmony.

The shares are expected to begin trading on the Nasdaq Global Market under the ticker symbol “HRMY” on August 19, 2020. The offering is expected to close on August 21, 2020, pending customary closing conditions.

PLYMOUTH MEETING, PA, July 30, 2020 — Harmony Biosciences (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare, neurological diseases, announced today that the company is a recipient of Life Sciences Pennsylvania’s (LSPA) 2019 Patient Impact Award. Harmony was selected as an honoree based on the company’s continued efforts to support patients living with narcolepsy.

“At Harmony, patients are at the heart of everything we do. It is an honor to be recognized by LSPA for our work to contribute to the health and wellbeing of people living with narcolepsy,” said Cate McCanless, Vice President of External Affairs at Harmony. “We are proud to be recognized as a company that is making a difference in the lives of patients through our continued focus on scientific innovation, advocacy, and patient education.”

PLYMOUTH MEETING, PA, June 2, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it uploaded two posters with data on the efficacy and safety of WAKIX^® (pitolisant) to the American Academy of Neurology (AAN) Science Highlights virtual platform. The abstracts of these posters are also included in an online supplement of the journal Neurology in the “Sleep Medicine: Focus on Therapies 2” poster session.

“We are pleased to have an opportunity to share these important data via this innovative approach with the broader neurology community,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “These data on the efficacy and safety of WAKIX strengthen the body of scientific evidence that supports WAKIX as a potential treatment option for adult patients living with narcolepsy.”

PLYMOUTH MEETING, PA, April 29, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that the company has been recognized nationally among the top 10 biopharmaceutical companies on the 2020 Fortune Best Workplaces in Health Care & Biopharma™ list. Harmony earned this accolade based on an independent analysis conducted by Great Place to Work^®, following results of a comprehensive, anonymous survey examining employee satisfaction and their workplace experiences.

“At Harmony, we put the wellbeing of the patients we serve and each of our employees at the heart of all we do,” said John C. Jacobs, President and CEO. “Being recognized by Fortune as a Best Workplace is an honor and speaks to the dedication our team has to upholding our company’s core values, maintaining a supportive and inclusive culture, and delivering value to patients by embracing innovation.”

PLYMOUTH MEETING, PA, April 27, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing new treatment options for people living with rare diseases, today announced the company will expand narcolepsy community support efforts and reinforced its commitment to provide affordable access to treatment for people who have experienced a change in insurance or financial instability during the ongoing COVID-19 pandemic.

Harmony’s Patients at the Heart grant program underscores the company’s ongoing commitment to support the comprehensive needs of people affected by narcolepsy. The second annual Patients at the Heart grant program is being launched with increased funding to further support patient-centric organizations working to address the challenges of people living with narcolepsy during this time. The company’s patient support program will continue to provide medication free of charge for eligible patients who have lost health insurance or are underinsured, while providing “contactless” shipping for home delivery.

PLYMOUTH MEETING, PA, March 30, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that Sleep Medicine has published an article which reviews the mechanism of action (MOA) of available treatments for patients with narcolepsy.

PLYMOUTH MEETING, PA, February 3, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that the company has been certified as a great workplace for the second year in a row by independent analysts at Great Place to Work^®. Harmony earned this credential based on ratings by its employees in an anonymous survey that provides benchmarks, framework and assessment to recognize outstanding workplace cultures.

“At Harmony, we keep patients at the heart of everything that we do, and everyone has ownership in the success of our company,” said John C. Jacobs, President and CEO. “We were deeply honored that, for the second year in a row, Harmony team members who participated in the survey rated the company as a ‘great place to work’ and cited our culture of one-team attitude, honest and transparent ways of working, and the ability to make a difference for patients and the broader community as contributing to an overall positive workplace experience.”

PLYMOUTH MEETING, PA, January 27, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it has completed a $200 million debt facility with OrbiMed Advisors LLC (“OrbiMed”), one of the leading investors in the healthcare industry, to provide additional capital to fuel the company’s continued growth.

“We are pleased to announce the completion of this debt facility with OrbiMed, a leading healthcare public and private market investment firm,” said John C. Jacobs, Chairman and CEO of Harmony. “With this financing, Harmony will be well positioned to continue to develop new medications consistent with our goal of helping additional people living with rare diseases.”

PLYMOUTH MEETING, PA, November 20, 2019 — Harmony Biosciences, LLC (Harmony) announced today that data from two clinical studies evaluating the long-term safety and efficacy, as well as the human abuse potential of WAKIX^® (pitolisant), have been published in SLEEP. WAKIX is a first-in-class medication with a novel mechanism of action and is approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. It is the first and only U.S. Food and Drug Administration (FDA) approved product for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

PLYMOUTH MEETING, PA, September 20, 2019 — Harmony Biosciences, LLC (Harmony) announced today the recipients of the inaugural Patients at the Heart Grant, a competitive grant opportunity to fund innovative, patient-centric programs for the narcolepsy community. Applicants were asked to submit proposals describing the goals of their program and how it will benefit people living with narcolepsy, as well as an evaluation plan with measurable indicators of success.

