Quantum Biopharma (QNTM) FDA Approvals $3.91 +0.06 (+1.56%) Closing price 04:00 PM EasternExtended Trading$4.00 +0.09 (+2.40%) As of 07:59 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 Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesOwnershipSEC FilingsTrendsBuy This Stock Quantum Biopharma's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Quantum Biopharma (QNTM). Over the past two years, Quantum Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Lucid-MS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Lucid-MS FDA Regulatory Timeline and Events Lucid-MS is a drug developed by Quantum Biopharma for the following indication: For people to gain back mobility lost with multiple sclerosis (MS). 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. Application Submitted - April 1,2026Application Submitted INDDrug: Lucid-MSAnnounced Date: April 1, 2026Indication: For people to gain back mobility lost with multiple sclerosis (MS). AnnouncementQuantum BioPharma Ltd announced that it has formally submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lucid-21-302 (Lucid-MS), its new drug candidate for the treatment of multiple sclerosis (MS).Read AnnouncementProvided Update - March 26,2026Provided Update Drug: Lucid-MSAnnounced Date: March 26, 2026Indication: For people to gain back mobility lost with multiple sclerosis (MS). AnnouncementQuantum BioPharma Ltd. announced the appointment of Dr. Salvatore Napoli, MD, as Principal Investigator for its planned Phase 2 clinical trial evaluating Lucid-21-302 (Lucid-MS), an investigational therapy being developed to target demyelination in Multiple Sclerosis (MS).AI SummaryQuantum BioPharma Ltd. announced the appointment of Dr. Salvatore Napoli, MD, as Principal Investigator for its planned Phase 2 clinical trial of Lucid-21-302 (Lucid-MS). As Principal Investigator, Dr. Napoli will lead the study team, oversee trial conduct, and help ensure the integrity of data and patient safety throughout the trial. Lucid-21-302, also called Lucid-MS, is an investigational therapy being developed to target demyelination in Multiple Sclerosis (MS). The Phase 2 study is intended to evaluate the treatment in people with MS to assess its safety and potential effectiveness against damage to the protective myelin sheath around nerve fibers. This appointment is a key step toward starting the Phase 2 trial. With Dr. Napoli in place, Quantum can move forward with planning site activities, patient enrollment, and data collection needed to determine whether Lucid-MS shows promise as a new approach to treating demyelination in MS. Read AnnouncementProvided Update - August 11,2025Provided Update Drug: Lucid-MSAnnounced Date: August 11, 2025Indication: For people to gain back mobility lost with multiple sclerosis (MS). AnnouncementQuantum BioPharma Ltd. announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS.AI SummaryQuantum BioPharma Ltd. announced via its subsidiary Huge Biopharma Australia Pty Ltd. that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to produce an oral formulation of Lucid-MS. This new formulation will be used in the company’s Phase 2 clinical trial to help people with multiple sclerosis regain mobility. Lucid-MS is a patented, first-in-class, non-immunomodulatory compound designed to protect nerve fibers by preventing demyelination, a key issue in MS. Over the past decade, animal studies have shown that Lucid-MS helps restore walking ability. The oral form, called Lucid-21-302, will now advance to human testing to evaluate safety and effectiveness. Dr. Andrzej Chruscinski, Vice-President of Scientific and Clinical Affairs, said the CDMO partnership is a crucial step as Quantum BioPharma prepares its Investigational New Drug application with the FDA and moves forward with the Phase 2 study.Read Announcement Quantum Biopharma FDA Events - Frequently Asked Questions Has Quantum Biopharma received FDA approval? As of now, Quantum Biopharma (QNTM) has not received any FDA approvals for its therapy in the last two years. What drugs has Quantum Biopharma submitted to the FDA? In the past two years, Quantum Biopharma (QNTM) has reported FDA regulatory activity for Lucid-MS. What is the most recent FDA event for Quantum Biopharma? The most recent FDA-related event for Quantum Biopharma occurred on April 1, 2026, involving Lucid-MS. The update was categorized as "Application Submitted," with the company reporting: "Quantum BioPharma Ltd announced that it has formally submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lucid-21-302 (Lucid-MS), its new drug candidate for the treatment of multiple sclerosis (MS)." What conditions do Quantum Biopharma's current drugs treat? Currently, Quantum Biopharma has one therapy (Lucid-MS) targeting the following condition: For people to gain back mobility lost with multiple sclerosis (MS).. