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BioCryst Pharmaceuticals (BCRX) FDA Events

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FDA Events for BioCryst Pharmaceuticals (BCRX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by BioCryst Pharmaceuticals (BCRX). Over the past two years, BioCryst Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as BCX17725, ORLADEYO, and RAPIVAB. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

BioCryst Pharmaceuticals' Drugs in FDA Review

BCX17725 - FDA Regulatory Timeline and Events

BCX17725 is a drug developed by BioCryst Pharmaceuticals for the following indication: For the Treatment of Netherton 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.

ORLADEYO (berotralstat) - FDA Regulatory Timeline and Events

ORLADEYO (berotralstat) is a drug developed by BioCryst Pharmaceuticals for the following indication: Hereditary angioedema (HAE). 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.

RAPIVAB - FDA Regulatory Timeline and Events

RAPIVAB is a drug developed by BioCryst Pharmaceuticals for the following indication: For the treatment of influenza. 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.

BioCryst Pharmaceuticals FDA Events - Frequently Asked Questions

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

In the past two years, BioCryst Pharmaceuticals (BCRX) has reported FDA regulatory activity for the following drugs: ORLADEYO (berotralstat), BCX17725 and RAPIVAB.

The most recent FDA-related event for BioCryst Pharmaceuticals occurred on June 16, 2025, involving ORLADEYO (berotralstat). The update was categorized as "New Data," with the company reporting: "BioCryst Pharmaceuticals, Inc. ( announced new data on the long-term efficacy and safety of ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) in patients across all age groups."

Current therapies from BioCryst Pharmaceuticals in review with the FDA target conditions such as:

  • Hereditary angioedema (HAE) - ORLADEYO (berotralstat)
  • For the Treatment of Netherton Syndrome - BCX17725
  • For the treatment of influenza. - RAPIVAB

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:BCRX) was last updated on 7/10/2025 by MarketBeat.com Staff
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