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Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis

TORONTO, April 01, 2026 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FR...

articleQuantum Biopharma Ltd. Subordinate Voting Shares Class BApril 1, 20263/company/quantum-biopharma-ltd-ordinary-shares-class-b-sub-voting/news/quantum-biopharma-submits-investigational-new-drug-ind-application-to-united-states-food-and-drug-administration-fda-for-lucid-ms-phase-two-clinical-trial-in-multiple-sclerosis
Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis

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[{"type":"text","content":"Quantum BioPharma Submits Investigational New Drug (IND) Application to United States Food and Drug Administration (FDA) for Lucid-MS Phase Two Clinical Trial in Multiple Sclerosis\nTORONTO, April 01, 2026 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today 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). This milestone IND submission supports Quantum’s planned Phase 2 clinical trial evaluating its first-in-class therapeutic treatment targeting demyelination, advancing Quantum BioPharma’s strategic growth in the global neurological market. Milestone IND submission supports planned phase-2 clinical trial evaluating First-in-Class therapeutic treatment targeting demyelination to advance Quantum BioPharma’s strategic growth in global neurological market. This strategic milestone represents a significant advancement in Quantum BioPharma's clinical development pipeline and underscores the Company's commitment to delivering innovative therapeutic solutions for patients suffering from debilitating neurological conditions. Comprehensive IND Submission and Development Timeline The IND submission includes data from nonclinical pharmacology and toxicology studies, along with manufacturing and quality information, to support initiation of the planned Phase 2 clinical trial. Subject to FDA clearance, Quantum BioPharma intends to initiate the Phase 2 study as soon as possible. Phase 1 Clinical TrialsCompleted✓ Safe & Well-ToleratedIND Submission to FDAMarch 2026✓ SubmittedAnticipated FDA ResponseQ2 2026PendingPhase 2 Trial InitiationQ2 2026PlannedPhase 2 Interim DataQ4 2026Projected    First-in-Class Therapeutic Innovation Lucid-MS is designed to provide neuroprotection through the inhibition of demyelination—a key driver of disease progression in MS. This innovative mechanism represents a differentiated ther...

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