Quantum Biopharma's Drug in the FDA Approval Process
This 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.
- Drug:
- Lucid-MS
- Announced Date:
- April 1, 2026
- Indication:
- For people to gain back mobility lost with multiple sclerosis (MS).
Announcement
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).
Read Announcement- Drug:
- Lucid-MS
- Announced Date:
- March 26, 2026
- Indication:
- For people to gain back mobility lost with multiple sclerosis (MS).
Announcement
Quantum 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 Summary
Quantum 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- Drug:
- Lucid-MS
- Announced Date:
- August 11, 2025
- Indication:
- For people to gain back mobility lost with multiple sclerosis (MS).
Announcement
Quantum 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 Summary
Quantum 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
As of now, Quantum Biopharma (QNTM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Quantum Biopharma (QNTM) has reported FDA regulatory activity for Lucid-MS.
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)."
Currently, Quantum Biopharma has one therapy (Lucid-MS) targeting the following condition: For people to gain back mobility lost with multiple sclerosis (MS)..
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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
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.
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