PDS Biotech to Seek Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer
PDS Biotechnology Corporation (PDSB)
Last pds biotechnology corporation earnings: 11/7 06:00 am
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Source: GlobeNewswire
Company aims to shorten time frame to make PDS0101 available to patients with HPV16-positive head and neck cancer, projected to be the most dominant type of head and neck cancer in the US by mid 2030s Proposed Amendment to Ongoing VERSATILE-003 Trial to include PFS Endpoint Based Upon Final VERSATILE-002 Trial Data Showing Robust Median Progression Free Survival of 6.3 months and Increased Median Overall Survival of 39.3 months PRINCETON, N.J., Oct. 29, 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 after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration (“FDA”) to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer. The FDA meeting request is based on the final results from its VERSATILE-00
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PDSB
News
- PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)GlobeNewswire
- PDS Biotechnology (NASDAQ:PDSB) had its price target lowered by analysts at B. Riley from $5.00 to $3.00. They now have a "buy" rating on the stock.MarketBeat
- PDS Biotechnology (NASDAQ:PDSB) had its price target raised by analysts at HC Wainwright from $13.00 to $15.00. They now have a "buy" rating on the stock.MarketBeat
- PDS Biotech Reports Third Quarter 2025 Financial Results and Provides Clinical Programs UpdateGlobeNewswire
- PDS Biotechnology Q3 2025 Earnings Preview [Seeking Alpha]Seeking Alpha
PDSB
Earnings
- 11/13/25 - Beat
PDSB
Sec Filings
- 12/2/25 - Form 8-K
- 11/13/25 - Form 8-K
- 11/12/25 - Form 8-K
- PDSB's page on the SEC website