HRMY News

Harmony Biosciences Presents Clinically Meaningful Open-Label Extension Study Effectiveness Data for EPX-100 in Dravet Syndrome

HRMY

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the presentation of initial open-label extension (OLE) data from the company’s ongoing Phase 3 ARGUS trial investigating EPX-100 (clemizole hydrochloride) for the treatment of Dravet syndrome (DS), which showed clinically meaningful reductions in seizure activity in participants with DS along with a favorable benefit-risk profile. The data from poster #3.353 will be presented at the Americ

December 8, 2025
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Harmony Biosciences to Present New Open-Label Extension Data from Phase 3 ARGUS Trial at the 2025 American Epilepsy Society Annual Meeting

HRMY

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will highlight new open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2025 American Epilepsy Society (AES) Annual Meeting being held December 5 – December 9, 2025, in Atlanta, GA. The ARGUS trial is currently enrolling, and more information can be found at arg

December 2, 2025
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Harmony Biosciences Announces Initiation of First-In-Human Study With Potential Best-In-Class Orexin 2 Receptor Agonist (BP1.15205) for Central Disorders of Hypersomnolence

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PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced dosing of the first participant in a Phase 1 clinical trial of BP1.15205, an investigational, potentially best-in-class, orexin 2 receptor (OX2R) agonist being developed for the treatment of narcolepsy, idiopathic hypersomnia and other central disorders of hypersomnolence. The Phase 1 clinical trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BP1.15205 aft

November 19, 2025
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Harmony Biosciences to Present Rare Epilepsy Data at the 36th International Epilepsy Congress

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PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will present data from its rare epilepsy pipeline at the 36th International Epilepsy Congress (IEC) being held August 30 – September 3, 2025, at the Lisbon Congress Centre in Lisbon, Portugal. Poster presentations will highlight information from the company’s investigation of EPX-100 (clemizole hydrochloride) in two Phase 3 clinical studies (ARGUS and LIGHTHOUSE) for the treatment

Harmony Biosciences to Participate in 2025 Cantor Global Healthcare Conference

HRMY

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the 2025 Cantor Global Healthcare Conference in New York, N.Y., on Thursday, September 4, 2025, at 2:10 p.m. ET. A webcast of the fireside chat will be available on the investor page of the Harmony Biosciences website at https://ir.harmonybiosciences.com/. About Harmony Biosciences Harmony Biosciences is a pharmaceutical

Harmony Biosciences Reports Strong Q2 2025 Financial Results and Reaffirms 2025 Revenue Guidance; On Track to Announce Fragile X Topline Data From Phase 3 Registrational Trial in Q3 2025

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PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced plans to announce topline data from its phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome in Q3 2025. The company also announced 16% year-over-year revenue growth for WAKIX® in Q2 2025, driven by strong patient adds of 400 for the quarter, continuing its trajectory toward blockbuster status in narcolepsy and a potential $1B+ market opportunity. The company continues to b

Harmony Biosciences Presents Preclinical Pharmacological Effect Data For BP1.15205, Demonstrating Wake-Promoting And Cataplexy-Suppressing Effects In Standard Transgenic Mouse Model Of Narcolepsy Type 1, At SLEEP 2025

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June 11, 2025
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Harmony Biosciences Presents Preclinical Data Demonstrating Significant Wake-Promoting and Cataplexy-Suppressing Effects of BP1.15205 in Narcolepsy at SLEEP 2025

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PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced the presentation of preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1. The data will be presented at the 39th Annual Meeting of the Associated Professi

Harmony Biosciences Settles With Lupin Resolving Patent Infringement Litigation Related To Lupin's Abbreviated New Drug Application For Generic VersionOof WAKIX; Lupin To Receive License To Launch Generic No Earlier Than Jan. 2030

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June 5, 2025
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Oppenheimer Assumes Harmony Biosciences Hldgs at Outperform, Announces Price Target of $61

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June 2, 2025
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Mizuho Maintains Outperform on Harmony Biosciences Hldgs, Raises Price Target to $48

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May 15, 2025
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Needham Reiterates Buy on Harmony Biosciences Hldgs, Maintains $49 Price Target

