AOL

Harmony Biosciences Stock Falls On FDA Setback For Pitolisant In Sleeping Disorder

On Wednesday, Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for excessive daytime sleepiness ...
MyChesCo on MSN

Harmony Biosciences Faces Regulatory Setback, Outlines Future Plans for Pitolisant

PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration ...
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 ...
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 ...
Seeking Alpha

Harmony Biosciences: sNDA Of WAKIX Brings Additional Value Inflection Points

Harmony Biosciences Holdings, Inc. (HRMY) has already been able to receive FDA approval for its drug known as WAKIX [PITOLISANT]. It is for excessive daytime sleepiness [EDS] or cataplexy in adult ...
PharmiWeb

Harmony Biosciences Guides to Over $1 Billion in WAKIX® Revenue in 2026; Advancing Robust Late-Stage Pipeline With Potential for Long-term Value Creation

WAKIX 2025 Preliminary Net Revenue of ~$868 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in NarcolepsyOn Track to Extend the Pitolisant Franchise ...