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Current Report · Items 8.01, 9.01 · 8-K
SERNYSE_AMERICANEQUITYCurrent
Item 8.01 Other Items On January 28, 2026, the Company issued a press release announcing that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SER-252, an investigational therapy for advanced Parkinson’s disease.…
We are a clinical-stage biotechnology company developing a pipeline of wholly-owned drug product candidates to treat neurological diseases and other indications. Our POZ Platform™ (“POZ”) drug delivery technology is designed to enable certain existing drugs and novel drug candidates to be modified in a way that may provide an improved efficacy and safety profile of the resulting polymeric drug conjugate. Our business is largely focused on the development of a wholly-owned pipeline of POZ-enabled drug candidates for central nervous system (“CNS”) indications, including Parkinson’s disease. Our lead product candidate, SER-252 (POZ-apomorphine), is a POZ conjugate of the dopamine agonist apomorphine being developed for the treatment of advanced Parkinson’s disease. In January 2026, we received clearance of our Investigational New Drug application from the U.S. Food and Drug Administration for SER-252. In February 2026, we enrolled and dosed our first patient in our Phase 1b single-ascending dose (“SAD”) clinical trial for SER-252. For additional information about our business, operations, and financial results, see the documents listed under “Where You Can Find More Information.”
Serina Therapeutics, Inc. · 8-K · Filed 2026-01-28