Quantum BioPharma gets FDA clearance for MS drug phase 2 trial

Quantum BioPharma Ltd. (NASDAQ: QNTM) has received clearance from the U.S. Food and Drug Administration to begin a phase 2 clinical trial of Lucid-MS, a drug candidate targeting multiple sclerosis, according to a statement from the company.

Lucid-MS is described as a patented, first-in-class compound designed to protect and potentially rebuild the myelin sheath, the protective coating around nerve fibers that deteriorates in MS patients. The drug's mechanism differs from existing MS treatments, which aim to slow immune system activity rather than address myelin directly.

Current MS therapies can slow disease progression but do not halt it or restore lost function. Approximately one million people in the United States and nearly 2.9 million worldwide live with the condition.

The FDA clearance allows Quantum BioPharma to proceed with testing Lucid-MS in human subjects for the first time. The company states this would mark the first clinical trial of a drug built on this specific mechanism for MS treatment.

Quantum BioPharma operates through its wholly owned subsidiary, Lucid Psycheceuticals Inc., which leads research and development of Lucid-MS. The company also holds a 19.84% stake in Unbuzzd Wellness Inc., as of March 31, 2026, and is entitled to royalty payments of 7% of that company's sales until payments reach $250 million, after which the royalty rate drops to 3% in perpetuity.

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