Coya Therapeutics CEO Arun Swaminathan Discusses FDA Clearance, Partnerships, and 2025 Milestones for ALS and Neurodegeneration Programs

Coya Therapeutics, a clinical-stage biotech company, has received FDA clearance for its IND application for COYA 302 in amyotrophic lateral sclerosis (ALS). The company is also expanding its pipeline beyond ALS with an IND filing for frontotemporal dementia expected in late 2025. Strategic partnerships, including with Dr. Reddy's Laboratories, provide financial support and expertise. Key milestones for 2025 include ALS trial initiation, FTD data readouts, and new preclinical results across multiple programs.

Coya Therapeutics, a clinical-stage biotechnology company, has made significant strides in its mission to address neurodegenerative diseases. On September 3, 2025, the company received FDA clearance for its Investigational New Drug (IND) application for COYA 302 in amyotrophic lateral sclerosis (ALS). This clearance enables the initiation of a pivotal Phase 2 clinical trial, marking a crucial milestone in the development of potential therapies for ALS [1].

In addition to its progress in ALS, Coya Therapeutics is expanding its pipeline beyond this condition. The company plans to file an IND for frontotemporal dementia (FTD) in late 2025. This expansion highlights Coya’s commitment to tackling various neurodegenerative diseases. The company is also making progress on its COYA 303 program, which combines low-dose IL-2 with GLP-1 agonists [1].

Strategic partnerships have been instrumental in Coya’s advancements. The company has formed a partnership with Dr. Reddy’s Laboratories, which provides financial support and expertise in manufacturing, regulatory pathways, and commercialization. This collaboration underscores Coya’s commitment to leveraging external expertise to accelerate its therapeutic development [1].

Key milestones for 2025 include the initiation of the ALS trial, data readouts for FTD, and new preclinical results across multiple programs. These milestones are expected to further propel Coya Therapeutics’ efforts in making neurodegenerative diseases more livable [1].

References:
[1] https://www.nasdaq.com/press-release/prism-marketview-features-exclusive-qa-coya-therapeutics-ceo-arun-swaminathan