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

Harmony Biosciences (NASDAQ:HRMY) announced its participation in the upcoming 2025 Cantor Global Healthcare Conference. The company's management team will engage in a fireside chat on September 4, 2025, at 2:10 p.m. ET in New York. Investors can access the webcast through the company's investor relations website.

Harmony Biosciences (NASDAQ:HRMY) reported strong Q2 2025 financial results, with WAKIX® net revenue reaching $200.5M, representing 16% year-over-year growth. The company increased its average patient count by 400 to 7,600 patients in Q2 2025.

Key pipeline developments include the upcoming Phase 3 Fragile X syndrome (FXS) topline data in Q3 2025, targeting an 80,000-patient market opportunity. The company plans to initiate Phase 3 trials for Pitolisant HD in narcolepsy and idiopathic hypersomnia in Q4 2025, targeting PDUFA dates in 2028.

Financial highlights include GAAP net income of $39.8M ($0.68 per diluted share) and non-GAAP adjusted net income of $53.8M ($0.92 per diluted share). The company maintains a strong cash position of $672.3M and reaffirms its 2025 revenue guidance of $820-860M.

Harmony Biosciences (Nasdaq: HRMY) has scheduled its second quarter 2025 financial results announcement for Tuesday, August 5, 2025, before U.S. markets open. The company will host a conference call and webcast at 8:30 a.m. ET on the same day to discuss the results.

Investors can participate by dialing 833-316-2483 (domestic) or 785-838-9284 (international) using passcode HRMYQ225. A live and replay webcast will be accessible on the company's investor relations website.

Harmony Biosciences (Nasdaq: HRMY) announced its management team will participate in the upcoming H.C. Wainwright "HCW@Home" virtual series. The fireside chat is scheduled for Thursday, July 17, 2025, at 10:00 a.m. ET. Investors can register in advance through a provided link, and a webcast will be available on the company's investor relations website.

Harmony Biosciences (NASDAQ: HRMY) has presented promising preclinical data for BP1.15205, their investigational orexin 2 receptor (OX2R) agonist, at SLEEP 2025. The compound demonstrated significant wake-promoting and cataplexy-suppressing effects in narcolepsy mouse models. BP1.15205 showed high potency with EC50 = 0.015 nM and >600-fold selectivity for OX2R over OX1R receptors. The 3-month toxicity study revealed no concerning adverse events at doses up to 300 mg/kg/day. The compound showed effectiveness at very low doses and potential for once-daily dosing. Harmony plans to begin first-in-human studies in H2 2025 with topline data expected in 2026, following IMPD application with EMA and IND filing with FDA.

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.