Serina Therapeutics announces FDA support for SER-252 clinical study program

Serina Therapeutics (SER) announced that following a recent Type B meeting with the FDA, the FDA’s written feedback supports advancing SER-252 in a registrational clinical study program in advanced Parkinson’s under the 505 NDA pathway. In its discussions with the FDA, Serina outlined a program designed to leverage prior knowledge of apomorphine utilizing the company’s POZ-enabled profile. Serina plans to include a pharmacokinetic bridging component to an approved apomorphine product, consistent with a 505 NDA strategy. The FDA’s feedback indicates that Serina’s initial study may be designed and conducted as a component of a registrational trial program, subject to standard clinical and nonclinical requirements and finalization of documentation at the time of IND submission. Serina plans to submit the U.S. IND application in Q4 2025 incorporating the FDA’s recommendations. In parallel, the company expects to begin dosing patients in Australia in Q4 2025 as part of the global registrational program, with data from these patients expected to contribute to the overall data package for regulatory review and potential approval. Following U.S. IND clearance, Serina anticipates initiation of enrollment in the U.S. in Q1 2026.