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Vertex Pharmaceuticals (VRTX) FDA Events

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FDA Events for Vertex Pharmaceuticals (VRTX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Vertex Pharmaceuticals (VRTX). Over the past two years, Vertex Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CASGEVY, exagamglogene, suzetrigine, vanza, Vanzacaftor/Tezacaftor/Deutivacaftor,, VX-548, and VX-880. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Vertex Pharmaceuticals' Drugs in FDA Review

CASGEVY - FDA Regulatory Timeline and Events

CASGEVY is a drug developed by Vertex Pharmaceuticals for the following indication: For the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT). 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.

exagamglogene autotemcel - FDA Regulatory Timeline and Events

exagamglogene autotemcel is a drug developed by Vertex Pharmaceuticals for the following indication: For severe sickle cell disease. 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.

suzetrigine - FDA Regulatory Timeline and Events

suzetrigine is a drug developed by Vertex Pharmaceuticals for the following indication: For the Treatment of Moderate-to-Severe Acute Pain. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

vanza triple - FDA Regulatory Timeline and Events

vanza triple is a drug developed by Vertex Pharmaceuticals for the following indication: Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis. 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.

Vanzacaftor/Tezacaftor/Deutivacaftor, - FDA Regulatory Timeline and Events

Vanzacaftor/Tezacaftor/Deutivacaftor, is a drug developed by Vertex Pharmaceuticals for the following indication: For people living with cystic fibrosis (CF). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

VX-548 - FDA Regulatory Timeline and Events

VX-548 is a drug developed by Vertex Pharmaceuticals for the following indication: for the Treatment of Painful Diabetic Peripheral Neuropathy. 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.

VX-880 - FDA Regulatory Timeline and Events

VX-880 is a drug developed by Vertex Pharmaceuticals for the following indication: 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemic awareness. 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.

Vertex Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, Vertex Pharmaceuticals (VRTX) has received FDA approval for multiple therapies, including suzetrigine and Vanzacaftor/Tezacaftor/Deutivacaftor,. This page tracks recent and historical FDA regulatory events related to Vertex Pharmaceuticals' drug portfolio.

In the past two years, Vertex Pharmaceuticals (VRTX) has reported FDA regulatory activity for the following drugs: Vanzacaftor/Tezacaftor/Deutivacaftor,, suzetrigine, VX-880, CASGEVY, vanza triple, exagamglogene autotemcel and VX-548.

The most recent FDA-related event for Vertex Pharmaceuticals occurred on July 3, 2025, involving exagamglogene autotemcel. The update was categorized as "Positive Data," with the company reporting: "Vertex Pharmaceuticals announced positive longer-term data for PrCASGEVY® (exagamglogene autotemcel) from global ongoing pivotal clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT)."

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

  • For people living with cystic fibrosis (CF) - Vanzacaftor/Tezacaftor/Deutivacaftor,
  • For the Treatment of Moderate-to-Severe Acute Pain - suzetrigine
  • 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemic awareness - VX-880
  • For the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT) - CASGEVY
  • Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis - vanza triple
  • For severe sickle cell disease - exagamglogene autotemcel
  • for the Treatment of Painful Diabetic Peripheral Neuropathy - VX-548

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:VRTX) was last updated on 7/9/2025 by MarketBeat.com Staff
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