PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint

Rhea-AI Summary

PDS Biotech (NASDAQ: PDSB) submitted a protocol amendment to the FDA on Jan 9, 2026 to change the Phase 3 VERSATILE-003 trial's primary endpoint to progression-free survival (PFS), enabling earlier evaluation with significant statistical power and potentially supporting an accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer. Median overall survival (mOS) and safety remain required for full FDA approval. The amendment follows a constructive Type C meeting with the FDA in December 2025 and is supported by positive final VERSATILE-002 results reporting promising mOS and durable PFS.

Positive

• Constructive FDA Type C meeting held in December 2025
• Protocol amendment seeks PFS as earlier primary endpoint
• VERSATILE-002 final results showed promising mOS and durable PFS

Negative

• Median overall survival remains required for full FDA approval
• Accelerated approval based on PFS is a potential, not guaranteed, pathway

Key Figures

Trial phase Phase 3 VERSATILE-003 trial stage for PDS0101

Type C meeting date December 2025 Timing of FDA Type C meeting supporting endpoint change

Press release date Jan 09, 2026 Announcement of FDA alignment on PFS endpoint

Market Reality Check

$1.07 Last Close

Volume Volume 902,694 is 1.81x the 20-day average of 499,319, indicating elevated interest ahead of the trial amendment. high

Technical Shares at 0.9933 are trading below the 200-day MA of 1.14 and remain 54.85% under the 52-week high.

Peers on Argus

PDSB gained 4.23% while close peers were mostly down (e.g., CUE -1.78%, PYPD -5.87%, VTVT -3.39%), with only MAIA modestly higher (+1.22%), pointing to stock-specific reaction to the FDA endpoint alignment.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 09	IP / patent win	Positive	+18.0%	New Japanese composition-of-matter patent expands global PDS0101 protection.
Dec 02	Regulatory meeting set	Positive	+7.0%	FDA accepted Type C meeting to discuss PFS-based accelerated approval pathway.
Nov 13	Earnings & clinical update	Negative	-12.3%	Reported net loss and cash use alongside VERSATILE-002 data and planned FDA request.
Nov 11	Dilutive equity offering	Negative	+8.8%	Registered direct offering with warrants to fund VERSATILE-003 and corporate needs.
Nov 10	Clinical data update	Positive	+7.0%	SITC 2025 data showed strong immune and clinical activity for PDS0101 and PDS01ADC.

Pattern Detected

Clinical and IP milestones have often triggered positive moves, while financing news has occasionally produced divergent reactions, suggesting sensitivity to both development progress and dilution risk.

Recent Company History

Over the past few months, PDSB has advanced PDS0101 through key milestones. On Nov 10, it reported positive translational data, followed by a registered direct offering on Nov 11 to fund VERSATILE‑003. Q3 results on Nov 13 highlighted strong VERSATILE‑002 survival data but ongoing losses. In early December, the company secured a Type C FDA meeting about using PFS as a surrogate primary endpoint, and on Dec 09 it expanded patent protection for PDS0101 in Japan. Today’s protocol amendment reflects follow‑through on that regulatory strategy.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-08-29

$200.0 million registered capacity

An effective Form S-3 shelf filed on Aug 29, 2025 allows PDSB to offer up to $200.0 million of securities, including up to $20.0 million via a dedicated sales agreement and a separate ATM facility of up to $50.0 million, of which $5.7 million has been used. This framework enables additional capital raises that could dilute existing shareholders.

Market Pulse Summary

This announcement reflects FDA alignment on using progression free survival as a primary endpoint in the Phase 3 VERSATILE‑003 trial, potentially enabling an accelerated approval route while preserving median overall survival for full approval. It follows prior VERSATILE‑002 data and a December 2025 Type C meeting. Investors may watch for protocol acceptance, enrollment progress, and any subsequent financing activity under the existing $200.0 million shelf as the program advances.

Key Terms

progression free survival medical

"changes the PFS endpoint to a primary endpoint that can be evaluated earlier"

Progression free survival is the length of time during and after a treatment when a disease, such as cancer, does not get worse or spread. It is an important measure because longer periods of stability can indicate that a treatment is effectively controlling the condition. For investors, it provides insight into the potential durability and success of a therapy or medication.

median overall survival medical

"Median overall survival (mOS) remains the primary endpoint for full approval"

Median overall survival is the middle point of how long patients live after starting treatment, meaning half live longer and half live shorter. It helps doctors understand how effective a treatment is and gives patients an idea of what to expect about their future.

accelerated approval regulatory

"provides Potential Pathway to Accelerated Approval of PDS0101"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

phase 3 medical

"for its Phase 3 VERSATILE-003 clinical trial"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

u.s. food & drug administration regulatory

"submitted a protocol amendment to the U.S. Food & Drug Administration (“FDA”)"

The U.S. Food & Drug Administration (FDA) is the federal agency that reviews and approves medicines, medical devices, vaccines, food safety measures and related health products for use in the United States. Investors watch FDA decisions because approvals, rejections or safety warnings can quickly change a company’s sales prospects and stock value—similar to a referee’s call that can determine whether a product can legally enter the market and compete.

AI-generated analysis. Not financial advice.

PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 Trial

Constructive Type C Meeting Provides Potential Pathway to Accelerated Approval of PDS0101

PRINCETON, N.J., Jan. 09, 2026 (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 the Company has submitted a protocol amendment to the U.S. Food & Drug Administration (“FDA”) for its Phase 3 VERSATILE-003 clinical trial. The proposed amendment to the VERSATILE-003 Phase 3 trial changes the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power, potentially providing the basis for accelerated approval of PDS0101. Median overall survival (mOS) remains the primary endpoint for full approval as originally recommended by FDA.

The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The amendment is supported by positive final results from the Company’s VERSATILE-002 trial, which showed promising mOS and durable PFS.

“Submission of the amended protocol is an exciting next step in our mission to make this promising treatment available to patients in need,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We believe that including PFS as a primary endpoint offers an important opportunity to shorten the duration of VERSATILE-003. The amendment retains mOS and safety as requirements for full FDA approval, and based on the dialogue we had with the agency in December, we are confident that we have a pathway to potentially accelerate our regulatory submission.”

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:
Jude Gorman / Kiki Torpey
Collected Strategies
PDS-CS@collectedstrategies.com

FAQ

What did PDSB announce on January 9, 2026 about VERSATILE-003?

PDSB submitted a protocol amendment to make PFS the primary endpoint to enable earlier evaluation and potential accelerated approval.

How does the January 2026 amendment affect PDS0101 approval requirements for PDSB?

The amendment targets accelerated approval via PFS while keeping mOS and safety as requirements for full FDA approval.

What regulatory interaction preceded PDSB's VERSATILE-003 amendment?

A constructive Type C meeting with the FDA was held in December 2025 to discuss the proposed accelerated approval pathway.

Why is PFS being proposed as the primary endpoint for VERSATILE-003?

PFS can be evaluated earlier with significant statistical power, potentially shortening trial duration and enabling accelerated approval.

What clinical data supports PDSB's amendment to VERSATILE-003?

The amendment is supported by VERSATILE-002 final results, which showed promising median overall survival and durable PFS.