08:36 AM EDT, 08/25/2025 (MT Newswires) -- Coya Therapeutics ( COYA ) said Monday that the US Food and Drug Administration has accepted its investigational new drug application for COYA 302, an experimental immunotherapy to potentially treat amyotrophic lateral sclerosis, or ALS.

The company said it is preparing to launch a phase 2 trial to assess the drug's safety and effectiveness.

The FDA's acceptance of the application also triggers a $4.2 million milestone payment to the company from its partner, DRL, it added.

Shares of the company were up more than 8% in recent premarket activity Monday.