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Coya Therapeutics , Inc. (NASDAQ:COYA), a $96 million market cap biotech company, announced Monday that it has resubmitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a planned Phase 2 clinical trial evaluating COYA 302 in the treatment of amyotrophic lateral sclerosis (ALS). The company maintains a strong liquidity position with a current ratio of 8.84, indicating robust short-term financial health.
According to a statement based on a SEC filing, the company’s resubmission includes additional non-clinical data requested by the FDA in July 2024. The planned clinical trial is designed as a randomized, double-blind, placebo-controlled, multi-center, 24-week study, with an additional 24-week open-label extension.
Coya Therapeutics stated that, upon acceptance of the IND by the FDA, it intends to initiate the Phase 2 trial. The company’s common stock is listed on The Nasdaq Stock Market under the ticker COYA.
This information is drawn from a press release statement included in the company’s regulatory filing.
In other recent news, Coya Therapeutics announced the issuance of a U.S. patent for its liquid formulation of interleukin-2 (IL-2), marking a significant step in its intellectual property strategy. The patent, identified as US 12,312,389 B2, covers methods for producing stable liquid formulations of IL-2, which could enhance the delivery and effectiveness of treatments. H.C. Wainwright reaffirmed its Buy rating and $18.00 price target for Coya Therapeutics, citing the potential impact of this patent on the company’s market positioning. Additionally, BTIG maintained its Buy rating with a $15.00 price target, highlighting the upcoming FDA submission for Coya’s Phase 2/3 ALS trial as a critical development. The trial, featuring COYA-302, is anticipated due to promising data from a Phase 1b ALS study. This investigational therapy showed stability in ALS patients and increased T regulatory cell activity. Coya’s CEO, Arun Swaminathan, emphasized the patent’s role in safeguarding the company’s therapeutic assets. The company plans to submit an Investigational New Drug (IND) application for COYA 302 by the end of June, targeting a Phase 2b study in ALS patients.
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