Nasdaq

Harmony Biosciences Reports Positive Results For Pitolisant GR; Plans NDA Filing In Early 2026

(RTTNews) - Harmony Biosciences Holdings, Inc. (HRMY) said Monday that a pivotal bioequivalence (BE) study of its pitolisant gastro-resistant (GR) formulation showed that 17.8 mg of pitolisant GR is ...
Morningstar

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

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant gastro-resistant (GR) formulation. With positive ...
St. Louis American

HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR WAKIX® (PITOLISANT) IN PEDIATRIC PATIENTS WITH NARCOLEPSY

The FDA granted priority review of the sNDA based on a Phase 3 study conducted by Bioprojet, which evaluated the safety and efficacy of pitolisant in patients ages 6 to under 18 years with narcolepsy, ...
Business Wire

Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration ...
Seeking Alpha

Viatris Completes Acquisition of Aculys Pharma Including Exclusive Rights to Pitolisant in Japan and to Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region

PITTSBURGH, Oct. 15, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has acquired Aculys Pharma, Inc., a clinical stage biopharmaceutical company ...