Press Releases September 11, 2026 08:30 AM

Quantum BioPharma Ltd. (NASDAQ: QNTM) Filling Key Gap in MS Treatment, Cleared by FDA to Launch Historic Trials

Quantum BioPharma receives FDA clearance to launch phase 2 trial for pioneering MS treatment Lucid-MS.

By Maya Rios
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Quantum BioPharma Ltd., trading on NASDAQ as QNTM, announced FDA clearance to initiate phase 2 clinical trials of Lucid-MS, an innovative first-in-class drug candidate aimed at protecting and potentially repairing the myelin sheath in multiple sclerosis patients. The drug represents a novel approach distinct from existing treatments by attempting to rebuild lost function rather than just slowing disease progression. This milestone is the first of its kind and has attracted positive attention from Wall Street analysts, signaling potential impact in biotech and neurodegenerative therapeutic markets.

Quantum BioPharma Ltd. (NASDAQ: QNTM) Filling Key Gap in MS Treatment, Cleared by FDA to Launch Historic Trials
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Key Points

  • Quantum announces FDA clearance for phase 2 clinical trial of Lucid-MS, targeting myelin repair in MS patients.
  • Lucid-MS is a novel therapeutic candidate that aims to reverse myelin degradation rather than just slow MS progression.
  • The clinical trial marks the first testing of this mechanism in humans, filling a significant gap in MS treatment options.

NEW YORK, Sept. 11, 2026 (GLOBE NEWSWIRE) -- via BioMedWire — Quantum BioPharma Ltd. (NASDAQ: QNTM) today announces its placement in an editorial published by BioMedWire (BMW), one of 75+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community.

To view the full publication, “Historic First in MS Treatment Could Reshape a Multibillion-Dollar Therapeutics Market,” please visit: https://ibn.fm/HOCTP

Today’s multiple sclerosis (“MS”) treatments can slow down disease progression, but none of them halt it outright, and none give back the function patients have already lost. Close to a million people in the United States, and nearly 2.9 million worldwide, live with that reality, watching a condition that steadily chips away at mobility, eyesight and basic physical control.

That gap in treatment options just picked up a serious new contender. Quantum BioPharma Ltd. has received U.S. Food and Drug Administration (“FDA”) clearance to launch a phase 2 trial of Lucid-MS, a patented, first-in-class candidate designed not to calm the immune system but to shield, and potentially rebuild, the myelin sheath itself. The clearance sets up what would be the first time in history that a drug built on this exact mechanism gets tested in people living with MS, a milestone significant enough that it has already drawn a fresh buy rating from Wall Street analysts. 

About Quantum BioPharma Ltd.

Quantum is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc., Quantum is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum invented UNBUZZD(TM) and spun out its OTC version to a company, Unbuzzd Wellness Inc. (“Unbuzzd”) (formerly Celly Nutrition Corp.), led by industry veterans. Quantum retains ownership of 19.84% (as of March 31, 2026) of Unbuzzd at www.unbuzzd.com. The agreement with Unbuzzd also includes royalty payments of 7% of sales from unbuzzd(TM) until payments to Quantum total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses.

For further information, please visit the company’s website at www.QuantumBioPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to QNTM are available in the company’s newsroom at https://ibn.fm/QNTM

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

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This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements.

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Risks

  • Lucid-MS is still in early stage clinical trials and may face hurdles in proving efficacy and safety, impacting investment and development prospects.
  • Regulatory outcomes beyond phase 2 remain uncertain, and failure to meet endpoints could adversely affect the stock.
  • Competition from existing and emerging MS therapies presents ongoing market and adoption risks.

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