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Harmony Biosciences (HRMY) FDA Events

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FDA Events for Harmony Biosciences (HRMY)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Harmony Biosciences (HRMY). Over the past two years, Harmony Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BP1.15205, orexin-2, pitolisant, WAKIX, and ZYN002. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Harmony Biosciences' Drugs in FDA Review

BP1.15205 - FDA Regulatory Timeline and Events

BP1.15205 is a drug developed by Harmony Biosciences for the following indication: OX2R agonist drug candidate. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

orexin-2 - FDA Regulatory Timeline and Events

orexin-2 is a drug developed by Harmony Biosciences for the following indication: for inducing sleep and the treatment of insomnia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

pitolisant - FDA Regulatory Timeline and Events

pitolisant is a drug developed by Harmony Biosciences for the following indication: For the treatment of excessive daytime sleepiness. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

WAKIX (pitolisant) - FDA Regulatory Timeline and Events

WAKIX (pitolisant) is a drug developed by Harmony Biosciences for the following indication: Excessive daytime sleepiness or cataplexy in adults with narcolepsy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ZYN002 - FDA Regulatory Timeline and Events

ZYN002 is a drug developed by Harmony Biosciences for the following indication: In Fragile X Syndrome. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Harmony Biosciences FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Harmony Biosciences (HRMY) has reported FDA regulatory activity for the following drugs: BP1.15205, pitolisant, orexin-2, ZYN002 and WAKIX (pitolisant).

The most recent FDA-related event for Harmony Biosciences occurred on June 11, 2025, involving BP1.15205. The update was categorized as "Top-line data," with the company reporting: "Harmony Biosciences Holdings, Inc. announced that topline clinical data is anticipated in 2026"

Current therapies from Harmony Biosciences in review with the FDA target conditions such as:

  • OX2R agonist drug candidate - BP1.15205
  • For the treatment of excessive daytime sleepiness - pitolisant
  • for inducing sleep and the treatment of insomnia. - orexin-2
  • In Fragile X Syndrome - ZYN002
  • Excessive daytime sleepiness or cataplexy in adults with narcolepsy - WAKIX (pitolisant)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:HRMY) was last updated on 7/10/2025 by MarketBeat.com Staff
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