Quantum Biopharma (QNTM) FDA Approvals $4.48 -0.40 (-8.20%) Closing price 04:00 PM EasternExtended Trading$4.48 0.00 (-0.02%) As of 06:45 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 FilingsShort InterestTrendsBuy 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 Axsome Therapeutics FDA EventsBiogen FDA EventsFate Therapeutics FDA EventsGH Research FDA EventsIncyte FDA EventsJazz Pharmaceuticals FDA EventsMoleculin Biotech FDA EventsMirum Pharmaceuticals FDA EventsNextCure FDA EventsPharming Group FDA EventsRegeneron Pharmaceuticals FDA Eventsargenex FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics 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 Spruce Biosciences FDA Events Indaptus Therapeutics FDA Events vTv Therapeutics FDA Events Rani Therapeutics FDA Events Black Diamond Therapeutics FDA Events Cypherpunk Technologies FDA Events Pyxis Oncology FDA Events Cardiff Oncology FDA Events Polaryx Therapeutics FDA Events Kalaris Therapeutics 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. 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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
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