PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)
Rhea-AI Summary
PDS Biotech (Nasdaq: PDSB) announced the FDA accepted its request for a Type C meeting, scheduled for December 2025, to discuss a proposed amendment to the Phase 3 VERSATILE-003 trial.
The amendment would make progression-free survival (PFS) a surrogate primary endpoint evaluable earlier with statistical power, potentially enabling an accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer. Median overall survival (mOS) will remain the primary endpoint for full approval. The company cites positive final VERSATILE-002 results showing promising mOS and durable PFS in patients with CPS ≥ 1. FDA meeting minutes are expected in January 2026.
Positive
- FDA accepted Type C meeting request; meeting scheduled December 2025
- VERSATILE-002 reported positive final mOS and durable PFS in CPS ≥ 1
- Proposed amendment could enable accelerated approval via earlier PFS readout
Negative
- mOS retained as primary endpoint for full approval, limiting surrogate scope
- Final FDA position pending; meeting minutes expected January 2026
News Market Reaction – PDSB
On the day this news was published, PDSB gained 6.95%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.5% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $45M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves, with names like CAMP and MAIA up and VTVT down 5.15%, indicating stock-specific rather than broad sector trading around this FDA-meeting update.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 09 | IP / patent win | Positive | +18.0% | New Japanese composition-of-matter patent extending PDS0101 protections into 2040s. |
| Dec 02 | Regulatory interaction | Positive | +7.0% | FDA accepted Type C meeting request on VERSATILE-003 accelerated approval pathway. |
| Nov 13 | Earnings & pipeline | Negative | -12.3% | Q3 loss and liquidity context alongside VERSATILE-002 mOS and PFS data update. |
| Nov 11 | Equity financing | Negative | +8.8% | Dilutive registered direct offering to fund VERSATILE-003 and corporate needs. |
| Nov 10 | Clinical data update | Positive | +7.0% | Positive translational and clinical data for PDS0101 and PDS01ADC at SITC 2025. |
PDSB has generally reacted positively to clinical and regulatory milestones, while financing-related news has shown at least one divergence from the underlying negative dilution signal.
Over the last few months, PDSB has reported multiple clinical and regulatory milestones for PDS0101 alongside financing steps. A November earnings update highlighted VERSATILE-002 results and plans to seek an FDA meeting, followed by this Type C meeting scheduling on Dec 02, 2025 and a new Japanese patent on Dec 09, 2025. A registered direct offering and prospectus supplemented liquidity for the Phase 3 program. Historically, clinical and IP wins have aligned with positive price moves, while the offering showed a price reaction that diverged from its dilutive nature.
Regulatory & Risk Context
An effective Form S-3 filed on Aug 29, 2025 allows the company to offer up to $200.0 million of securities, including at-the-market programs and other issuances. This framework provides flexibility to raise capital for clinical programs but also highlights potential dilution via options, warrants, and convertible debentures already disclosed.
Market Pulse Summary
The stock moved +7.0% in the session following this news. A strong positive reaction aligns with PDSB’s history of responding favorably to clinical and regulatory milestones, as seen after prior trial and patent updates. This Type C meeting scheduling supports the company’s effort to use PFS as a surrogate primary endpoint for potential accelerated approval. However, investors have also faced dilution via a $200.0 million shelf capacity and recent offerings, so sustained gains have depended on balancing regulatory progress with ongoing financing needs.
Key Terms
accelerated approval regulatory
progression-free survival (PFS) medical
median overall survival (mOS) medical
surrogate primary endpoint medical
accelerated approval pathway regulatory
AI-generated analysis. Not financial advice.
Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval Pathway
PRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month.
The meeting was requested to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The request is based on positive final results from the Company’s VERSATILE-002 trial, which showed promising median overall survival (mOS) and durable progression-free survival (PFS) in patients with CPS ≥ 1. The proposed amendment to the VERSATILE-003 Phase 3 trial would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with significant statistical power, potentially forming the basis for accelerated approval of PDS0101. mOS will remain as the primary endpoint for full approval as originally recommended by FDA.
“We believe the positive PFS data from VERSATILE-002 offers an important opportunity to shorten duration to a primary endpoint and potentially accelerate our path to regulatory submission, while still preserving mOS and safety assessment as the endpoint for full FDA approval,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We are confident that the accelerated pathway we are seeking could expedite the availability of this promising treatment to patients in need, and we look forward to exploring this approach in greater detail with the FDA. We will provide further updates once we receive the FDA’s meeting minutes in January 2026.”
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
For more information, please visit www.pdsbiotech.com
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email: david.schull@russopartnersllc.com
FAQ
What will PDS Biotech discuss at the December 2025 FDA Type C meeting for PDSB?
How could the proposed VERSATILE-003 amendment affect PDSB's approval timeline?
What clinical evidence did PDSB cite to request an accelerated approval discussion?
When will investors know the FDA’s response to PDSB’s Type C meeting?
Does the proposed change remove mOS as a requirement for full approval of PDS0101 (PDSB)?
Will the December 2025 Type C meeting guarantee accelerated approval for PDSB’s PDS0101?
