PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint
PDS Biotechnology Corporation (PDSB)
Last pds biotechnology corporation earnings: 11/7 06:00 am
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Source: GlobeNewswire
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 20
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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
- 1/9/26 - Form 8-K
- 12/12/25 - Form S-8
- 12/9/25 - Form 8-K
- PDSB's page on the SEC website