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Coya Therapeutics Initiates ALS Trial Open-Label Extension
Coya Therapeutics announced plans to initiate an open-label extension, OLE, of the Phase 2/3 ALSTARS Trial evaluating COYA 302 for the treatment of amyotrophic lateral sclerosis. Coya plans to initiate the OLE in response to requests from ALSTARS investigators and study participants. The OLE will provide participants who complete the 48-week treatment period with the opportunity to continue receiving COYA 302, while enabling the collection of longer-term efficacy and safety data. Coya expects the OLE to begin in November 2026 as the first cohort completes the 48-week treatment period.
Coya Therapeutics Publishes Preclinical Results for COYA 303
Coya Therapeutics announced the publication of preclinical results for COYA 303 in the International Journal of Molecular Sciences. The article was published as part of the Special Issue, "The Roles of Glucagon-Like Peptide-1 Receptor Agonists in Health and Disease," which highlights the expanding therapeutic applications of GLP-1 receptor agonists across diverse disease settings, including their emerging immunomodulatory effects. COYA 303 is a combination of proprietary low-dose IL-2 and a GLP-1 receptor agonist, and was evaluated in a subacute low-dose lipopolysaccharide mouse model. The LPS mouse model recapitulates key features relevant to neurodegenerative diseases, including increased pro-inflammatory signaling and myeloid activation, leading to immune dysregulation, providing a validated setting for testing potential therapeutic interventions. The study evaluated whether simultaneously attenuating inflammatory myeloid activity and reinforcing Treg-mediated immune regulation could produce broader immunomodulatory effects than either approach alone.
Coya Reports Q2 Revenue of $243.7K, Exceeds Consensus
Reports Q2 revenue $243.7k, consensus $104.29k. "During the second quarter, we made notable progress advancing our lead program, COYA 302," said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya. "Enrollment in the ALSTARS Phase 2 ALS trial is proceeding as planned, and we remain on track to complete enrollment this year and report topline data in the first quarter of 2027. At the same time, we plan to initiate a Phase 2 study of COYA 302 in frontotemporal dementia in the coming months. Together, these programs reflect our differentiated strategy of applying Treg biology to address the shared mechanisms of these neurodegenerative conditions."
Coya Reports Q1 Revenue of $251,147
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 Receives FDA Fast Track Designation for COYA 302
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."
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