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Serina Therapeutics Announces FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson’s Disease under 505(b)(2) NDA Pathway
- U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026 - Patient dosing expected to begin in Australia in Q4 2025 HUNTSVILLE, AL, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced that following a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA’s written feedback su
About this update from Serina Therapeutics, Inc.
[{"type":"image","alt":"Serina Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Serina Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":84,"url":"https://media.zenfs.com/en/globenewswire.com/f5ef3cecb8662785323a6a370007d6d1"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/vVhesNODR8eRh4qa0Kn9PQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/f5ef3cecb8662785323a6a370007d6d1","width":300,"height":84}},"lazy":false},{"type":"text","content":"- U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026 ","length":92,"tagName":"p"},{"type":"text","content":"- Patient dosing expected to begin in Australia in Q4 2025 ","length":58,"tagName":"p"},{"type":"text","content":"HUNTSVILLE, AL, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced that following a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA’s written feedback supports advancing SER-252 (POZ-apomorphine) in a registrational clinical study program in advanced Parkinson’s under the 505(b)(2) NDA pathway.","length":505,"tagName":"p"},{"type":"text","content":"“People living with advanced Parkinson’s need more consistent relief from motor fluctuations and our data to date suggest that SER-252 may reliably improve daily function,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “Based on the FDA’s written feedback, we plan to advance SER-252 on a registration-directed 505(b)(2) NDA regulatory pathway. Our development plan is designed to be rigorous and capital efficient. We aim to streamline a potential NDA while generating the clinical and pharmacologic evidence to support regulatory review and improve patients’ lives.”","length":589,"tagName":"p"},{"type":"text","content":"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 (PK) bridging component to an approved apomorphine product, consistent with a 505(b)(2) NDA strategy. The FDA’s feedback indicates that Serina’s initial study may b...