Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi)

AUSTIN, Texas, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis (“MS”) drugs on the market today can slow the disease down, but none of them stop it, and none of them give patients back what they have already lost. Nearly one million people in the United States, and close to 2.9 million worldwide, live with that reality, watching a disease that can gradually erode mobility, vision, and basic bodily control. That gap has just gotten a serious new challenger. Quantum BioPharma Ltd. (NASDAQ: QNTM) (profile) has received FDA clearance to begin a phase 2 trial of Lucid-MS, a patented, first-in-class drug candidate aimed not at calming the immune system but at protecting and potentially repairing the myelin sheath itself. The clearance sets the stage for what would be the first time in history that a drug candidate built on this specific mechanism is tested in people living with the MS disease, a milestone significant enough that it has already drawn a fresh buy rating from Wall Street analysts. This momentum places Quantum BioPharma solidly in a group of leading companies focused on the treatment of serious diseases and areas of significant unmet medical need across vaccines, ophthalmology and neurological disease, including Sanofi (NASDAQ: SNY), Roche Holding AG (OTCQX: RHHBY), Biogen Inc. (NASDAQ: BIIB) and Clene Inc. (NASDAQ: CLNN). Research indicates that MS affects an estimated one million people in the United States and approximately 2.9 million people worldwide. The FDA's clearance of Quantum BioPharma's Investigational New Drug (“IND”) application marks a genuinely rare moment in MS research.In addition to the upcoming phase 2 drug trial, Quantum BioPharma has spent more than a year building a parallel research partnership with scientists at Massachusetts General Hospital (“MGH”) and Harvard Medical School. Lucid-MS, also known by its research designation Lucid-21-302, is built around a different theory of how to target MS progression. Clinical milestones matter to patients, but they also move markets, and Quantum BioPharma has recently drawn fresh attention from Wall Street analysts. Click here to view the custom infographic of the Quantum BioPharma editorial. A Disease That Takes Away Control Research indicates that MS affects an estimated one million people in the United States and approximately 2.9 million people worldwide. The disease occurs when a person's own immune system attacks myelin, the protective coating around nerve fibers that allows the brain to communicate with the rest of the body. Most people are diagnosed in their twenties or thirties, and women are affected roughly twice as often as men. Living with MS often means facing an unpredictable erosion of physical ability. Symptoms include fatigue, vision loss, numbness, and problems with balance and coordination. Over time many patients gradually lose fine motor control, mobility, and even bladder and bowel function. In addition, many people with MS end up managing a complicated mix of medications just to control symptoms alongside their core treatment, adding another daily burden on top of the disease itself. Nearly every currently approved MS therapy works by suppressing or modulating the immune system rather than directly protecting nerve tissue. Interferons, glatiramer acetate and newer monoclonal antibodies can reduce the frequency of relapses, and research confirms these drugs help many relapsing patients. But that same research shows the approach has real limits, since roughly one-half of patients on injectable immunomodulatory therapies stop taking them within the first year, and progressive forms of the disease remain especially hard to treat. Even large, well-funded competitors are still searching for something better. Several major pharmaceutical companies have advanced new MS candidates through late-stage trials in recent years only to see mixed or disappointing results, including recent failures in the broader field of myelin repair. That track record underscores how difficult it remains to develop a therapy that changes the disease's underlying course rather than just its symptoms. For patients, that means the wait for something that restores lost function, rather than merely slowing its loss, continues. A Historic First Human MS Test of a New Approach The FDA's clearance of Quantum BioPharma's Investigational New Drug (“IND”) application marks a genuinely rare moment in MS research. According to the company, the IND submission ran approximately 15,000 pages and includes a comprehensive package of pharmacology, toxicology and manufacturing data. With that clearance now secured, Quantum BioPharma can move directly into a randomized, double-blind, placebo-controlled phase 2 trial testing Lucid-MS in people suffering with MS. What makes this trial historic is the mechanism being tested on human patients with MS for the first time. Lucid-MS is a novel, first-in-class, non-covalent inhibitor of an enzyme called peptidyl arginine deiminase 2, or PAD2, that works by targeting demyelination rather than by suppressing the immune system. No FDA-approved MS therapy currently on the market has demonstrated the ability to prevent or