Serina Therapeutics Shares Surge 25% Amid FDA Feedback

Serina Therapeutics shares rose 25.3% pre-market after the FDA provided written feedback supporting the advancement of SER-252. Invivyd shares gained 84.1% after the company received a positive written opinion from the International Searching Authority for a patent covering the HD144 printing system. ESSA Pharma shares dipped 59.8% after announcing an $80 million capital distribution was paid.

Serina Therapeutics, Inc. (NYSE American: SER) saw its shares rise by 25.3% in pre-market trading after the U.S. Food and Drug Administration (FDA) provided written feedback supporting the advancement of SER-252, a POZ-enabled apomorphine treatment for advanced Parkinson's disease, through a 505(b)(2) New Drug Application (NDA) pathway [1].

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. This regulatory milestone significantly de-risks Serina's strategy while maintaining a long development timeline [1].

Serina plans to submit the U.S. Investigational New Drug (IND) application in Q4 2025, incorporating the FDA’s recommendations. The company also 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 [1].

The registrational study, SER-252-1b, is designed as a randomized, double-blind, placebo-controlled Phase 1b trial, evaluating safety, tolerability, and pharmacokinetics in Parkinson's disease patients with motor fluctuations. The study will be conducted across sites in the U.S. and Australia [1].

Serina's proprietary POZ technology is based on a synthetic, water-soluble, low-viscosity polymer called poly(2-oxazoline). The POZ platform is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection [1].

The FDA's feedback supports Serina's 505(b)(2) pathway for SER-252, allowing the company to leverage existing data on apomorphine while incorporating their proprietary POZ Platform™ technology. This approach can substantially reduce development costs and timeline risks compared to traditional development pathways [1].

Serina Therapeutics is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. The company is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology [1].

References:
[1] https://finance.yahoo.com/news/serina-therapeutics-announces-fda-feedback-201500193.html