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May 7, 2025
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Deep Dive Into Harmony Biosciences Hldgs Stock: Analyst Perspectives (13 Ratings)

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May 6, 2025
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Needham Reiterates Buy on Harmony Biosciences Hldgs, Maintains $49 Price Target

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May 6, 2025
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Harmony Biosciences Hldgs Affirms FY2025 Sales Guidance of $820.00M-$860.00M vs $839.89M Est

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May 6, 2025
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Harmony Biosciences Q1 Adj. EPS $1.03 Beats $0.59 Estimate, Sales $184.73M Beat $182.90M Estimate

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May 6, 2025
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UBS Maintains Buy on Harmony Biosciences Hldgs, Lowers Price Target to $48

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April 28, 2025
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Needham Reiterates Buy on Harmony Biosciences Hldgs, Maintains $50 Price Target

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April 10, 2025
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Breaking Down Harmony Biosciences Hldgs: 13 Analysts Share Their Views

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April 8, 2025
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HC Wainwright & Co. Reiterates Buy on Harmony Biosciences Hldgs, Maintains $70 Price Target

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April 8, 2025
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Needham Reiterates Buy on Harmony Biosciences Hldgs, Maintains $50 Price Target

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April 8, 2025
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Expert Outlook: Harmony Biosciences Hldgs Through The Eyes Of 11 Analysts

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March 18, 2025
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Mizuho Maintains Outperform on Harmony Biosciences Hldgs, Raises Price Target to $44

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March 18, 2025
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Demystifying Harmony Biosciences Hldgs: Insights From 11 Analyst Reviews

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February 27, 2025
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HC Wainwright & Co. Maintains Buy on Harmony Biosciences Hldgs, Lowers Price Target to $70

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February 27, 2025
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Needham Reiterates Buy on Harmony Biosciences, Maintains $50 Price Target

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February 26, 2025
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Needham Reiterates Buy on Harmony Biosciences, Maintains $50 Price Target

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February 25, 2025
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Harmony Biosciences Q4 Adj $1.08 Beats $0.74 Estimate, Sales $201.27M Beat $201.25M Estimate

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February 25, 2025
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Mizuho Maintains Outperform on Harmony Biosciences, Lowers Price Target to $42

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February 20, 2025
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Harmony Biosciences Stock Falls On FDA Setback For Pitolisant In Sleeping Disorder

HRMY

Harmony Biosciences' FDA setback for pitolisant in idiopathic hypersomnia doesn't impact its 2025 revenue outlook, with a Phase 3 trial planned for late 2025.

February 19, 2025
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HC Wainwright & Co. Reiterates Buy on Harmony Biosciences, Maintains $75 Price Target

HRMY

February 19, 2025
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Needham Maintains Buy on Harmony Biosciences, Lowers Price Target to $50

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February 19, 2025
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Harmony Biosciences Receives Refusal To File Letter From FDA For Pitolisant; Says 2025 Net Revenue Guidance Remains Unchanged At $820M-$860M

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February 19, 2025
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Needham Reiterates Buy on Harmony Biosciences, Maintains $52 Price Target

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January 13, 2025
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Harmony Biosciences Reports $714M 2024 Revenue For WAKIX; 2025 Forecast $820M-$860M With Potential $1B+; Key Catalysts In Each Quarter; FDA Review For Pitolisant sNDA, Orexin Data, Fragile X Topline, And Narcolepsy Trial; Six Phase 3 Programs Expected By

HRMY

January 13, 2025
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Reported Earlier, Harmony Biosciences Shareholders Sell 8M Shares at $31 Each in Public Offering

HRMY

October 31, 2024
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Harmony Biosciences: Q1 Earnings Insights

HRMY

Harmony Biosciences (NASDAQ:HRMY) reported its Q1 earnings results on Tuesday, May 3, 2022 at 07:30 AM. Here's what investors need to know about the announcement.

May 3, 2022
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Harmony Biosciences Q1 EPS $0.51 Beats $0.29 Estimate, Sales $85.31M Miss $88.55M Estimate

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May 3, 2022
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