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
forazapadin and SAT-3247. 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.
Forazapadin FDA Regulatory Events
Forazapadin is a drug developed by Satellos Bioscience for the following indication: for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
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:
- forazapadin
- Announced Date:
- September 30, 2026
- Indication:
- for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
Announcement
Satellos Bioscience Inc. announced that enrollment has been completed for BASECAMP, the company’s Phase 2 clinical trial evaluating forazapadin for the treatment of Duchenne muscular dystrophy (DMD) in ambulatory boys 7 to 10 years of age.
Read Announcement- Drug:
- forazapadin
- Announced Date:
- September 24, 2026
- Indication:
- for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
Announcement
Satellos Bioscience Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for forazapadin for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
Read Announcement
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:
- June 29, 2026
- Indication:
- Duchenne muscular dystrophy (DMD)
Announcement
Satellos Bioscience Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SAT-3247 for the treatment of Duchenne.
AI Summary
Satellos Bioscience Inc. said the U.S. Food and Drug Administration has granted Fast Track designation to SAT-3247 for the treatment of Duchenne muscular dystrophy. Fast Track is meant to speed the development and review of medicines for serious diseases that still have unmet medical needs. This designation may give the company more frequent meetings with the FDA, allow parts of a future application to be reviewed as they are completed, and could also support Priority Review or Accelerated Approval if the drug meets the required standards.
The company is currently studying SAT-3247 in its Phase 2 BASECAMP and TRAILHEAD trials, which include both children and adults living with Duchenne. Satellos says the designation is an important step as it works to advance the program and address this serious condition.
Read Announcement- 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.
Read Announcement
