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Monday, July 15, 2024 10:00:47 AM
On June 14, 2024, Coya Therapeutics, Inc. (the “Company”) submitted to the U.S. Food and Drug Administration (the “FDA”) an Investigational New Drug Application (the “IND”) seeking to initiate a study entitled “Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study with Additional 24-Week Open Label Extension (OLE) to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)” (the “Study”). On July 12, 2024, the Company received an email notification from the FDA stating that additional non-clinical data is required prior to the initiation of the Study. The FDA also stated that it would provide the Company with more details about what additional information it requires within the next thirty (30) days.
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Recent COYA News
- Coya Therapeutics to Participate in Fireside Chat at the Chardan 8th Annual Genetic Medicines Conference • Business Wire • 09/24/2024 12:15:00 PM
- Coya Therapeutics Announces Subcutaneously Administered COYA 302 Elicits Direct Anti-Inflammatory Effect in Brain in a Preclinical Inflammatory Mouse Model of Parkinson’s Disease • Business Wire • 09/16/2024 12:15:00 PM
- Coya Therapeutics to Present at Upcoming Healthcare Conferences • Business Wire • 09/03/2024 12:15:00 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 07:56:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/19/2024 01:10:00 PM
- Coya Therapeutics Promotes Arun Swaminathan Ph.D. to Chief Executive Officer Effective November 1st, 2024 • Business Wire • 08/19/2024 01:00:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/12/2024 12:13:47 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/12/2024 12:04:26 PM
- Coya Therapeutics Provides a Corporate Update and Reports Unaudited Second Quarter 2024 Financial Results • Business Wire • 08/12/2024 12:00:00 PM
- Coya Therapeutics Announces that Results from a Double-Blind Placebo-Controlled Study in Alzheimer’s Disease will be presented on October 29, 2024 at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid • Business Wire • 08/02/2024 12:15:00 PM
- Coya Therapeutics Expands Pipeline and Intellectual Property Portfolio with Filing of New U.S. Patents for COYA 301 in Combination with Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists • Business Wire • 07/31/2024 12:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/15/2024 10:10:01 AM
- Coya Therapeutics Expands Sponsored Research Collaboration with Houston Methodist Research Institute Along with Funding from the Johnson Center for Cellular Therapeutics to Advance Regulatory T Cell Exosome Platform into the Clinic • Business Wire • 06/20/2024 12:15:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 06/14/2024 09:01:07 PM
- Coya Therapeutics Announces Publication of ALS Study in Peer-Reviewed Journal Frontiers in Neurology • Business Wire • 06/11/2024 12:15:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/06/2024 12:00:04 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/06/2024 12:00:03 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 12:00:32 PM
- Coya Therapeutics Announces Acceptance of Peer-Reviewed Manuscript in the Medical Journal: Frontiers in Neurology • Business Wire • 06/03/2024 12:15:00 PM
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- Coya Therapeutics Announces the Completion of a Controlled Phase 2 Study of Low Dose Interleukin-2 (LD IL-2) in Patients with Alzheimer’s Disease • Business Wire • 05/22/2024 12:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/20/2024 09:00:35 PM
- Coya Therapeutics Announces $5 Million Strategic Investment by the Alzheimer’s Drug Discovery Foundation (ADDF) • Business Wire • 05/20/2024 12:15:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:26:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 08:20:17 PM
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