USFDAJun 1, 2026, 07:30 PM
Quantum BioPharma's Lucid-MS IND Placed on FDA Clinical Hold
AI Summary
Quantum BioPharma Ltd. announced that the U.S. Food and Drug Administration (FDA) placed its Investigational New Drug (IND) application for Lucid-21-302 (Lucid-MS), a drug candidate for multiple sclerosis, on clinical hold. The company received correspondence on May 28, 2026, requesting additional information. Quantum BioPharma believes the issues are addressable and plans to work with the FDA to submit a response, while also withdrawing all previously disclosed timelines for the program. Additionally, Dr. Lakshmi P. Kotra resigned as a director and from all positions, effective June 1, 2026, but will remain as a senior clinical advisor.
Key Highlights
- Quantum BioPharma's Investigational New Drug (IND) application for Lucid-21-302 (Lucid-MS) was placed on clinical hold by the FDA on May 28, 2026.
- The clinical hold is pending submission of additional information requested by the agency.
- Quantum BioPharma believes the issues raised by the FDA are addressable and plans to submit a response package.
- The company is withdrawing previously disclosed timelines for FDA review, Phase 2 trial initiation, and interim data milestones.
- Dr. Lakshmi P. Kotra resigned as director and from all positions at Quantum BioPharma and its subsidiaries, effective June 1, 2026.
- Dr. Kotra will continue to serve as a senior clinical advisor for Quantum BioPharma.
- Lucid-MS (Lucid-21-302) is a patented new chemical entity for the treatment of multiple sclerosis.
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