PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
PDS Biotechnology Corporation (PDSB)
Last pds biotechnology corporation earnings: 11/7 06:00 am
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Source: GlobeNewswire
PRINCETON, N.J., Feb. 05, 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 reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year. PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune® HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical re
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News
- PDS Biotech Announces New Composition of Matter Patent for PDS0101 in JapanGlobeNewswire
- 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
PDSB
Earnings
- 11/13/25 - Beat
PDSB
Sec Filings
- 12/12/25 - Form S-8
- 12/9/25 - Form 8-K
- 12/2/25 - Form 8-K
- PDSB's page on the SEC website