The original 2019 grant award was $50,000, but following the review of each application, the Patients at the Heart Grant review committee selected four organizations to receive grants totaling $65,000. The review committee was comprised of a diverse group of experts including cross-functional Harmony executives, a healthcare professional specializing in sleep disorders medicine and research, and a person living with narcolepsy.

PLYMOUTH MEETING, PA, September 16, 2019 — Harmony Biosciences, LLC, (Harmony) announced today it will present clinical data on the efficacy and safety of WAKIX^® (pitolisant) at the World Sleep 2019 meeting in Vancouver, Canada, from September 20-25, 2019. In an oral presentation, results will be presented from a randomized, double-blind, active- and placebo-controlled, four-sequence, four-way crossover study that evaluated the abuse potential of pitolisant compared with the stimulant phentermine HCl (C-IV) and placebo in non-dependent, recreational stimulant users. In addition, seven scientific posters will be presented, including a new post-hoc analysis of pooled data from two randomized, placebo-controlled, seven- and eight-week studies of pitolisant in adults with narcolepsy that evaluated the efficacy of WAKIX in patients with a high burden of narcolepsy symptoms.

PLYMOUTH MEETING, PA, August 15, 2019 — Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved WAKIX^® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

“We are extremely proud to bring WAKIX to market for those living with narcolepsy, a chronic, debilitating, rare neurologic disorder,” said Harmony’s Chairman and Chief Executive Officer, John C. Jacobs. “At Harmony we share a vision to develop novel treatment options for people living with rare diseases, with a focus on those that affect the central nervous system. The approval of WAKIX strengthens our commitment to making that vision a reality.”

PLYMOUTH MEETING, PA, June 17, 2019 — Harmony Biosciences, LLC (Harmony) today announced the launch of the first Patients at the Heart Grant, a competitive grant opportunity to fund innovative patient-centric programs for the narcolepsy community. As part of Harmony’s overall commitment to supporting the comprehensive needs of people living with narcolepsy, Harmony has committed an initial $50,000 to this program.

“Keeping patients at the heart of everything we do is our main focus,” said Cate McCanless, Harmony’s Vice President, External Affairs. “We recognize there is an unmet need for support within the narcolepsy community and are hopeful we receive innovative ideas from organizations that allow us to support people living with narcolepsy and their families.”

PLYMOUTH MEETING, PA, June 4, 2019 — Harmony Biosciences, LLC (Harmony) announced today it will present data on the safety and tolerability of pitolisant, which has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy, at the upcoming 33rd Annual Meeting of the Associated Professional Sleep Societies, known as “SLEEP” in San Antonio, Texas from June 8-12. In addition to integrated data from clinical studies on the safety and tolerability of pitolisant, Harmony’s presentations will highlight data from a human abuse potential study of pitolisant, the pitolisant U.S. expanded access program, and an analysis of pitolisant in combination with other medications for the treatment of narcolepsy.

“As a company dedicated to novel treatments for rare disorders, we are pleased to share a broad range of data for pitolisant at this year’s SLEEP meeting,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D.

PLYMOUTH MEETING, PA, April 29, 2019 — Harmony Biosciences, LLC (Harmony) today announced it will present data on the efficacy and safety of pitolisant, which has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy, at the upcoming 2019 American Academy of Neurology (AAN) annual meeting in Philadelphia, May 4-10. Harmony is a biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases.

“We are pleased to have the opportunity to present data on pitolisant at this year’s AAN annual meeting demonstrating our commitment to investigating treatment options for people living with rare diseases such as narcolepsy,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D.

PLYMOUTH MEETING, PA, March 13, 2019 — Harmony Biosciences, LLC (Harmony), a private biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it has entered into a $200 million debt facility with CR Group L.P. (CRG), a premier healthcare-focused investment firm, to provide additional working capital to fuel the company’s continued growth.

“This financing illustrates our confidence in the continued growth of the company and, importantly, in the significant potential of Harmony to bring new treatment options to those who live with rare diseases,” said John C. Jacobs, President and CEO of Harmony. “In addition to our original private equity raises totaling $295 million, the flexibility and strength afforded by this debt facility positions the company extremely well to achieve our future goals and address unmet medical needs, in line with our mission.”

PLYMOUTH MEETING, PA, February 12, 2019 — Harmony Biosciences, LLC (Harmony), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its investigational product, pitolisant, and has granted Priority Review for this NDA. Pitolisant is a first-in-class molecule with a novel mechanism of action; it is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist for the potential treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy. A Priority Review designation by the FDA indicates that, if approved, pitolisant would provide a significant improvement in the safety or effectiveness of the treatment of EDS and/or cataplexy in adult patients with narcolepsy when compared to existing treatments. Harmony’s goal is to obtain FDA approval to market pitolisant in the U.S. in 2019.

