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Gain Therapeutics (GANX) FDA Events

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FDA Events for Gain Therapeutics (GANX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Gain Therapeutics (GANX). Over the past two years, Gain Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as GT-02287 and GT-02287. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Gain Therapeutics' Drugs in FDA Review

GT-02287 - FDA Regulatory Timeline and Events

GT-02287 is a drug developed by Gain Therapeutics for the following indication: For Parkinson 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.

GT-02287 + GT-02329 - FDA Regulatory Timeline and Events

GT-02287 + GT-02329 is a drug developed by Gain Therapeutics for the following indication: Gaucher and GBA1 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.

Gain 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, Gain Therapeutics (GANX) has reported FDA regulatory activity for the following drugs: GT-02287 and GT-02287 + GT-02329.

The most recent FDA-related event for Gain Therapeutics occurred on May 29, 2025, involving GT-02287. The update was categorized as "Oral presentation," with the company reporting: "Gain Therapeutics, Inc. announced an oral presentation at the GBA1 Meeting 2025, being held June 5th-7th in Montreal, Canada."

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

  • For Parkinson Disease - GT-02287
  • Gaucher and GBA1 Parkinson's Disease - GT-02287 + GT-02329

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