Shares of Serina Therapeutics (NYSE: SER) climbed sharply in after-hours trading, rising 30.2% following regulatory news that the U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for SER-252, a therapeutic candidate aimed at treating advanced Parkinson's disease.
The IND clearance authorizes the company to move forward with site-level activities necessary to launch a planned Phase 1b registrational clinical study. Serina indicated it has already initiated clinical site start-up and undertaken regulatory work in Australia to support a coordinated global registrational effort.
"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."
Company statements note that Serina engaged in multiple regulatory exchanges with the FDA about the SER-252 program. Those discussions produced FDA feedback that supports the trial design proposed for a registrational study under a 505(b)(2) new drug application pathway - a route the company says could provide a more efficient path toward potential approval.
Serina Therapeutics describes itself as a clinical-stage biotechnology company developing therapeutics using its proprietary POZ Platform technology. The firm asserts the platform may enhance efficacy and safety profiles across diverse therapeutic modalities, including small molecules, RNA-based therapies, and antibody-drug conjugates.
The IND clearance and the start of site-level actions mark a procedural advance in Serina's development timeline, enabling the operational work needed to enroll patients and collect clinical data in the upcoming registrational study. The company has made regulatory and clinical site preparations in Australia to support its global program, while continuing interactions with the FDA regarding study design and regulatory strategy.
What this means
- The FDA's IND clearance allows Serina to commence site-level activities for a Phase 1b registrational study of SER-252 in advanced Parkinson's patients.
- Regulatory engagement with the FDA produced feedback consistent with pursuing a 505(b)(2) NDA pathway, which the company notes could be more efficient for potential approval.
- Serina has begun site start-up and regulatory activities in Australia as part of a global registrational program.
Investors and market participants will be watching for the initiation of the registrational study and the clinical data that the company expects to generate during the trial. The pace of site activation, enrollment and subsequent data readouts will shape the program's next milestones.