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

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.

Business Wire • Dec 8, 2025

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

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.

Business Wire • Dec 2, 2025

Harmony Biosciences Announces Positive Results From the Pivotal Bioequivalence Study for Pitolisant Gastro-Resistant Formulation

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant gastro-resistant (GR) formulation. With positive findings from both the pivotal BE and dosing optimization studies, Harmony is on track to submit a New Drug Application (NDA) for pitolisant GR in early 2026, targeting a PDUFA date in Q1 2027. With utility patent applications filed for pitolisant GR with potent.

Business Wire • Nov 24, 2025

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

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.

Business Wire • Nov 19, 2025

Harmony Biosciences to Participate in Upcoming Investor Conferences

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in the following upcoming investor conferences. Citi's 2025 Global Healthcare Conference Location: Miami, FL Tuesday, December 2, 2025 8th Annual Evercore Healthcare Conference Location: Miami, FL Fireside Chat: Tuesday, December 2, 2025, at 2:35 p.m. ET Piper Sandler 37th Annual Healthcare Conference Location: New York, NY Fireside Chat: Wed.

Business Wire • Nov 18, 2025

Harmony Biosciences Holdings, Inc. (HRMY) Q3 2025 Earnings Call Transcript

Harmony Biosciences Holdings, Inc. ( HRMY ) Q3 2025 Earnings Call November 4, 2025 8:30 AM EST Company Participants Matthew Beck Jeffrey Dayno - President, CEO & Director Adam Zaeske - Executive VP & Chief Commercial Officer Kumar Budur - Executive VP and Chief Medical & Scientific Officer Sandip Kapadia - Executive VP, Chief Administrative Officer & CFO Conference Call Participants Ami Fadia - Needham & Company, LLC, Research Division David Amsellem - Piper Sandler & Co., Research Division Graig Suvannavejh - Mizuho Securities USA LLC, Research Division Jay Olson - Oppenheimer & Co. Inc., Research Division Pete Stavropoulos - Cantor Fitzgerald & Co., Research Division Danielle Brill Bongero - Truist Securities, Inc., Research Division Patrick Trucchio - H.C. Wainwright & Co, LLC, Research Division Ashwani Verma - UBS Investment Bank, Research Division David Hoang - Deutsche Bank AG, Research Division Presentation Operator Good morning.

Seeking Alpha • Nov 4, 2025

Harmony Biosciences Reports Strong Q3 2025 Financial Results; Recently Raised 2025 Revenue Guidance to $845-$865M

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings of $239.5M for Q3 2025, representing 29% year-over-year revenue growth for WAKIX®. These results were driven by the highest ever increase in average number of patients of approximately 500 for the quarter, accelerating the trajectory toward blockbuster status for WAKIX in narcolepsy. The company continues to build on four consecutive years of revenue growth and profitability. With.

Business Wire • Nov 4, 2025

Harmony Biosciences Holdings, Inc. (HRMY) Q3 Earnings Miss Estimates

Harmony Biosciences Holdings, Inc. (HRMY) came out with quarterly earnings of $0.87 per share, missing the Zacks Consensus Estimate of $0.92 per share. This compares to earnings of $0.79 per share a year ago.

Zacks Investment Research • Nov 4, 2025

Harmony Biosciences Holdings, Inc. (HRMY) Earnings Expected to Grow: Should You Buy?

Harmony Biosciences (HRMY) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Zacks Investment Research • Oct 28, 2025

Harmony Biosciences (HRMY) Moves 12.7% Higher: Will This Strength Last?

Harmony Biosciences (HRMY) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Zacks Investment Research • Oct 24, 2025