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 (COYA) has enrolled the 100th participant in its ongoing Phase 2/3 ALSTARS trial of COYA 302 for amyotrophic lateral sclerosis (ALS), keeping the study on track for topline results in early Q2 2027.
The trial is evaluating COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig designed to enhance T‑cell (Treg) function in patients with neurodegenerative disorders. Based on current screening and enrollment rates, the company expects to complete full enrollment of 120 participants in the coming weeks, which would support the planned early Q2 2027 topline data readout. Additional participants are continuing to roll over into the active extension arm of the study, and COYA 302 has received FDA Fast Track designation for the treatment of ALS.
Coya Therapeutics (COYA) reported publication of preclinical data on COYA 303, a combination of proprietary low-dose IL-2 (LD‑IL2) and a GLP‑1 receptor agonist (GLP‑1RA), in the International Journal of Molecular Sciences.
In a subacute low-dose LPS mouse model of peripheral and CNS inflammation, the combination therapy showed complementary immunomodulatory effects versus either component alone. Peripherally, COYA 303 significantly reduced pro‑inflammatory myeloid IL‑6 and TNF transcript expression and increased ARG1, while enhancing Treg‑associated IL‑2Ra (CD25), TGF‑b1 and CTLA‑4 transcripts. In cortical and hippocampal tissues, it significantly lowered IL‑6 and IL‑1b and increased CD163 and CD206, markers of anti‑inflammatory M2 macrophages, whereas monotherapies produced limited changes. Treatment began 24 hours after LPS administration, indicating effects after inflammatory induction had started. Coya believes these results support further evaluation of COYA 303 in Alzheimer’s disease and other complex neurodegenerative indications and plans to pursue non‑dilutive funding and potential partnerships.
Coya Therapeutics (NASDAQ: COYA) reported Q2 2026 results and a pipeline update focused on lead biologic COYA 302 for ALS and frontotemporal dementia (FTD). Enrollment in the Phase 2 ALSTARS ALS trial is proceeding as planned, with completion targeted in 2H 2026 and topline data expected in Q1 2027. The company plans to initiate a Phase 2 FTD study of COYA 302 in 2H 2026 and reported that the first ALSTARS cohort has entered the 24‑week blinded extension phase. COYA 302 also received FDA Fast Track Designation for ALS.
Coya ended June 30, 2026 with $43.2 million in cash and cash equivalents, which the company expects will fund operations past the ALSTARS topline readout and into 2H 2027. Q2 2026 collaboration revenue was $0.24 million. Research and development expenses rose to $5.0 million, while general and administrative expenses declined to $2.3 million. Net loss for the quarter was $6.6 million, or $0.28 per basic and diluted share, compared with a net loss of $6.1 million, or $0.36 per share, in Q2 2025.
Coya Therapeutics (NASDAQ: COYA) will present the ALSTARS Phase 2 trial design for Coya 302 at the ENCALS 2026 Meeting in Madrid, Spain, June 24–26, 2026.
The poster highlights a precision immunomodulatory approach targeting regulatory T cells and neuroinflammation in ALS, presented on June 24, 2026.
Coya Therapeutics (NASDAQ: COYA), a clinical-stage biotechnology company focused on Treg-targeted biologics for neurodegenerative disorders, will host a virtual webinar on June 24, 2026 at 4 p.m. ET / 1 p.m. PT.
The event, titled “Beyond the Hit: How Repetitive Head Trauma, Inflammation, and Neurodegenerative Disease Intersect”, will examine links between repetitive head trauma, chronic inflammation, and conditions such as CTE and ALS. NFL broadcaster and former Cincinnati Bengals player Solomon Wilcots will moderate. Speakers include ALS researcher Stanley H. Appel, M.D., Coya president and chief medical officer Fred Grossman, D.O., and sports agent and concussion-awareness advocate Leigh Steinberg. The live webinar will feature written Q&A, requires pre-registration, and a recording will be posted on Coya’s website.
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.