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Werewolf Therapeutics (HOWL) FDA Events

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FDA Events for Werewolf Therapeutics (HOWL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Werewolf Therapeutics (HOWL). Over the past two years, Werewolf Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as WTX-124, WTX-330, WTX-518, WTX-712, and WTX-921. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Werewolf Therapeutics' Drugs in FDA Review

WTX-124 - FDA Regulatory Timeline and Events

WTX-124 is a drug developed by Werewolf Therapeutics for the following indication: Solid Tumors. 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.

WTX-330 - FDA Regulatory Timeline and Events

WTX-330 is a drug developed by Werewolf Therapeutics for the following indication: In multiple tumor types or Non-Hodgkin Lymphoma as a single agent. 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.

WTX-518 - FDA Regulatory Timeline and Events

WTX-518 is a drug developed by Werewolf Therapeutics for the following indication: in cancer therapy. 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.

WTX-712 - FDA Regulatory Timeline and Events

WTX-712 is a drug developed by Werewolf Therapeutics for the following indication: in cancer therapy. 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.

WTX-921 - FDA Regulatory Timeline and Events

WTX-921 is a drug developed by Werewolf Therapeutics for the following indication: for Inflammatory Diseases. 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.

Werewolf Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Werewolf Therapeutics (HOWL) has reported FDA regulatory activity for the following drugs: WTX-330, WTX-124, WTX-921, WTX-712 and WTX-518.

The most recent FDA-related event for Werewolf Therapeutics occurred on May 5, 2025, involving WTX-921. The update was categorized as "Poster Presentation," with the company reporting: "Werewolf Therapeutics, Inc. announced a poster presentation further characterizing its conditionally-activated IL-10 INDUKINE molecule, WTX-921, at IMMUNOLOGY2025, the annual meeting of the American Association of Immunologists (AAI) taking place May 3-7 in Honolulu, Hawaii."

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

  • In multiple tumor types or Non-Hodgkin Lymphoma as a single agent. - WTX-330
  • Solid Tumors - WTX-124
  • for Inflammatory Diseases - WTX-921
  • in cancer therapy. - WTX-712
  • in cancer therapy. - WTX-518

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