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Cybin FDA EventsREGENXBIO FDA EventsViking Therapeutics FDA EventsWAVE Life Sciences FDA EventsMerck & Co., Inc. FDA EventsAgomAb Therapeutics FDA EventsAmylyx Pharmaceuticals FDA EventsCoherus Oncology FDA EventsDiaMedica Therapeutics FDA EventsEntera Bio FDA EventsGalectin Therapeutics FDA EventsGilead Sciences FDA EventsJaguar Animal Health FDA EventsKalaris Therapeutics FDA EventsMicrobot Medical 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 Related Companies Alaunos Therapeutics FDA Events Xilio Therapeutics FDA Events Prima BioMed FDA Events Seres Therapeutics FDA Events Instil Bio FDA Events Edesa Biotech FDA Events Dogwood Therapeutics FDA Events KALA BIO FDA Events Actuate Therapeutics FDA Events Mereo BioPharma Group FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:QNTM last updated on 4/1/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersFirm That Predicted 2008, 2020, 2022: Right Now Looks WorseThe firm that predicted the dot-com crash, the 2008 financial crisis, the 2020 COVID crash, and the 2022 bear ...TradeSmith | SponsoredThe Treasury just bought its own debtOn April 16th, the U.S. Treasury executed a $15 billion buyback of its own debt - the largest in history - whi...Golden Portfolio | 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 | 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 | SponsoredElon Is Quietly Doubling Down on This Bizarre AssetYahoo Finance reports this technology 'May Unlock $400 Trillion' - and Bloomberg calls it 'unavoidable.' Elon ...Brownstone Research | SponsoredPH: Do THESE 4 things to your bank account now …In a few short months, the US government could gain unprecedented powers over personal bank accounts - includi...Weiss Ratings | SponsoredMy feud with Zohran MamdaniNearly 40% of Americans now hold a positive view of socialism - and former hedge fund manager Whitney Tilson s...Stansberry Research | SponsoredQuick favor to ask youBill Poulos is giving away his 'Safe Trade Options Formula' book at no charge - the same book that sells for $...Profits Run | 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 Quantum Biopharma Ltd. Please log in to your account or sign up in order to add this asset to your watchlist. Share Quantum Biopharma 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.
Application Submitted - April 1,2026Application Submitted INDDrug: Lucid-MSAnnounced Date: April 1, 2026Indication: For people to gain back mobility lost with multiple sclerosis (MS). AnnouncementQuantum BioPharma Ltd announced that it has formally submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lucid-21-302 (Lucid-MS), its new drug candidate for the treatment of multiple sclerosis (MS).Read Announcement
Provided Update - March 26,2026Provided Update Drug: Lucid-MSAnnounced Date: March 26, 2026Indication: For people to gain back mobility lost with multiple sclerosis (MS). AnnouncementQuantum BioPharma Ltd. announced the appointment of Dr. Salvatore Napoli, MD, as Principal Investigator for its planned Phase 2 clinical trial evaluating Lucid-21-302 (Lucid-MS), an investigational therapy being developed to target demyelination in Multiple Sclerosis (MS).AI SummaryQuantum BioPharma Ltd. announced the appointment of Dr. Salvatore Napoli, MD, as Principal Investigator for its planned Phase 2 clinical trial of Lucid-21-302 (Lucid-MS). As Principal Investigator, Dr. Napoli will lead the study team, oversee trial conduct, and help ensure the integrity of data and patient safety throughout the trial. Lucid-21-302, also called Lucid-MS, is an investigational therapy being developed to target demyelination in Multiple Sclerosis (MS). The Phase 2 study is intended to evaluate the treatment in people with MS to assess its safety and potential effectiveness against damage to the protective myelin sheath around nerve fibers. This appointment is a key step toward starting the Phase 2 trial. With Dr. Napoli in place, Quantum can move forward with planning site activities, patient enrollment, and data collection needed to determine whether Lucid-MS shows promise as a new approach to treating demyelination in MS. Read Announcement
Provided Update - August 11,2025Provided Update Drug: Lucid-MSAnnounced Date: August 11, 2025Indication: For people to gain back mobility lost with multiple sclerosis (MS). AnnouncementQuantum BioPharma Ltd. announces through its subsidiary, Huge Biopharma Australia Pty Ltd., that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to manufacture an oral drug formulation of Lucid-MS.AI SummaryQuantum BioPharma Ltd. announced via its subsidiary Huge Biopharma Australia Pty Ltd. that it has signed an agreement with a leading contract development and manufacturing organization (CDMO) to produce an oral formulation of Lucid-MS. This new formulation will be used in the company’s Phase 2 clinical trial to help people with multiple sclerosis regain mobility. Lucid-MS is a patented, first-in-class, non-immunomodulatory compound designed to protect nerve fibers by preventing demyelination, a key issue in MS. Over the past decade, animal studies have shown that Lucid-MS helps restore walking ability. The oral form, called Lucid-21-302, will now advance to human testing to evaluate safety and effectiveness. Dr. Andrzej Chruscinski, Vice-President of Scientific and Clinical Affairs, said the CDMO partnership is a crucial step as Quantum BioPharma prepares its Investigational New Drug application with the FDA and moves forward with the Phase 2 study.Read Announcement
