QNTM News & Events

Quantum BioPharma announced that it has formally submitted an investigational new drug application to the FDA for Lucid-21-302, its new drug candidate for the treatment of multiple sclerosis.

Quantum BioPharma announced that it has entered into a binding letter of intent with Allucent to support the planned Phase 2 clinical trial of Lucid-MS for the treatment of multiple sclerosis. The planned Phase 2 trial will evaluate the efficacy, safety and tolerability of Lucid-MS in people with MS. Quantum BioPharma expects to initiate the Phase 2 trial in the second quarter of 2026, subject to regulatory approvals and finalization of the clinical trial design and operational arrangements. Under the terms of the LOI, Allucent will provide comprehensive clinical trial services designed to support efficient execution and data integrity throughout the study.

Quantum BioPharma announces that oral dosing of Lucid-21-302, Lucid-MS, is complete in both the 180-day toxicity and toxicokinetic studies. These studies will support the Investigational New Drug, IND, application with the US FDA, including the design of a Phase 2 trial of Lucid-MS in people with multiple sclerosis, MS. Anthony Durkacz, Founder and executive co-chairman of Quantum BioPharma added, "By completing these 180-day toxicity studies, we are now two important steps closer to initiating the Phase 2 trial of Lucid-MS in people with multiple sclerosis. We are very excited about the potential of this new, first-in-class treatment to prevent disease progression and inhibit demyelination in MS."

Quantum BioPharma understands that Quantum BioPharma shareholder Paul Durkacz has filed a class action lawsuit alleging that investors in Quantum BioPharma were the victims of stock manipulation. The suit alleges that between January 6, 2021, and October 15, 2025, shareholders who sold securities of Quantum Biopharma Ltd., formerly known as FSD Pharma Inc., were significantly and materially harmed.