Serina Therapeutics Provides Regulatory Update on SER-252 Program
Serina Therapeutics (NYSE: SER) announced on November 3, 2025 that the FDA has placed a clinical hold on the IND for SER-252, its lead program for advanced Parkinson’s disease, while requesting additional information about a commonly used formulation excipient.
Serina said the FDA feedback does not relate to the active drug substance or mechanism of action, expects the formal clinical‑hold letter within 30 days, and will work expeditiously with the FDA to resolve the request. The company reiterated prior FDA support for a 505(b)(2) NDA pathway and noted ongoing advancement of its broader POZ Platform pipeline.
Serina Therapeutics (NYSE: SER) ha annunciato il 3 novembre 2025 che la FDA ha imposto un blocco clinico sull'IND per SER-252, il suo programma principale per la malattia di Parkinson avanzata, richiedendo nel contempo ulteriori informazioni su un eccipiente di formulazione comunemente usato.
Serina ha affermato che il feedback della FDA non riguarda la sostanza attiva o il meccanismo d'azione, si aspetta la lettera formale di blocco clinico entro 30 giorni e collaborerà in modo rapido con la FDA per risolvere la richiesta. L'azienda ha ribadito il precedente supporto FDA per un percorso NDA 505(b)(2) e ha osservato il continuo avanzamento del suo ampio portafoglio POZ Platform.
Serina Therapeutics (NYSE: SER) anunció el 3 de noviembre de 2025 que la FDA ha puesto una suspensión clínica en el IND de SER-252, su programa principal para la enfermedad de Parkinson avanzada, mientras solicita información adicional sobre un excipient de formulación comúnmente usado.
Serina indicó que los comentarios de la FDA no se relacionan con la sustancia activa o el mecanismo de acción, espera la carta formal de suspensión clínica dentro de 30 días, y trabajará con celeridad con la FDA para resolver la solicitud. La empresa reiteró el apoyo previo de la FDA para una vía NDA 505(b)(2) y señaló el avance continuo de su amplia cartera de la POZ Platform.
Serina Therapeutics (NYSE: SER)은 2025년 11월 3일 FDA가 고급 파킨슨병에 대한 자사의 선도 프로그램인 SER-252의 IND에 임상중단을 부과했고, 일반적으로 사용되는 제형 보조제에 관한 추가 정보를 요청했다고 발표했다.
Serina는 FDA의 피드백이 활성 의약물 성분이나 작용 기전과는 관련이 없다고 말하며, 30일 이내에 공식 임상 중단 서한을 받기를 예상하고, FDA와 신속하게 협력해 요청을 해결하겠다. 회사는 505(b)(2) NDA 경로에 대한 FDA의 사전 지지를 재차 언급했고, 광범위한 POZ 플랫폼 파이프라인의 지속적 진전을 지적했다.
Serina Therapeutics (NYSE: SER) a annoncé le 3 novembre 2025 que la FDA a mis en place une suspension clinique sur l'IND de SER-252, son programme phare pour la maladie de Parkinson avancée, tout en demandant des informations complémentaires sur un excipient de formulation couramment utilisé.
Serina a déclaré que les retours de la FDA ne concernent pas la substance active ou le mécanisme d'action, s'attend à recevoir la lettre formelle de suspension clinique dans 30 jours, et travaillera avec la FDA de manière expéditive pour résoudre la demande. L'entreprise a réitéré son soutien antérieur de la FDA pour une voie NDA 505(b)(2) et a noté l'avancement continu de son vaste pipeline POZ Platform.
Serina Therapeutics (NYSE: SER) gab am 3. November 2025 bekannt, dass die FDA eine klinische Suspendierung des IND für SER-252, ihr führendes Programm zur fortgeschrittenen Parkinson-Krankheit, angeordnet hat, während sie zusätzliche Informationen zu einem häufig verwendeten Formulierungs-Excipienten anfordert.
Serina sagte, dass das FDA-Feedback nichts mit der aktiven Arzneistoffsubstanz oder dem Wirkmechanismus zu tun hat, erwartet das formale Schreiben über die klinische Suspendierung innerhalb von 30 Tagen und wird eng mit der FDA zusammenarbeiten, um die Anfrage zu klären. Das Unternehmen bekräftigte zuvor die FDA-Unterstützung für einen 505(b)(2) NDA-Pfad und wies auf die fortgesetzte Weiterentwicklung seiner breiteren POZ Platform-Pipeline hin.
Serina Therapeutics (NYSE: SER) أعلنت في 3 نوفمبر 2025 أن إدارة الغذاء والدواء الأمريكية (FDA) وضعت تعليقاً سريرياً على IND الخاص بـ SER-252، برنامجه الرائد لمرض باركنسون المتقدم، مع مطالبة بمعلومات إضافية حول مركب مساعد للصيغة مستخدم عادةً.
وقالت Serina إن ملاحظات FDA لا تتعلق بالمواد الفعالة أو آلية العمل، وتتوقع رسالة تعليق سريري رسمية خلال 30 يوماً، وستعمل بسرعة مع FDA لحل الطلب. وأكدت الشركة دعم FDA السابق لمسار NDA من نوع 505(b)(2) وذكرت التقدم المستمر لمحفظة POZ Platform الأوسع.
