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

Harmony Biosciences (HRMY) has reached a settlement agreement with Lupin Limited regarding patent infringement litigation over WAKIX (pitolisant hydrochloride). The settlement allows Lupin to launch its generic version no earlier than January 2030 (or July 2030 with pediatric exclusivity). WAKIX is the first non-scheduled FDA-approved treatment for excessive daytime sleepiness and cataplexy in adult narcolepsy patients, and for EDS in pediatric narcolepsy patients 6+ years old. The company is developing next-generation pitolisant formulations with potential patent exclusivity until 2044. Notably, the U.S. Patent Office recently declined to review Harmony's polymorph patent, reinforcing their IP portfolio's strength. Harmony continues to defend its patents against other ANDA filers seeking generic WAKIX approvals.

Harmony Biosciences Holdings (NASDAQ: HRMY) announced its management team will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference. The event will take place in Miami, FL on Monday, June 9, 2025, at 3:20 p.m. ET. Investors and interested parties can access the webcast of the discussion through Harmony's investor relations website at https://ir.harmonybiosciences.com/.

Harmony Biosciences (HRMY) reported strong Q1 2025 financial results, with WAKIX® net revenue reaching $184.7 million, representing a 20% year-over-year growth. The company reaffirmed its 2025 revenue guidance of $820-$860 million. Net income grew 19% year-over-year to $45.6 million, with cash and investments exceeding $600 million. The average number of WAKIX patients increased to approximately 7,200 in Q1. Key pipeline developments include completed recruitment for ZYN002's Phase 3 trial in Fragile X Syndrome (topline data expected Q3), upcoming BP1.15205 orexin data presentation, and planned Phase 3 trials for next-generation Pitolisant-HD in Q4. The company maintains a strong commercial foundation while advancing multiple late-stage pipeline candidates across sleep/wake, neurobehavioral, and rare epilepsy franchises.

Harmony Biosciences (Nasdaq: HRMY) has scheduled its first quarter 2025 financial results announcement for Tuesday, May 6, 2025, before U.S. financial markets open.

The company will host a conference call and webcast at 8:30 a.m. ET on the same day to discuss the quarterly results. Interested participants can join using:

• Domestic dial-in: 800-267-6316
• International dial-in: 203-518-9783
• Passcode: HRMYQ125

Participants are advised to dial in at least 10 minutes before the call begins. A live webcast and replay will be accessible through the investor relations section of Harmony's website at ir.harmonybiosciences.com.

Harmony Biosciences (NASDAQ: HRMY) presented updated data from its Open-Label Extension (OLE) study of ZYN002 for Fragile X Syndrome (FXS) treatment. The study demonstrated clinically meaningful improvements in irritability-related symptoms in patients.

Key findings include:

• Over 60% of participants achieved clinically meaningful improvement of ≥9 points on ABC-CFXS Irritability scores
• After three years, ~73% of patients experienced clinically meaningful improvements
• Treatment-related adverse events occurred in 12.9% of patients, with application site pain being most common (6.7%)

The study included 240 patients aged 3-17 years, with data collected from September 2018 to January 2024. The company expects topline data from its Phase 3 RECONNECT study in Q3 2025. Currently, there are no FDA-approved treatments for FXS, which affects approximately 80,000 individuals in the U.S.

Harmony Biosciences (Nasdaq: HRMY) has appointed Ron Philip to its Board of Directors. Philip, currently President and CEO of Orbital Therapeutics, brings 30 years of experience in company building, organizational growth, and therapeutic development. His notable previous role was CEO of Spark Therapeutics, where he led the commercial launch of a novel gene therapy for inherited blindness and expanded the company's therapeutic platform.

Philip's extensive background includes leadership positions at Pfizer and Wyeth, serving as regional president for Africa/Middle East and heading various strategic initiatives. He currently serves on the boards of City Therapeutics and Life Sciences Cares Pennsylvania. The appointment aligns with Harmony's focus on pipeline expansion through business development, as the company aims to leverage Philip's expertise in identifying new technologies that benefit patients while creating shareholder value.

Harmony Biosciences (Nasdaq: HRMY) has announced its upcoming participation in the 24th Annual Needham Virtual Healthcare Conference. The company's management team will engage in a fireside chat scheduled for Wednesday, April 9, 2025, at 3:00 p.m. ET.

Interested parties can access the webcast of the discussion through the investor relations section of Harmony's website at https://ir.harmonybiosciences.com/.

Harmony Biosciences (Nasdaq: HRMY) has appointed Adam Zaeske as Executive Vice President and Chief Commercial Officer (CCO), effective March 31, 2025, replacing Jeffrey Dierks who is stepping down for personal reasons.

Zaeske brings 25 years of pharmaceutical industry leadership experience, most recently serving as Head of Central, South, and Eastern Europe at Takeda Pharmaceuticals, where he managed a $2 billion business across 25 countries. At Harmony, he will lead the commercial organization, drive market expansion, and oversee execution across all brands and geographies.

The appointment comes as Harmony builds on the commercial success of WAKIX® (pitolisant) in narcolepsy and prepares to advance its late-stage pipeline assets. The company maintains its 2025 revenue guidance and projects WAKIX to be a $1B plus opportunity in adult narcolepsy alone.

Harmony Biosciences (Nasdaq: HRMY) has announced its management team's upcoming participation in two major healthcare investor conferences in Miami, FL. The company will attend the Barclays Global Healthcare Conference on Tuesday, March 11, 2025, followed by the Leerink Partners Global Healthcare Conference on Wednesday, March 12, 2025.

At the Leerink conference, Harmony will participate in a fireside chat scheduled for 1:00 p.m. ET. Investors can access the webcast of this discussion through the investor relations section of Harmony's website at ir.harmonybiosciences.com.