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Coya Therapeutics to Launch Extension for ALS Trial and Delay Dementia Study

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Coya Therapeutics, Inc. (COYA) announced plans to launch an open-label extension for its Phase 2/3 ALSTARS trial testing COYA 302 in patients with amyotrophic lateral sclerosis (ALS). The extension is scheduled to begin in November 2026 as the initial trial cohort completes the 48-week treatment period, allowing participants to continue receiving the therapy while researchers collect additional safety and efficacy data.

To support the ALS program and secure important near-term milestones, Coya Therapeutics, Inc. (COYA) is reprioritizing its resources. As a result, the company is postponing the planned Phase 2 clinical trial of COYA 302 in frontotemporal dementia from the second half of 2026 into 2027. Despite the timeline shift, management reconfirmed that its cash runway remains sufficient to fund company operations into the second half of 2027.

Shares of Coya Therapeutics, Inc. (COYA) traded down 6.96% to $4.475 following the announcement. Investors will monitor the rollout of the trial extension in late 2026, alongside upcoming topline data from the main ALSTARS study expected prior to the end of the company's cash runway.

Key points

  • Coya Therapeutics, Inc. (COYA) will launch an open-label extension of its Phase 2/3 ALSTARS trial in ALS starting November 2026.
  • The company postponed its Phase 2 trial of COYA 302 in frontotemporal dementia from late 2026 to 2027 to focus resources on ALS.
  • Coya Therapeutics, Inc. (COYA) reaffirmed that existing cash resources will fund operations into the second half of 2027.
  • Shares of Coya Therapeutics, Inc. (COYA) dropped 6.96% to $4.475 following the operational update.

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Questions and answers

What is Coya Therapeutics doing with its ALS clinical trial?

Coya Therapeutics is launching an open-label extension of its Phase 2/3 ALSTARS trial in November 2026, allowing patients who finish 48 weeks of treatment to continue receiving COYA 302.

Why was the frontotemporal dementia trial delayed?

The company delayed the Phase 2 trial in frontotemporal dementia to 2027 so it could prioritize financial and operational resources toward the ALS clinical study.

How long is Coya Therapeutics funded?

The company expects its current cash resources to fund operations into the second half of 2027, past the anticipated readout of topline data from the ALSTARS trial.