- FDA feedback excludes the active drug substance or mechanism
- Company expects formal clinical-hold letter within 30 days
- Prior FDA interactions indicated support for a 505(b)(2) pathway
- FDA placed a clinical hold on the SER-252 IND
- Regulatory request targets a formulation excipient, delaying IND progress
- Initiation of registrational SER-252 trial will be postponed pending resolution
Insights
FDA placed a clinical hold on the SER-252 IND due to questions about a formulation excipient; Serina will supply additional data within regulatory timelines.
The clinical hold stops initiation of the planned registrational Phase 1b study until the FDA receives and accepts additional information about a commonly used excipient; the hold does not concern the active drug substance or the proposed mechanism of action. This distinction limits the scope of the issue to CMC/formulation documentation or safety data for the excipient rather than efficacy or target biology, which keeps the underlying therapeutic hypothesis intact.
Key dependencies include how quickly the company can provide the requested data and whether the FDA requires new studies or simply additional documentation; Serina expects the formal clinical‑hold letter within
- FDA requests additional information on a formulation component -
HUNTSVILLE, AL, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Company’s Investigational New Drug (IND) application for SER-252, Serina’s lead development program for advanced Parkinson’s disease. The FDA has requested additional information related to a commonly used excipient in the formulation. The feedback does not relate to the active drug substance or its proposed mechanism of action. Serina intends to work expeditiously with the FDA to address the requests.
Serina expects to receive the FDA’s formal clinical-hold letter within 30 days and will provide an update once it has aligned with the FDA on next steps and timelines. In prior interactions, the FDA indicated support for Serina’s development approach for SER-252 under a 505(b)(2) NDA pathway.
“We appreciate the FDA’s engagement and constructive feedback. We will provide the additional information requested promptly as we continue to move forward in the registrational trial for SER-252,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “Importantly, the feedback does not relate to the underlying drug candidate or its intended mechanism, and we continue to believe strongly in the potential of SER-252 to improve treatment options for people living with advanced Parkinson’s disease.”
“I remain fully committed to supporting Serina, both financially and strategically, to help ensure progress toward initiating the SER-252 clinical program. Regulatory feedback of this kind is a normal and constructive part of responsible drug development. The team has our full confidence as they work closely with the FDA to address its comments. This update does not change our conviction in Serina’s long-term potential or our belief in SER-252’s ability to meaningfully improve the lives of patients with advanced Parkinson’s disease,” said Greg Bailey, MD, Board Member of Serina and Co-Founder and Executive Chairman of Juvenescence.
Serina continues to advance its broader POZ Platform®-based small molecule pipeline, including SER-270 (POZ-VMAT2i), a once-weekly injectable therapy for tardive dyskinesia (TD), and our POZ-LNP, POZ-ADC, and POZ-AOC platform science.
SER-252 Registrational Study Design Overview
The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose (five cohorts of eight; n=40) and multiple-ascending-dose components (up to three cohorts of sixteen; n=48) in adults with Parkinson’s disease and motor fluctuations. The study is designed to evaluate safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures that include MDS-UPDRS motor scores and structured motor-state assessments. Dose escalation will be overseen by a Safety Review Committee and the study will be conducted across sites in the U.S. and Australia.
About SER-252 (POZ-apomorphine)
SER 252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS) via a single or twice-weekly subcutaneous injection. CDS has been shown to reduce the severity of motor fluctuations (which includes levodopa-induced dyskinesia) and enable greater daily on time, with reduced off time, in advanced Parkinson’s patients. SER-252 leverages strategic partner Enable Injections’ enFuse™ wearable drug delivery platform to enhance patient comfort and convenience, providing CDS to patients via an easy-to-administer, long-acting subcutaneous injection.
About the POZ Platform™
Serina’s proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina’s POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. The therapeutic agents in Serina’s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include severe skin reactions, side effects due to peak-trough variations in drug levels and a short half-life. Serina believes that by using POZ technology, drugs with a narrow therapeutic index can be designed to maintain more desirable and stable levels in the blood. Serina’s POZ platform delivery technology has potential for use across a broad range of payloads and indications.
About Serina Therapeutics
Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina’s POZ Platform™ provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology. For more information, please visit https://serinatx.com .
Cautionary Statement Regarding Forward-Looking Statement
This release contains forward-looking statements within the meaning of federal securities laws. These statements are based on management’s current expectations, plans, beliefs, or forecasts for the future, and are subject to uncertainty and changes in circumstances. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina’s POZ polymer technology, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the timing and extent of the FDA's clinical-hold letter and of Serina's response; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; and competitive developments. These risks as well as other risks are more fully discussed in Serina’s Annual Report on Form 10-K, and Serina’s other periodic reports and documents filed from time to time with the SEC. The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
For inquiries, please contact:
Stefan Riley
sriley@serinatherapeutics.com
(256) 327-9630
FAQ
What did Serina Therapeutics (SER) announce on November 3, 2025 about SER-252?
Does the FDA hold for SER-252 relate to the active drug or mechanism for SER (NYSE: SER)?
When does Serina expect the FDA's formal clinical‑hold letter for SER-252 (SER)?
Will the SER-252 registrational trial start as planned after the November 3, 2025 update?
What regulatory pathway did the FDA previously indicate support for regarding SER-252 (SER)?
