The FDA backed advancing its Parkinson’s drug candidate SER-252 into a registrational clinical program, a move that retail traders said could fuel further gains.
Shares of Serina Therapeutics surged 37% in after-hours trading on Monday after the company said the U.S. Food and Drug Administration (FDA) supported advancing its Parkinson’s drug candidate SER-252 (POZ-apomorphine) into a registrational clinical program.
The stock ended Monday’s session down 0.2% at $5.64, but surged 37.2% to $7.74 in after-hours trading following the FDA update.
The FDA feedback followed a recent Type B meeting and paves the way for Serina to move forward with a streamlined regulatory strategy.
“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,” CEO Steve Ledger said, adding that the company’s plan is designed to be both rigorous and capital efficient.
The proposed program will leverage prior knowledge of apomorphine while incorporating Serina’s POZ-enabled profile. According to the FDA’s feedback, Serina’s first study could be designed as part of its overall registrational trial program, subject to final documentation at the time of IND submission.
Serina plans to submit a U.S. IND application in the fourth quarter of 2025 and begin dosing patients in Australia later this year, with the data expected to feed into the global registrational package. U.S. patient enrollment is anticipated to begin in the first quarter of 2026, once the IND is cleared.
The planned SER-252-1b study will test the therapy in up to 88 adults with Parkinson’s disease and motor fluctuations, evaluating safety, tolerability, pharmacokinetics, and exploratory efficacy measures, including MDS-UPDRS motor scores.
SER-252 is designed to provide continuous dopaminergic stimulation (CDS) via once- or twice-weekly subcutaneous injections, utilizing Enable Injections’ enFuse wearable delivery platform to enhance patient comfort and convenience.
Serina believes its POZ drug optimization technology can help stabilize drug levels and reduce side effects compared with traditional therapies.
Ledger said the FDA’s response also validated Serina’s broader pipeline ambitions: “The feedback provides early proof-of-principle for our platform, confirming that we can effectively align with the agency’s expectations for the 505(b)(2) NDA pathway.”
On Stocktwits, retail sentiment was ‘extremely bullish’ amid ‘extremely high’ message volume.
One user suggested that Serina shares could continue to rise in the next session and said they were already “fully loaded.”
Another user speculated whether Serina’s stock could reach $20 as soon as the next trading session.
Serina’s stock has risen 12.6% so far in 2025.
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