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Investing.com -- Coya Therapeutics Inc (NASDAQ:COYA) stock surged 7.8% in premarket trading Monday after the company announced the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for COYA 302, a treatment for amyotrophic lateral sclerosis (ALS).
The FDA’s acceptance triggers a $4.2 million milestone payment to Coya from Dr. Reddy’s Laboratories Ltd, its partner in developing the proprietary immunomodulatory biologic combination therapy.
Following this regulatory milestone, Coya is preparing to initiate a Phase 2 clinical trial to evaluate the efficacy and safety of COYA 302 in ALS patients. The study will be a multicenter, well-controlled trial, according to the company.
"The FDA’s acceptance of this IND marks a pivotal moment in Coya’s journey. We are now preparing to initiate a well-powered, well-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS," said Arun Swaminathan, Chief Executive Officer of Coya Therapeutics.
Milan Kalawadia, Chief Executive Officer, North America, at Dr. Reddy’s Laboratories commented on the development: "We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study. This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya."
Coya Therapeutics is a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell function in patients with neurodegenerative disorders.
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