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Serina Therapeutics shares jumped nearly 35% after the FDA cleared its IND application for SER-252, advancing plans for a Phase 1b trial in advanced Parkinson's disease.
- Phase 1b clinical site start-up and regulatory activities in Australia underway to support the global registrational program -
HUNTSVILLE, Jan. 15, 2026 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ PlatformTM drug optimization technology, received a notice from the New York Stock Exchange ("NYSE") that it is below the continued listing criteria under Sections 1003(a)(i) and (ii) of the NYSE's listing standards set forth in Part 10 of the NYSE American Company Guide ("Company Guide"), because the Company reported stockholders' equity of $1.6 million as of September 30, 2025, and has had losses in three of its four most recent fiscal years ended December 31, 2024. The Company is also not currently eligible for any exemption in Section 1003(a) of the Company Guide from the stockholders' equity requirements.
HUNTSVILLE, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ PlatformTM drug optimization technology, today announced the appointment of Joshua Thomas, Ph.D., as Vice President and Head of Chemistry. He will oversee internal and external chemistry efforts to optimize POZ-based candidates, supporting efficient translation from discovery through development.
– Company addresses FDA requests regarding formulation excipient – Global site start-up activities continue, with first-patient-in for registrational Phase 1b study targeted for Q1 2026, subject to FDA feedback
HUNTSVILLE, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ Platform™ drug optimization technology, today announced its financial results for the third quarter ended September 30, 2025, along with key recent updates.
- 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.
Liquid formulation has potential to expand patient access, including those in intensive care, to SER-155 for the prevention of bloodstream and antimicrobial resistant (AMR) infections Liquid formulation has potential to expand patient access, including those in intensive care, to SER-155 for the prevention of bloodstream and antimicrobial resistant (AMR) infections
HUNTSVILLE, AL., Oct. 08, 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 the launch of a comprehensive corporate communications platform designed to deliver timely, transparent updates to patients, clinicians, investors, and the broader scientific community.
HUNTSVILLE, AL, Oct. 06, 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 the drawdown of the first $5 million tranche from its previously announced financing agreement, which provides up to $20 million in funding upon achievement of defined development milestones. Proceeds will be used to advance the Company's planned registrational trial of SER-252 for the treatment of advanced Parkinson's disease.
Following recent constructive FDA feedback, Seres anticipates finalizing SER-155 Phase 2 study protocol for the prevention of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant for the treatment of hematological malignancies
HUNTSVILLE, AL, Sept. 09, 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 it has entered into an agreement to access up to $20 million in financing led by Serina Board Director Greg Bailey, MD. The financing also includes the issuance of warrants which, if fully issued and exercised, could result in additional proceeds of up to $20 million.
- U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026 - Patient dosing expected to begin in Australia in Q4 2025 HUNTSVILLE, AL, Aug. 25, 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 following a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA's written feedback supports advancing SER-252 (POZ-apomorphine) in a registrational clinical study program in advanced Parkinson's under the 505(b)(2) NDA pathway. “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,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics.
HUNTSVILLE, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company advancing its lead IND candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ Platform™ drug optimization technology, today announced its financial results for the second quarter ended June 30, 2025, along with key recent updates.
Following FDA input, Seres submitted Phase 2 study protocol to FDA for SER-155 for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) to treat hematological malignancies Seres engaging with multiple parties regarding various deal structures, including potential business development and partnerships, intended to secure capital and other resources to enable the clinical advancement of SER-155 and additional live biotherapeutic product candidates Seres received the $25 million installment payment, as expected, from Nestlé Health Science in July 2025 Conference call at 8:30 a.m. ET today CAMBRIDGE, Mass.
BONN, Germany--(BUSINESS WIRE)--SER, the leading provider of Intelligent Content Automation solutions, today announces the launch of two powerful solution bundles: Doxis Purchase-to-Pay for SAP and Doxis Order-to-Cash for SAP. Manual workflows or ineffective legacy automation, now combined with exploding global data volumes — expected to reach 390 zettabytes of documents created per year by 2028 — are currently slowing down purchase-to-pay (P2P) and order-to-cash (O2C) processes, making it hard.
Seres Therapeutics's VOWST divestiture injected cash, retired debt, and refocused the company as a clinical‑stage microbiome specialist. Their current lead candidate is SER‑155, which seems to reduce bloodstream infections up to 77% according to their Phase 1b trial. SER-155 also holds the FDA's Breakthrough and Fast Track designations. MCRB targets more interim Phase 2 SER‑155 data within 12 months.
- Novel once-weekly injectable VMAT2 inhibitor targets underserved patients with serious adherence and access challenges – - Potential expansion into Huntington's chorea – an underserved indication with high need for long-acting VMAT2 therapy - HUNTSVILLE, AL, July 29, 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 the advancement of its novel product candidate, SER-270, a proprietary POZ-conjugated vesicular monoamine transporter 2 (VMAT2) inhibitor in development for the treatment of tardive dyskinesia (TD). SER-270, also referred to as POZ-VMAT2i, leverages Serina's proprietary POZ polymer technology to enable long-acting, once weekly subcutaneous administration, offering a potentially transformative alternative to existing oral VMAT2 inhibitors.
HUNTSVILLE, AL, July 28, 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 Steve Ledger, Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference, taking place July 29-30, 2025. The discussion will be held on Tuesday, July 29, 2025, at 2:00 p.m. ET.