Satellos Bioscience's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Satellos Bioscience (MSLE).
Over the past two years, Satellos Bioscience has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SAT-3247. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SAT-3247 FDA Regulatory Events
SAT-3247 is a drug developed by Satellos Bioscience for the following indication: Duchenne muscular dystrophy (DMD).
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:
- SAT-3247
- Announced Date:
- March 10, 2026
- Indication:
- Duchenne muscular dystrophy (DMD)
Announcement
Satellos Bioscience Inc. announced interim clinical and biomarker data for SAT-3247 at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.
AI Summary
Satellos Bioscience presented interim clinical and biomarker data for SAT-3247 at the Muscular Dystrophy Association conference in Orlando. In the ongoing Phase 2 TRAILHEAD study, investigators saw a continued increase in handgrip strength versus the CL-101 baseline, overall stability in elbow and shoulder strength at Day 56 after re-enrollment, and larger strength gains in participants who had greater baseline muscle mass. Additional clinical outcome assessments are ongoing.
A serum proteomic analysis from the completed 28‑day CL-101 Phase 1a/b trial evaluated over 11,000 proteins and showed consistent changes after two weeks of SAT-3247. Notable reductions were seen in established DMD biomarkers including AK1, CA3, ENO3, MB and ANKRD2, with similar magnitudes of change across participants. Satellos also described a new Regeneration Index based on known biomarkers to assess muscle regeneration, which will be used in the BASECAMP pediatric study. Preclinical data in a mouse FSHD model showed significant muscle-strength improvement over 12 weeks, suggesting potential use beyond DMD.
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Satellos Bioscience FDA Events - Frequently Asked Questions
As of now, Satellos Bioscience (MSLE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Satellos Bioscience (MSLE) has reported FDA regulatory activity for SAT-3247.
The most recent FDA-related event for Satellos Bioscience occurred on March 10, 2026, involving SAT-3247. The update was categorized as "Interim Data," with the company reporting: "Satellos Bioscience Inc. announced interim clinical and biomarker data for SAT-3247 at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida."
Currently, Satellos Bioscience has one therapy (SAT-3247) targeting the following condition: Duchenne muscular dystrophy (DMD).
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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
FDA progress for NASDAQ:MSLE last updated on 3/10/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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