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Mereo BioPharma Group (MREO) FDA Approvals

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Mereo BioPharma Group's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Mereo BioPharma Group (MREO). Over the past two years, Mereo BioPharma Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as setrusumab and Vantictumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Setrusumab FDA Regulatory Events

Setrusumab is a drug developed by Mereo BioPharma Group for the following indication: For the treatment of Osteogenesis Imperfecta. 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.

Vantictumab FDA Regulatory Events

Vantictumab is a drug developed by Mereo BioPharma Group for the following indication: for Autosomal Dominant Osteopetrosis Type 2. 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.

Mereo BioPharma Group FDA Events - Frequently Asked Questions

In the past two years, Mereo BioPharma Group (MREO) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Mereo BioPharma Group (MREO) has reported FDA regulatory activity for the following drugs: Vantictumab and setrusumab.

The most recent FDA-related event for Mereo BioPharma Group occurred on August 19, 2025, involving Vantictumab. The update was categorized as "Provided Update," with the company reporting: "āshibio, a privately held, clinical-stage biotechnology company developing novel therapeutics for the treatment of bone and connective tissue disorders, today announced an exclusive licensing agreement with Mereo BioPharma for vantictumab for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare, debilitating bone disorder with no approved therapies."

Current therapies from Mereo BioPharma Group in review with the FDA target conditions such as:

  • for Autosomal Dominant Osteopetrosis Type 2 - Vantictumab
  • For the treatment of Osteogenesis Imperfecta - setrusumab

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:MREO) was last updated on 8/22/2025 by MarketBeat.com Staff
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