Investing.com -- Serina Therapeutics Inc (NYSE:SER) stock surged 30.2% in after-hours trading Wednesday following FDA clearance of its Investigational New Drug application for SER-252, a treatment for advanced Parkinson’s disease.
The regulatory green light allows Serina to proceed with site-level activities to initiate its planned Phase 1b registrational clinical study. The company has already begun clinical site start-up and regulatory activities in Australia to support its global registrational program.
"FDA clearance of the IND is a major milestone for Serina and underscores the promise of the SER-252 program," said Steve Ledger, Chief Executive Officer of Serina Therapeutics. "As we initiate our registrational study, we will begin generating meaningful clinical data for SER-252 in patients with advanced Parkinson’s disease."
The company noted that it has engaged in multiple regulatory interactions with the FDA regarding the SER-252 program. These discussions resulted in FDA feedback supporting the proposed registrational clinical trial design under a 505(b)(2) NDA pathway, which could provide a more efficient route to potential approval.
Serina Therapeutics is a clinical-stage biotechnology company developing treatments using its proprietary POZ Platform technology. The company claims this platform has the potential to improve efficacy and safety profiles across multiple therapeutic modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates.
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