Satellos Bioscience (MSLE) FDA Approvals $6.40 -0.55 (-7.97%) As of 02:03 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Share Share FDA Events Stock AnalysisAnalyst ForecastsChartEarningsFDA EventsHeadlinesSEC FilingsShort InterestTrendsBuy This Stock Satellos Bioscience's Drug in the FDA Approval ProcessThis 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. Interim Data - March 10,2026Interim Data Drug: SAT-3247Announced Date: March 10, 2026Indication: Duchenne muscular dystrophy (DMD) AnnouncementSatellos Bioscience Inc. announced interim clinical and biomarker data for SAT-3247 at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.AI SummarySatellos 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 Satellos Bioscience FDA Events - Frequently Asked Questions Has Satellos Bioscience received FDA approval? As of now, Satellos Bioscience (MSLE) has not received any FDA approvals for its therapy in the last two years. What drugs has Satellos Bioscience submitted to the FDA? In the past two years, Satellos Bioscience (MSLE) has reported FDA regulatory activity for SAT-3247. What is the most recent FDA event for Satellos Bioscience? 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." What conditions do Satellos Bioscience's current drugs treat? Currently, Satellos Bioscience has one therapy (SAT-3247) targeting the following condition: Duchenne muscular dystrophy (DMD). More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events argenex FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA EventsIDEAYA Biosciences FDA EventsLexicon Pharmaceuticals FDA EventsMannKind FDA EventsInsulet FDA EventsTG Therapeutics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson FDA EventsCandel Therapeutics FDA EventsCelcuity FDA Events 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MSLE last updated on 3/10/2026 by MarketBeat.com Staff. 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Interim Data - March 10,2026Interim Data Drug: SAT-3247Announced Date: March 10, 2026Indication: Duchenne muscular dystrophy (DMD) AnnouncementSatellos Bioscience Inc. announced interim clinical and biomarker data for SAT-3247 at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.AI SummarySatellos 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
