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Ventyx Biosciences (VTYX) FDA Events

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FDA Events for Ventyx Biosciences (VTYX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Ventyx Biosciences (VTYX). Over the past two years, Ventyx Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as VTX2735, VTX3232, and VTX958. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ventyx Biosciences' Drugs in FDA Review

VTX2735 - FDA Regulatory Timeline and Events

VTX2735 is a drug developed by Ventyx Biosciences for the following indication: For Parkinson's 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.

VTX3232 - FDA Regulatory Timeline and Events

VTX3232 is a drug developed by Ventyx Biosciences for the following indication: In patients with early Parkinson's 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.

VTX958 - FDA Regulatory Timeline and Events

VTX958 is a drug developed by Ventyx Biosciences for the following indication: Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and lupus. 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.

Ventyx Biosciences FDA Events - Frequently Asked Questions

In the past two years, Ventyx Biosciences (VTYX) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Ventyx Biosciences (VTYX) has reported FDA regulatory activity for the following drugs: VTX3232, VTX958 and VTX2735.

The most recent FDA-related event for Ventyx Biosciences occurred on June 17, 2025, involving VTX3232. The update was categorized as "Top-line results," with the company reporting: "Ventyx Biosciences, Inc. announced positive top-line results from its Phase 2a study of VTX3232, a novel, CNS-penetrant NLRP3 inhibitor, in patients with early-stage Parkinson's disease (NCT06556173)."

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

  • In patients with early Parkinson's disease. - VTX3232
  • Psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and lupus - VTX958
  • For Parkinson's disease - VTX2735

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:VTYX) was last updated on 7/11/2025 by MarketBeat.com Staff
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