reverse demyelination, and the broader field of remyelinating drug candidates has faced repeated setbacks. Quantum BioPharma's own CEO called the clearance a defining moment for the company. “FDA clearance to proceed with our Lucid-MS phase 2 trial is a transformative moment for Quantum and the result of years of dedicated scientific research,” stated Zeeshan Saeed, in the SEC filing. That filing also frames the trial within a global MS therapeutics market anticipated to reach approximately $38.62 billion by 2030. If Lucid-MS demonstrates in human patients what it has shown in preclinical models, the implications extend well beyond one company's pipeline. It would mark the first time a drug candidate targeting demyelination directly, rather than the immune system broadly, has shown in controlled human testing that it might help patients regain lost bodily control. That would represent a meaningfully different category of MS treatment than anything currently available to patients today. A Groundbreaking MS Imaging Collaboration In addition to the upcoming phase 2 drug trial, Quantum BioPharma has spent more than a year building a parallel research partnership with scientists at Massachusetts General Hospital (“MGH”) and Harvard Medical School. The focus of the research is solving a different but related problem: how to actually see demyelination happening in a living patient's brain. The collaboration centers on a novel PET imaging tracer called [¹⁸F]3F4AP. The tracer was developed by Dr. Pedro Brugarolas, an investigator in the Department of Radiology at MGH and assistant professor at Harvard Medical School, with Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and associate professor of Neurology at Harvard Medical School, serving as co-investigator. In June 2025, the first person with MS was scanned using a newly installed combined PET-MR scanner at MGH, allowing researchers to capture PET and MRI data simultaneously with improved precision.By August 2025, the collaboration had already produced peer-reviewed results. Findings published in the European Journal of Nuclear Medicine and Molecular Imaging and funded by the National Institutes of Health showed that [18F]3F4AP had excellent properties for imaging the human brain and could detect differences across lesions that were not visible on conventional MRI. The study reached a key midpoint milestone in May 2026, with Brugarolas noting that the ability to directly quantify demyelinated lesions with intact axons represents an important unmet need in MS research. If fully validated, this imaging approach could eventually give researchers a far more direct and quantitative way to measure myelin loss and repair than MRI alone currently allows. That matters well beyond Quantum BioPharma's own research and development, since a reliable biomarker for demyelination could help evaluate any future therapy aimed at protecting or restoring myelin, not just Lucid-MS. For now, the imaging study and the phase 2 drug trial run on separate, parallel tracks, with Quantum BioPharma also working with a global contract research organization with CNS and MS trial experience, to support the drug trial's site-selection and start-up activities. The Science Behind Lucid-MS Lucid-MS, also known by its research designation Lucid-21-302, is built around a different theory of how to target MS progression. Rather than treating the immune system as the primary target, the compound is designed to act on PAD2, an enzyme expressed in the central nervous system that catalyzes a chemical process called citrullination of myelin proteins. That citrullination process is believed to contribute directly to the breakdown of myelin, making PAD2 inhibition a plausible way to interrupt disease progression at its source. The compound is a patented new chemical entity that has been studied for more than 11 years, with underlying research published in peer-reviewed journals including the “Journal of Medicinal Chemistry” and the “Proceedings of the National Academy of Sciences.” In preclinical animal models, the company reports that Lucid-MS accelerated functional recovery, preserved myelin and reduced axonal degradation, all without suppressing the immune system, distinguishing its proposed mechanism from nearly every currently marketed MS drug. That non-immunomodulatory profile is central to the company's scientific pitch. Because Lucid-MS is not designed to broadly dampen immune activity, the goal is to avoid the infection risk and other systemic side effects that can accompany immunosuppressive MS therapies, while directly addressing the demyelination process believed to drive long-term disability. The compound is also designed for potential oral administration with a comparatively simple dosing regimen, which could offer a meaningful convenience advantage over injectable or infused competitors if it succeeds in later-stage trials. Before reaching this point, Lucid-MS completed phase 1 clinical trials in healthy human volunteers, with the company reporting a favorable safety profile and good tolerability in that earlier testing. Dr. Andrzej Chruscinski, VP of Scientific and Clinical Affairs at Quantum, has said the IND submission reflects years of dedicated