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

Harmony Biosciences Holdings, Inc. (HRMY) announced the winners of its Patients at the Heart and Progress at the Heart programs on the third annual World Narcolepsy Day. More than $180,000 was awarded to eight organizations supporting individuals with sleep disorders and rare diseases. The Patients at the Heart program, created in 2019, funds not-for-profits addressing challenges faced by those with excessive daytime sleepiness. The new Progress at the Heart program addresses disparities in the rare disease community.

Harmony Biosciences Holdings (Nasdaq: HRMY) announced an update from the American Academy of Sleep Medicine (AASM) that includes WAKIX^® (pitolisant) as a recommended treatment for narcolepsy in adults. The updated clinical guideline published in the Journal of Clinical Sleep Medicine emphasizes WAKIX's efficacy in significantly improving excessive daytime sleepiness and cataplexy. WAKIX has been available in the U.S. since Q4 2019 and received both orphan drug and breakthrough therapy designations. This inclusion is expected to help healthcare professionals make informed treatment decisions.

Harmony Biosciences Holdings (Nasdaq: HRMY), a pharmaceutical company focused on rare neurological diseases, announced that President and CEO John C. Jacobs will engage in fireside chats and investor meetings at several upcoming virtual conferences. Key events include the Citi's 16th Annual BioPharma Virtual Conference on September 8-9, the 2021 Virtual Wells Fargo Healthcare Conference on September 10, and the 2021 Cantor Virtual Global Healthcare Conference on September 28. A live audio webcast of the fireside chat will be accessible on Harmony's investor page.

Harmony Biosciences reported a 94.2% increase in net revenue to $73.8 million for Q2 2021, up from $38 million in Q2 2020. Positive net income reached $14.1 million or $0.24 per diluted share, reversing a loss from the previous year. The company initiated a Phase 2 trial for myotonic dystrophy and acquired HBS-102, a potential first-in-class treatment for narcolepsy. Additionally, a strategic financing collaboration with Blackstone secured up to $330 million to support growth.

Harmony Biosciences (Nasdaq: HRMY) and Blackstone (NYSE: BX) announced a strategic financing collaboration worth up to $330 million. The deal includes $300 million in debt capital and a $30 million equity investment. The financing will enable Harmony to expand its portfolio focused on rare neurological diseases and reduce its annual interest expenses. The initial $200 million term loan proceeds will primarily be used to eliminate existing debt, significantly lowering Harmony's capital costs. This partnership aims to enhance the company's growth trajectory in the pharmaceutical sector.

On August 9, 2021, Harmony Biosciences (Nasdaq: HRMY) announced its acquisition of HBS-102, a potential first-in-class molecule for treating narcolepsy. The deal includes an upfront payment of $3.5 million, alongside potential milestone payments and royalties. HBS-102 targets melanin concentrating hormone (MCH) neurons, aiming to alleviate symptoms like cataplexy and REM sleep dysregulation. Harmony plans to submit an Investigational New Drug application to initiate a Phase 2 clinical trial. This acquisition marks Harmony's strategy to expand its product pipeline beyond its current offering, WAKIX®.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will announce its second quarter 2021 financial results on August 10, 2021, at 8:00 a.m. ET. A conference call and webcast will follow at 8:30 a.m. ET. Investors can join the call by dialing (833) 614-1471 (domestic) or +1 (914) 987-7209 (international). A replay will be available within 24 hours, lasting until August 17, 2021. Harmony Biosciences focuses on developing therapies for rare neurological disorders and aims to address unmet medical needs.

Harmony Biosciences Holdings (Nasdaq: HRMY) announced the initiation of a Phase 2 clinical trial to evaluate the safety and efficacy of pitolisant for excessive daytime sleepiness (EDS) and non-muscular symptoms in adult patients with type 1 myotonic dystrophy (DM1). Approximately 135 patients will receive low-dose, high-dose, or placebo pitolisant in a randomized study. The trial aims to address significant unmet medical needs as there are currently no approved treatments for DM1. Topline results are expected in the second half of 2022.