- The company requested a meeting with the FDA to discuss an accelerated approval pathway for its lead cancer drug, PDS0101, following strong final data from its VERSATILE-002 trial.
- The proposal includes amending the ongoing VERSATILE-003 Phase 3 study to add progression-free survival as an earlier primary endpoint, potentially allowing for an earlier submission.
- Retail traders on Stocktwits flooded discussions with optimism, calling the stock “too cheap” and speculating that the FDA could grant early approval to give patients faster access to the therapy.
Shares of PDS Biotechnology logged their best session in more than two months after the late-stage immunotherapy company said it has requested a meeting with the U.S. Food and Drug Administration to discuss an expedited approval pathway for PDS0101, its lead candidate in HPV16-positive head and neck cancer.
FDA Meeting Request
The company said the request follows a review of the final VERSATILE-002 trial data and a proposal to amend the ongoing VERSATILE-003 Phase 3 study. The amendment would reduce the number of patients while maintaining statistical power and add progression-free survival (PFS) as an earlier primary endpoint, alongside median overall survival (mOS).
If the PFS endpoint is met, it could allow for an accelerated approval submission to the FDA. While the amendment is under review, the VERSATILE-003 trial will be temporarily paused, though treatment for currently enrolled patients will continue.
Almost 40 Months Of Median Survival
CEO Frank Bedu-Addo said the final survival results from VERSATILE-002 were “very exciting,” noting that it was the first trial in the recurrent or metastatic head and neck cancer population to show a median overall survival of almost 40 months. He added that seeking to include PFS as an earlier primary endpoint could shorten the trial duration.
Chief Medical Officer Kirk Shepard said the company’s goal is to pursue the fastest and most cost-effective regulatory path for approval and to provide a non-chemotherapy option for patients who currently lack effective therapies.
Trial Background
VERSATILE-002 is an open-label, multi-center Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive head and neck cancer.
On Stocktwits, retail sentiment for PDS Biotechnology was ‘extremely bullish’ amid a 2,333% surge in 24-hour message volume.
Stocktwits Bulls Bet On Early FDA Nod
One user said the news was “very good” and that the stock looked “way too cheap,” suggesting they were watching for more upside.
Another user speculated that the FDA might allow an early approval if PDS agreed to continue trials at the same time, calling it a move that could give very sick head and neck cancer patients access to a potentially life-saving therapy.
PDS Biotechnology’s stock has declined 38% so far in 2025.
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