Curated News
By: NewsRamp Editorial Staff
September 10, 2026
Quantum BioPharma Advances Lucid-MS Toward Phase 2 MS Trial After FDA Clearance
TLDR
- Quantum BioPharma gains FDA IND clearance for Lucid-MS, advancing a first-in-class MS therapy toward phase 2 trials ahead of competitors.
- Lucid-MS is a non-covalent PAD2 inhibitor that targets demyelination directly, with a phase 2 trial planned after FDA IND clearance.
- Quantum BioPharma's Lucid-MS aims to reverse myelin damage in multiple sclerosis, offering new hope for patients with this debilitating disease.
- Quantum BioPharma collaborates with Harvard and MGH to use a PET tracer for visualizing demyelination in multiple sclerosis research.
Impact - Why it Matters
This news matters because it signals a potential paradigm shift in multiple sclerosis treatment. Current MS therapies largely rely on immunosuppression, which can leave patients vulnerable to infections and other complications. Lucid-MS takes a different approach by targeting demyelination directly, aiming to prevent and reverse myelin degradation—the underlying mechanism of MS. If successful in clinical trials, this first-in-class PAD2 inhibitor could offer a much-needed alternative for patients who do not respond adequately to existing treatments or who seek to avoid long-term immune suppression. The FDA's clearance of the IND application is a critical milestone that allows Quantum BioPharma to proceed with human testing, bringing this innovative therapy one step closer to patients. Additionally, the collaboration with Massachusetts General Hospital and Harvard Medical School on the [¹⁸F]3F4AP PET imaging tracer could provide researchers with a powerful new tool to visualize and measure demyelination, potentially accelerating drug development across the entire MS field. For investors, this progress validates Quantum BioPharma's pipeline and could drive future value, while for patients and healthcare providers, it represents hope for more effective and better-tolerated treatments. The broader context of other companies advancing therapies in areas of unmet need underscores the biotech industry's commitment to tackling some of the most challenging diseases.
Summary
Quantum BioPharma (NASDAQ: QNTM) (CSE: QNTM) is advancing its lead drug candidate, Lucid-MS, toward a randomized, double-blind, placebo-controlled phase 2 trial in multiple sclerosis (MS) after the U.S. Food and Drug Administration cleared its Investigational New Drug application. Lucid-MS is a patented, first-in-class, non-covalent inhibitor of peptidyl arginine deiminase 2 (PAD2), designed to target demyelination directly rather than suppressing the immune system. The company also highlighted a research collaboration with Massachusetts General Hospital and Harvard Medical School involving the [¹⁸F]3F4AP PET imaging tracer, which is being evaluated to visualize and measure demyelination. This news was disseminated on behalf of Quantum BioPharma Ltd. and may include paid advertising.
The update places Quantum BioPharma alongside other companies advancing therapies in areas of unmet medical need. Novartis AG received FDA approval for Pluvicto in combination with an androgen receptor pathway inhibitor for certain patients with metastatic hormone-sensitive prostate cancer. Merck & Co. Inc. had its supplemental Biologics License Application for ENFLONSIA accepted by the FDA to expand its indication for certain children at increased risk for severe respiratory syncytial virus disease. TG Therapeutics Inc. initiated a phase 2 trial of BRIUMVI in adults with treatment-resistant schizophrenia, and Bristol-Myers Squibb Company reported positive phase 2 results from the registrational QUINTESSENTIAL trial evaluating arlocabtagene autoleucel in heavily pretreated relapsed and refractory multiple myeloma. The full press release is available at https://ibn.fm/lCey9.
Quantum BioPharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for challenging neurodegenerative and metabolic disorders and alcohol misuse disorders. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc., Quantum focuses on Lucid-MS, a patented new chemical entity shown to prevent and reverse myelin degradation in preclinical models. Quantum also invented UNBUZZD and spun out its OTC version to Unbuzzd Wellness Inc., retaining a 19.84% ownership stake as of March 31, 2026, and royalty payments of 7% of sales until payments total $250 million, after which the royalty drops to 3% in perpetuity. The latest news and updates relating to QNTM are available in the company’s newsroom at https://ibn.fm/QNTM.
Source Statement
This curated news summary relied on content distributed by InvestorBrandNetwork (IBN). Read the original source here, Quantum BioPharma Advances Lucid-MS Toward Phase 2 MS Trial After FDA Clearance
