FDA Events for MicroStrategy (MSTR)
This section highlights FDA-related milestones and regulatory updates for drugs developed by MicroStrategy (MSTR).
Over the past two years, MicroStrategy has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MET-233i. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MET-233i - FDA Regulatory Timeline and Events
MET-233i is a drug developed by MicroStrategy 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.
- Drug:
- MET-233i
- Announced Date:
- June 9, 2025
- Indication:
- Amylin Candidate
Announcement
Metsera, Inc. announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long acting amylin analog engineered for class-leading durability, potency, and combinability with Metsera's fully-biased monthly GLP-1 receptor agonist candidate, MET-097i.
AI Summary
Metsera, Inc. announced positive topline results from its Phase 1 clinical trial of MET-233i, an ultra–long acting amylin analog engineered for superior durability, potency, and the ability to be combined with its monthly GLP-1 receptor agonist candidate, MET-097i. In the study, MET-233i produced up to an 8.4% placebo-subtracted weight loss by Day 36 and showed a 19‐day half-life, supporting the feasibility of once-monthly dosing both as a monotherapy and in combination with MET-097i.
The trial, which enrolled participants with overweight or obesity, also demonstrated dose-linear pharmacokinetics and a favorable safety profile with mostly mild side effects. These findings suggest that MET-233i could provide effective and convenient weight management and may pave the way for the first monthly GLP-1 and amylin combination therapy. Metsera plans to advance the clinical development of this innovative approach further.
Read Announcement
MicroStrategy FDA Events - Frequently Asked Questions
As of now, MicroStrategy (MSTR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, MicroStrategy (MSTR) has reported FDA regulatory activity for MET-233i.
The most recent FDA-related event for MicroStrategy occurred on June 9, 2025, involving MET-233i. The update was categorized as "Positive Data," with the company reporting: "Metsera, Inc. announced positive topline data from the Phase 1 clinical trial of MET-233i, an ultra-long acting amylin analog engineered for class-leading durability, potency, and combinability with Metsera's fully-biased monthly GLP-1 receptor agonist candidate, MET-097i."
Currently, MicroStrategy has one therapy (MET-233i) targeting the following condition: Amylin Candidate.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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 7/12/2025 by MarketBeat.com Staff