scientific research characterizing the compound's safety profile. With the FDA clearance now secured, the upcoming phase 2 trial will be the first opportunity to see whether that mechanism, built on more than a decade of laboratory work, actually helps people with progressive MS regain lost function. Wall Street Takes Notice Clinical milestones matter to patients, but they also move markets, and Quantum BioPharma has recently drawn fresh attention from Wall Street analysts. Rodman & Renshaw just initiated coverage of the company with a Buy rating and an $8 price target. The firm's report describes Lucid-MS as a potentially first-in-class, non-immunomodulatory small molecule aimed at addressing neurodegeneration and disability progression in progressive MS, an area where therapeutic options remain limited. Rodman & Renshaw’s $8 price target reflects its valuation of Quantum BioPharma's overall development pipeline, anchored by the newly cleared phase 2 program. This initiation follows earlier unpaid coverage from Kingswood Capital Partners, which set a $45 price target in September 2025 based on a discounted cash flow model assuming successful phase 2 and phase 3 trials and a 2029 commercial launch. New analyst coverage matters for a clinical-stage biopharmaceutical company because it signals that outside experts, with no obligation to be optimistic, see enough evidence in the data to justify a formal recommendation. For a small-cap company preparing to enter a pivotal trial, that kind of third-party validation can help build the visibility and credibility needed to support the stock through a long and expensive testing process. It also gives investors a data point beyond the company's own announcements when weighing the risk and potential reward of the phase 2 program. Collectively, the FDA clearance and phase 2 studies, the Harvard-affiliated imaging collaboration and the new analyst coverage paint a picture of a company methodically building the pieces needed to test a genuinely different approach to multiple sclerosis. Quantum BioPharma is still a clinical-stage company, and like any drug candidate entering human trials, there are no guarantees of success. But few companies ever reach this point: Lucid-MS is now cleared for its first real test in people living with progressive MS, giving the company a genuine chance to show that protecting the myelin sheath directly can succeed where decades of immune-focused treatments have fallen short. Biotech Leaders Advance Next-Generation Therapies Innovation across the biopharmaceutical sector continues to accelerate as companies pursue new approaches to serious diseases and areas of significant unmet medical need. Recent developments spanning infectious-disease prevention, ophthalmology and neurological disease highlight the breadth of work underway. Sanofi (NASDAQ: SNY) announced that the European Commission (“EC”) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi was previously approved in the EU for use in individuals aged 12 months and older. The expanded indication follows the positive opinion adopted by the Committee for Medicinal Products for Human Use on June 25, 2026. Roche Holding AG (OTCQX: RHHBY) released new two-year data from the phase IIIb/IV SALWEEN study of Vabysmo(R) (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society (“APVRS”) Congress in Australia. The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (“PCV”), a severe subtype of neovascular age-related macular degeneration (“nAMD”), the leading cause of vision loss in people over the age of 60. Biogen Inc. (NASDAQ: BIIB) reported that the National Medical Products Administration (“NMPA”) of China has approved the subcutaneous formulation, the anti-amyloid beta (Aβ) protofibril antibody LEQEMBI(R), as an initiation treatment for mild cognitive impairment (“MCI”) due to Alzheimer’s disease (“AD”) or mild AD dementia, collectively referred to as early AD. The application was accepted by the NMPA in January 2026 and was subsequently granted Priority Review designation. Clene Inc. (NASDAQ: CLNN) shared results from new analyses examining clinical outcomes among CNM-Au8(R)-treated patients whose neurofilament light chain (“NfL”) biomarker levels declined or stabilized. These findings will be included in Clene’s planned New Drug Application (“NDA”) seeking accelerated approval and are intended to address the questions raised by the U.S. Food and Drug Administration (“FDA”) during a March 2026 Type C meeting. At that meeting, the FDA acknowledged that NfL, a recognized blood marker of nerve-cell injury, has established prognostic value in amyotrophic lateral sclerosis (“ALS”) and could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval. As established and emerging biopharmaceutical companies continue to advance new medicines and treatment strategies, developments across these diverse therapeutic areas underscore both the breadth of medical need and the opportunity for continued innovation. From disease prevention and vision preservation to new approaches for neurodegenerative disorders, these advances illustrate the range of scientific and regulatory progress taking place across the sector. 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