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Altimmune (ALT) FDA Events

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FDA Events for Altimmune (ALT)

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

Altimmune's Drugs in FDA Review

pemvidutide - FDA Regulatory Timeline and Events

pemvidutide is a drug developed by Altimmune for the following indication: for the treatment of obesity and MASH. 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.

Pemvidutide (ALT-801) Obesity - FDA Regulatory Timeline and Events

Pemvidutide (ALT-801) Obesity is a drug developed by Altimmune for the following indication: Obesity. 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.

Altimmune FDA Events - Frequently Asked Questions

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

In the past two years, Altimmune (ALT) has reported FDA regulatory activity for the following drugs: pemvidutide and Pemvidutide (ALT-801) Obesity.

The most recent FDA-related event for Altimmune occurred on July 9, 2025, involving pemvidutide. The update was categorized as "Enrollment Update," with the company reporting: "Altimmune, Inc. announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD)."

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

  • for the treatment of obesity and MASH - pemvidutide
  • Obesity - Pemvidutide (ALT-801) Obesity

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:ALT) was last updated on 7/9/2025 by MarketBeat.com Staff
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