What milestones were achieved for the lead IND candidate SER-252, and what is the timeline for IND filing or FDA interactions?
Milestones for SERâ252
Serina announced that its lead IND candidate, SERâ252, has reached the âINDâreadyâ stage. The company completed all preâclinical work required for a U.S. filingâincluding GLPâcompliant toxicology, pharmacokinetic and doseârangeâfinding studies, and a full INDâenabling data package generated on its proprietary POZ Platformâą. The data package was cleared by the internal regulatory team and is now being compiled for submission, positioning SERâ252 as the first POZâplatformâderived therapy to target advanced Parkinsonâs disease.
Timeline for IND filing & FDA interaction
Serina expects to submit the IND for SERâ252 in lateâŻ2025 (Q4). Following the filing, the company has scheduled a TypeâŻB meeting with the FDA in earlyâŻ2026 (approximately Q1) to discuss the PhaseâŻ1/2a firstâinâhuman study design, dosing strategy, and the anticipated regulatory pathway. The meeting will serve as the primary catalyst for the next 12âmonth price action.
Trading implications
The INDâready status removes a major execution risk and creates a clear, nearâterm catalyst. If the filing proceeds on schedule, the stock could experience a 10â15âŻ% rally on the Q4 filing news, with a secondary boost when the FDA meeting details are disclosed in Q1âŻ2026. Technical charts show the stock holding near its Q2 2025 high (~$12.30) with a modest upward bias; a breakout above this level on filing news would likely trigger shortâterm buying. Conversely, any delay beyond Q4 2025 or a negative FDA meeting tone could expose the shares to downside pressure. Positionally, traders might consider a longâposition with a stop just below the recent low (~$10.80) to capture the upside from the upcoming regulatory milestones while limiting exposure to potential setbacks.