| Grab Sources Here: SER Website. SER Presentation. -----
(NYSE: SER) - These 5 Potential Catalysts Have Gained Our Attention!
#1. SER Potential Catalyst - A Low Float Could Create An Environment For Heightened Volatility.
According to info from the Yahoo Finance website, SER has a fairly low float.
The website reports this profile to have roughly 3.08Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility potential. -----
#2. SER Potential Catalyst - FDA Endorsement Accelerates Serina’s SER-252 Parkinson’s Treatment Pathway Progress.
Serina Therapeutics Announces FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson’s Disease under 505(b)(2) NDA Pathway
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), ..., 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. “Based on the FDA’s written feedback, we plan to advance SER-252 on a registration-directed 505(b)(2) NDA regulatory pathway. Our development plan is designed to be rigorous and capital efficient. We aim to streamline a potential NDA while generating the clinical and pharmacologic evidence to support regulatory review and improve patients’ lives.”
In its discussions with the FDA, Serina outlined a program designed to leverage prior knowledge of apomorphine utilizing the company’s POZ-enabled profile. Serina plans to include a pharmacokinetic (PK) bridging component to an approved apomorphine product, consistent with a 505(b)(2) NDA strategy. The FDA’s feedback indicates that Serina’s initial study may be designed and conducted as a component of a registrational trial program, subject to standard clinical and nonclinical requirements and finalization of documentation at the time of IND submission.
“Beyond SER-252, we are advancing a pipeline of POZ-enabled small molecules that may follow similar 505(b)(2) NDA pathways where appropriate,” said Mr. Ledger. “The FDA’s 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 regulatory pathway. Each program will follow its own science and require FDA dialogue, but our goal remains to unlock new possibilities in treatment and deliver better options to patients as quickly as possible.”
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Read the full article here. -----
#3. SER Potential Catalyst - Serina Progresses Weekly Injectable Innovation For Tardive Dyskinesia Patients.
Serina Therapeutics Advances POZ-VMAT2i into Development for Tardive Dyskinesia (TD)
- 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), ..., 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. The candidate is designed to meet the needs of underserved TD patients who struggle with daily medication adherence, including those already managed with long-acting injectable (LAI) antipsychotics.
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“POZ-VMAT2i embodies Serina’s commitment to solving real-world challenges for patients and caregivers who are often left behind by traditional therapies,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “By targeting non-compliant, institutionalized, and dysphagic patients with a transformative once-weekly injectable, we believe we can meaningfully expand access to proven VMAT2 inhibitor therapy and improve patient lives.”
Read the full article here. -----
#4. SER Potential Catalyst - Strategic Financing Empowers Serina’s Progress Toward Parkinson’s Breakthrough Therapy Approval.
Serina Therapeutics Secures Up to $20Mn to Advance Registrational Trial of SER-252 in Parkinson’s Disease
Transaction structured to provide flexible funding to support Phase 1b registrational clinical study program in advanced Parkinson’s under the 505(b)(2) NDA pathway
Evaluating complementary funding including strategic equity and non-dilutive alternatives
HUNTSVILLE, AL, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), ..., today announced that it has entered into an agreement to access up to $20Mn 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 $20Mn.
“This financing provides the resources to advance SER-252 through critical clinical milestones on the path toward registration," said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “Importantly, the structure allows us to deploy capital in step with trial progress, while maintaining flexibility to access additional non-dilutive and strategic funding. We believe SER-252 has the potential to transform treatment for those with advanced Parkinson’s disease.”
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Read the full article here. -----
#5. SER Potential Catalyst - Two Analyst Targets Imply That SER May Be Significantly Undervalued From Current Chart Levels.
TipRanks is sharing at least two analyst targets for SER: |