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Verastem (VSTM) FDA Events

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FDA Events for Verastem (VSTM)

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

Verastem's Drugs in FDA Review

Avutometinib - FDA Regulatory Timeline and Events

Avutometinib is a drug developed by Verastem for the following indication: For the treatment of low-grade serous ovarian cancer (LGSOC). 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.

RAMP 201 - FDA Regulatory Timeline and Events

RAMP 201 is a drug developed by Verastem for the following indication: Vutometinib (VS-6766) alone and in combination with defactinib among patients with recurrent low-grade serous ovarian cancer (LGSOC). 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.

Verastem FDA Events - Frequently Asked Questions

In the past two years, Verastem (VSTM) 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, Verastem (VSTM) has reported FDA regulatory activity for the following drugs: Avutometinib and RAMP 201.

The most recent FDA-related event for Verastem occurred on May 22, 2025, involving Avutometinib. The update was categorized as "Efficacy and Safety results," with the company reporting: "Verastem Oncology announced positive updated safety and efficacy results from the RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the front-line for patients with metastatic pancreatic ductal adenocarcinoma (PDAC)."

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

  • For the treatment of low-grade serous ovarian cancer (LGSOC) - Avutometinib
  • Vutometinib (VS-6766) alone and in combination with defactinib among patients with recurrent low-grade serous ovarian cancer (LGSOC). - RAMP 201

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