COYA News & Events

Reports Q1 revenue $251,147, consensus $71,670. "We are off to a strong start in 2026, building on the clinical and scientific progress achieved last year," said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. "The ALSTARS trial is now in full recruitment mode, and we maintain our guidance for a 1Q 2027 topline readout. With a solid foundation and balance sheet in place we are well positioned to deliver on our priorities for 2026."

Coya Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track Designation for COYA 302, a proprietary investigational biologic combination therapy with a dual mechanism of action, for the treatment of amyotrophic lateral sclerosis. The FDA Fast Track Designation is a program designed to facilitate and expedite the development and review of drugs and biologics intended to treat serious or life-threatening conditions. Its primary purpose is to ensure that promising new therapies reach patients as quickly as possible through several key regulatory advantages, which include more frequent FDA interactions, potential for rolling review, and eligibility for expedited programs such as Accelerated Approval and Priority Review. "We are pleased to announce that COYA 302 has received FDA Fast Track designation for the treatment of ALS," said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. "This recognition underscores the devastating nature of ALS and the urgent need for new therapies. At Coya, we remain fully committed to advancing our lead biologic candidate, COYA 302, through the regulatory process with the ultimate goal of delivering-pending FDA approval-a safe and effective treatment for patients living with ALS and their families."

Coya Therapeutics announces the publication of a research study led by Dr. David Beers and Dr. Stanley Appel at the Houston Methodist Neurological Institute. The study included the longitudinal measurement of well-characterized serum biomarkers of lipid peroxidation, systemic inflammation, and axonal injury, and the functional evaluation over time of 100 randomly selected patients with ALS. The study has been published in the peer-reviewed journal Annals of Clinical and Translational Neurology. "These findings demonstrate significant correlations between biomarkers of inflammation, oxidative stress, and axonal injury and survival in patients with ALS", said Dr. Fred Grossman, President and Chief Medical Officer of Coya. "In our ongoing ALSTARS trial, we are measuring NfL as a secondary endpoint, along with inflammation markers including 4-HNE and ox-LDL as exploratory endpoints. Together, these efforts will further inform the growing body of evidence supporting the role of inflammation in neurodegenerative diseases."

Coya Therapeutics announced that founder Howard Berman has stepped down as Executive Chairman and as a member of the Board, and that Mark Pavao has been appointed to the Board as an independent director. Berman became Executive Chairman in November 2024 as part of a planned CEO transition that established Arun Swaminathan, as the Company's CEO. Dr. Berman's departure from the Executive Chairman role was a contemplated next step in that process. Coya is also proud to announce that Mark H. Pavao is joining its Board, to fill the Board seat resulting from Dr. Berman's departure. Pavao has held senior leadership roles at Biotech Value Advisors, LLC, R-Pharm US and Bristol-Myers Squibb.