Welcome to our dedicated page for Coya Therapeutics news (Ticker: COYA), a resource for investors and traders seeking the latest updates and insights on Coya Therapeutics stock.
Coya Therapeutics, Inc. develops investigational biologics intended to enhance regulatory T-cell, or Treg, function in neurodegenerative disorders. Company news centers on COYA 302, including clinical and regulatory updates in amyotrophic lateral sclerosis and frontotemporal dementia, biomarker publications, and research on systemic inflammation, lipid peroxidation, axonal injury, and Treg dysfunction.
Coya updates also cover its Treg-focused therapeutic platforms, including Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Recurring business developments include collaboration activity with Dr. Reddy’s Laboratories, milestone-related revenue disclosures, operating results, stockholder communications, and board or governance changes.
Coya Therapeutics (NASDAQ: COYA) reported that the first cohort of ALS patients in the ALSTARS Trial has entered the 24-week blinded active-treatment extension, during which all participants receive COYA 302.
According to Coya, this design can provide up to 48 weeks of COYA 302 data in ALS.
Coya Therapeutics (NASDAQ: COYA) will present the design of its ongoing ALSTARS Phase 2 trial of COYA 302 at the 5th ALS Drug Development Summit in Boston, held June 2–4, 2026.
The poster, focused on targeting regulatory T cells and neuroinflammation in ALS, will be presented on June 3, 2026 at 4:45 PM ET by Senior Director of Clinical Development Tyrell Simkins, D.O., Ph.D.
Coya Therapeutics (NASDAQ: COYA) reported Q1 2026 financial results and clinical progress. Cash and equivalents were $50.7 million as of March 31, 2026. Collaboration revenue was $0.3 million. R&D expenses fell to $4.1 million, while G&A rose to $3.8 million. Net loss was $7.2 million.
The FDA granted Fast Track Designation to COYA 302 for ALS and accepted an IND for COYA 302 in frontotemporal dementia. Coya also closed an $11.1 million private placement and advanced its ALSTARS Phase 2 ALS trial and FTD program toward 2H 2026 milestones.
Coya Therapeutics (NASDAQ: COYA) announced that the U.S. FDA granted Fast Track Designation for COYA 302, a proprietary investigational biologic combination therapy with a dual mechanism of action, for treating amyotrophic lateral sclerosis (ALS).
The Fast Track program offers more frequent FDA interactions, potential rolling review, and eligibility for expedited pathways such as Accelerated Approval and Priority Review, supporting COYA 302’s development for this serious, life-threatening condition.
Coya Therapeutics (NASDAQ: COYA) announced publication of a longitudinal biomarker study in ALS showing correlations between serum 4-HNE, LBP, NfL and survival in 100 patients versus 100 controls.
All three markers were elevated in ALS; 4-HNE and LBP rose with progression (p < 0.001) and diagnosis levels of all three correlated with survival (p <= 0.001). A prior investigator-initiated trial of LD IL-2 + CTLA-4 Ig (n=4) showed biomarker reductions and stable ALSFRS-R over 48 weeks.
Coya Therapeutics (NASDAQ: COYA) announced that founder Howard Berman, Ph.D., has stepped down as Executive Chairman and from the Board, and that Mark H. Pavao has been appointed as an independent director. The move follows a CEO transition begun in November 2024 that established Arun Swaminathan, Ph.D., as CEO. The company highlighted Pavao’s >30 years of commercial experience and said COYA 302 is approaching an important Phase 2B ALSTARS data readout as the company advances toward potential commercialization.
ReAlta Life Sciences (NASDAQ:AVIR) appointed Howard Berman, Ph.D. as Chairman and CEO and Kia Motesharei, Ph.D. as President and COO on March 24, 2026.
The hires add capital markets, deal-making, and late-stage clinical development experience as ReAlta advances pegtarazimod into late-stage trials for HIE and other indications.
Coya Therapeutics (NASDAQ: COYA) highlighted a peer‑reviewed study showing peripheral immune dysregulation in frontotemporal dementia (FTD). Blood from 27 FTD patients and 25 controls showed significantly reduced Treg suppressive function (p<0.05) and elevated pro‑inflammatory mediators including TNFα and multiple chemokines (p<0.05–0.01).
Previously reported investigator data of low‑dose IL‑2 plus CTLA‑4 Ig showed increased Treg number/function within two weeks, no cognitive decline over 22 weeks, and favorable tolerability.
Coya Therapeutics (NASDAQ: COYA) reported FY2025 results and a corporate update highlighting clinical and financial progress. Key milestones include IND acceptance for COYA 302 in FTD, ALSTARS Phase 2 launch with ~25 U.S./Canada sites, a U.S. patent for an RTU IL-2 formulation, and cash of $46.8M with financing extending runway into 2H 2027.
FY2025 revenue included $7.9M collaboration revenue and $6.7M license revenue; net loss was $21.2M.
Coya Therapeutics (NASDAQ: COYA) will host a live webinar on February 17, 2026 at 3:00 p.m. ET / 12:00 p.m. PT titled “Inside the Evolving ALS Landscape: Biology, Innovation, and Clinical Progress.”
The event will review ALS biology, recent treatment advances, and patient needs, highlight Coya’s immunotherapy combination COYA 302, and provide an overview of the ALSTARS Phase 2 clinical trial design and enrollment. Fred Grossman, D.O., FAPA, will moderate with experts Stanley Appel, M.D., and James Berry, M.D., MPH. Pre-registration is open, attendees may submit written Q&A, and a recording will be posted to the company website.