Harmony Biosciences Holdings, Inc. Stock Price, News & Analysis

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced its inclusion in the Russell 2000® and Russell 3000® Indexes, effective after market close on December 18, 2020. This milestone is expected to enhance the company’s visibility among investors and broaden its shareholder base. The Russell 3000® Index features the top 3,000 U.S. publicly traded companies, while the Russell 2000® Index focuses on the smallest-cap companies within this group.

Harmony Biosciences (HRMY) announced that the first patient has been enrolled in a Phase 2 trial assessing pitolisant for treating excessive daytime sleepiness (EDS) in patients with Prader-Willi Syndrome (PWS). This double-blind study will involve 60-70 patients across 10 U.S. sites, aiming for topline results in the first half of 2022. The trial's primary goal is to evaluate improvements in EDS, which affects over half of the 15,000 to 20,000 PWS patients in the U.S. The study represents a significant step in addressing unmet medical needs for this rare disorder.

Harmony Biosciences Holdings reported Q3 2020 net product revenue of $45.6 million, showing growth amid the COVID-19 pandemic. The approval of WAKIX for treating cataplexy in narcolepsy expands its commercial potential, as it remains the only FDA-approved treatment not classified as a controlled substance. The company is poised to initiate a Phase 2 trial for pitolisant in Prader-Willi Syndrome by year-end 2020. Cash and cash equivalents stood at $221.7 million, ensuring ongoing support for commercialization and clinical programs.

Harmony Biosciences has appointed Mark Graf and Eric Motley to its Board of Directors. Graf, a former CFO at Discover Financial Services, brings extensive financial expertise, having managed a $110 billion balance sheet. He was recognized by Institutional Investor as the top CFO in consumer financial services from 2014 to 2019. Motley, with 20 years in talent development, previously served at the White House and currently works with the Aspen Institute. Their appointments are expected to enhance the governance and strategic oversight of Harmony, focusing on innovative therapies for rare neurological disorders.

Harmony Biosciences (Nasdaq: HRMY) announced its third quarter financial results release scheduled for November 12, 2020, at 8:00 a.m. ET. A conference call will follow at 8:30 a.m. ET. Investors can join the call by calling (833) 614-1471 domestically or +1 (914) 987-7209 internationally, with a passcode of 7489154. The live and replayed webcast will be accessible on the company's investor page. Harmony focuses on developing therapies for rare neurological disorders.

Harmony Biosciences (Nasdaq: HRMY) announces FDA approval for WAKIX® (pitolisant) to treat cataplexy in adults with narcolepsy. This marks WAKIX as the first and only non-controlled substance medication for both excessive daytime sleepiness and cataplexy in narcolepsy patients. FDA approval, a result of clinical trials showing significant efficacy, reinforces Harmony's commitment to address unmet medical needs in rare neurological disorders. WAKIX, initially approved in August 2019, offers a novel mechanism of action and aims to improve the quality of life for those affected by narcolepsy.

Harmony Biosciences Holdings (HRMY) announced the recipients of the second-annual Patients at the Heart Grant on World Narcolepsy Day, September 22, 2020. This year, $74,000 was awarded to three organizations, an increase from $65,000 awarded in 2019 to four organizations. The initiative focuses on supporting programs that assist people with narcolepsy, particularly during the COVID-19 pandemic. Notable programs funded include digital support groups and resources aimed at improving the quality of life for individuals affected by narcolepsy.

Harmony Biosciences (Nasdaq: HRMY) presented post-hoc analyses of WAKIX® (pitolisant) data at the virtual SLEEP 2020 meeting, showcasing its efficacy and safety in treating narcolepsy. Key findings included significant improvements in excessive daytime sleepiness and cataplexy reduction compared to placebo, with significant time-to-response from Week 2. The analyses indicated a favorable cardiac safety profile for pitolisant, with no substantial cardiovascular risks observed. These results aim to assist healthcare professionals in treatment decisions for narcolepsy patients.

Harmony Biosciences (Nasdaq: HRMY) announced that it will present new safety and efficacy data on its narcolepsy treatment, WAKIX® (pitolisant), at the 34th Annual Meeting of the Associated Professional Sleep Societies, SLEEP 2020, from August 27-30, 2020. The presentations include findings from the Pitolisant Expanded Access Clinical Evaluation Program and analyses of pitolisant's cardiac safety profile. Harmony's Chief Medical Officer highlighted the importance of these analyses in providing important information for patients and healthcare providers.