PLYMOUTH MEETING, PA, February 4, 2019— Harmony Biosciences, LLC (Harmony), a private biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that the company has been certified as a great workplace by independent analysts at Great Place to Work^®. Harmony earned this credential based on extensive ratings by its employees in an anonymous survey that provides benchmarks, framework and assessment to recognize outstanding workplace cultures.

PLYMOUTH MEETING, PA, December 5, 2018 — Harmony Biosciences, LLC (Harmony) announced today that the company has received four industry awards for its Know Narcolepsy^® disease awareness educational campaign and healthcare professional educational video series. The company was selected as an Award of Excellence winner in two categories for Launch Campaign and Physician Education by the 32nd Annual Rx Club Show, and two Honorable Mentions for its Video Programs as part of the PR News Healthcare Communications and Digital Awards.

PLYMOUTH MEETING, PA, October 9, 2018 — Results of a three-part survey of those living with narcolepsy (n=200), treating physicians (n=251) and the general public (n=1,203) bring to light the serious impact of this rare, chronic neurologic disorder on daily life. The Know Narcolepsy™ survey, conducted by Versta Research among a total of 1,654 respondents on behalf of Harmony Biosciences, LLC, in collaboration with patient advocacy organization, Narcolepsy Network, highlighted that narcolepsy is life-changing for the majority (86 percent, n=172) of those surveyed living with the disorder. However, 78 percent (n=938) of the general public surveyed agreed they have no idea what it must be like to live with narcolepsy, which impacts up to 200,000 Americans.

PLYMOUTH MEETING, PA, September 27, 2018 — Harmony Biosciences, LLC (Harmony) announced today that French pharmaceutical company Bioprojet SCR (Bioprojet) presented new human abuse potential (HAP) data on pitolisant at the 24th Congress of the European Sleep Research Society (ESRS) in Basel, Switzerland. Pitolisant is an investigational product in the U.S. that was studied in Europe and approved by the European Medicines Agency (EMA) in 2016 for the treatment of adult patients with narcolepsy with or without cataplexy. Harmony acquired exclusive rights in 2017 to develop and register pitolisant in the U.S.

PLYMOUTH MEETING, PA, September 12, 2018 — Harmony Biosciences, LLC (Harmony), a private biopharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, today announced the opening of its completed, 15,651 square foot headquarters in Plymouth Meeting, PA, located at 630 W. Germantown Pike. The company, established in October 2017, was honored to host Pennsylvania Governor Tom Wolf at a ribbon-cutting ceremony, as well as Chris Molineaux, President and Chief Executive Officer of Life Sciences Pennsylvania (LSPA).

PLYMOUTH MEETING, PA, September 11, 2018 — Harmony Biosciences, LLC (Harmony) presented new data on pitolisant at the 7 th International Symposium on Narcolepsy in Beverly, MA. Pitolisant is an investigational product that has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy. Long term data (up to 5-years) from the Harmony III open-label, naturalistic study were presented in a platform presentation. These data assessed the safety, tolerability and durability of effect of pitolisant, the first potent and highly selective histamine 3 (H3 ) receptor antagonist/inverse agonist. If approved, pitolisant would represent the first new therapy in the U.S. in over a decade for the treatment of both EDS and cataplexy in patients with narcolepsy.

PLYMOUTH MEETING, PA, September 5, 2018 — Harmony Biosciences, LLC (Harmony) today announced that it will present scientific data on its investigational product, pitolisant, which has been studied for the treatment of both excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy, at the upcoming 7th International Symposium on Narcolepsy in Beverly, MA from September 9-13.

PLYMOUTH MEETING, PA, May 31, 2018 — Harmony Biosciences, LLC (Harmony), a Paragon Biosciences, LLC, portfolio company, today announced that it will present scientific data on its investigational product, pitolisant, which is being studied for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy, at the upcoming 32nd Annual Meeting of the Associated Professional Sleep Societies, known as "SLEEP", in Baltimore, MD from June 3-6.

PLYMOUTH MEETING, PA, May 21, 2018 — Harmony Biosciences, LLC (Harmony), today announced that it has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the U.S. Food and Drug Administration (FDA). Breakthrough Therapy designation has been granted for pitolisant for the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Fast Track designation has been granted for the investigation of pitolisant for the treatment of excessive daytime sleepiness in patients with narcolepsy and the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. These designations signal FDA’s interest in the development program for pitolisant and provide opportunities for frequent interaction with the Agency, the ability to request a rolling new drug application (NDA) submission, as well as the potential for expedited review.