Satellos Bioscience (MSLE) FDA Approvals $6.71 +1.09 (+19.40%) Closing price 06/25/2026 04:00 PM EasternExtended Trading$6.75 +0.04 (+0.60%) As of 06/25/2026 07:24 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours 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 Agenus FDA EventsAtea Pharmaceuticals FDA EventsKymera Therapeutics FDA EventsLexaria Bioscience FDA EventsMIRA Pharmaceuticals FDA EventsPainReform FDA EventsProQR Therapeutics FDA EventsTiziana Life Sciences FDA EventsGlaukos FDA EventsMerck & Co., Inc. FDA EventsCybin FDA EventsIonis Pharmaceuticals FDA EventsREGENXBIO FDA EventsViking Therapeutics FDA EventsWAVE Life Sciences 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. We continuously monitor for new FDA events and market data. From Our PartnersSpaceX IPO “cancelled”?SpaceX is approaching what could be a $1.6 trillion IPO - potentially the largest in history. But Louis Navell...InvestorPlace | SponsoredBuy this stock todayMarc Chaikin, founder of Chaikin Analytics, is sharing a strategy he calls 'Sell This, Buy That' - a way to mo...Chaikin Analytics | SponsoredThe EPA just put a kill switch on Elon’s empireA federal EPA permit expires January 2, 2027 - and if Elon Musk's Colossus supercomputer loses power that day,...Behind the Markets | SponsoredDo NOT Buy SpaceX – Do This InsteadSpaceX just went public - and Whitney Tilson, Harvard MBA and 30-year Wall Street veteran, says buying in coul...Stansberry Research | SponsoredBlackRock is hoarding it. JPMorgan is hoarding it. Do you own it?BlackRock, JPMorgan, Goldman Sachs, and Fidelity are reportedly accumulating a scarce blockchain asset - one t...Awesomely, LLC | SponsoredGrab it and keep itSimple Options Trading For Beginners is currently available as a free download - a guide normally priced at $2...Profits Run | SponsoredMillionaire trader who went 13-for-13 on Trump in 2025 now turns his attention to Elon.Hedge fund trader Larry Benedict went 13-for-13 in Q1 2025 - not a single losing trade - and finished the year...Brownstone Research | SponsoredA letter from Shannon StansberryPorter Stansberry nearly canceled the entire project. When he first saw the claimed returns - only one down ye...Porter & Company | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Satellos Bioscience Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Satellos Bioscience With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
Free MSLE Stock Alerts