Free Trial

4D Molecular Therapeutics (FDMT) FDA Events

4D Molecular Therapeutics logo
$4.42 +0.20 (+4.74%)
As of 04:00 PM Eastern
FDA Events for 4D Molecular Therapeutics (FDMT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by 4D Molecular Therapeutics (FDMT). Over the past two years, 4D Molecular Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as 4D-150, 4D-175, and 4D-710. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

4D Molecular Therapeutics' Drugs in FDA Review

4D-150 - FDA Regulatory Timeline and Events

4D-150 is a drug developed by 4D Molecular Therapeutics for the following indication: Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi. 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.

4D-175 - FDA Regulatory Timeline and Events

4D-175 is a drug developed by 4D Molecular Therapeutics for the following indication: For the Treatment of Geographic Atrophy. 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.

4D-710 - FDA Regulatory Timeline and Events

4D-710 is a drug developed by 4D Molecular Therapeutics for the following indication: Cystic fibrosis lung 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.

4D Molecular 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, 4D Molecular Therapeutics (FDMT) has reported FDA regulatory activity for the following drugs: 4D-150, 4D-175 and 4D-710.

The most recent FDA-related event for 4D Molecular Therapeutics occurred on July 2, 2025, involving 4D-150. The update was categorized as "Provided Update," with the company reporting: "4D Molecular Therapeutics announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet age-related macular degeneration (wet AMD)."

Current therapies from 4D Molecular Therapeutics in review with the FDA target conditions such as:

  • Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi. - 4D-150
  • For the Treatment of Geographic Atrophy - 4D-175
  • Cystic fibrosis lung disease - 4D-710

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:FDMT) was last updated on 7/9/2025 by MarketBeat.com Staff
From Our Partners