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Intensity Therapeutics (INTS) FDA Events

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FDA Events for Intensity Therapeutics (INTS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Intensity Therapeutics (INTS). Over the past two years, Intensity Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as INT230-6. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

INT230-6 - FDA Regulatory Timeline and Events

INT230-6 is a drug developed by Intensity Therapeutics for the following indication: treatment for certain soft tissue sarcoma subtypes. 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.

Intensity Therapeutics FDA Events - Frequently Asked Questions

As of now, Intensity Therapeutics (INTS) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Intensity Therapeutics (INTS) has reported FDA regulatory activity for INT230-6.

The most recent FDA-related event for Intensity Therapeutics occurred on June 30, 2025, involving INT230-6. The update was categorized as "Provided Update," with the company reporting: "Intensity Therapeutics, Inc. announces that INT230-6 achieved complete responses in a murine models of Malignant Peripheral Nerve Sheath Tumor ("MPNST")."

Currently, Intensity Therapeutics has one therapy (INT230-6) targeting the following condition: treatment for certain soft tissue sarcoma subtypes..

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