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Strategy (MSTR) FDA Approvals

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Strategy's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Strategy (MSTR). Over the past two years, Strategy has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MET-097i and MET-233i. 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.

MET-097i FDA Regulatory Events

MET-097i is a drug developed by Strategy for the following indication: GLP-1 RA Candidate. 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.

MET-233i FDA Regulatory Events

MET-233i is a drug developed by Strategy for the following indication: Amylin Candidate. 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.

Strategy FDA Events - Frequently Asked Questions

In the past two years, Strategy (MSTR) 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, Strategy (MSTR) has reported FDA regulatory activity for the following drugs: MET-097i and MET-233i.

The most recent FDA-related event for Strategy occurred on September 29, 2025, involving MET-097i. The update was categorized as "Top-line data," with the company reporting: "Metsera, Inc announced positive topline data from VESPER-1 and positive data from a planned interim analysis for tolerability of VESPER-3 – two Phase 2b trials of MET-097i, a first-in-class fully biased, ultra-long acting GLP-1 receptor agonist (RA) with potential for monthly dosing."

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

  • GLP-1 RA Candidate - MET-097i
  • Amylin Candidate - MET-233i

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:MSTR) was last updated on 10/1/2025 by MarketBeat.com Staff
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