File investigational new drug application for Versamune MUC1
Delivered by the deadline
Under re-examination This entry has been challenged and is being re-checked against the sources.
- Announced
- 5 Feb 2025
- Due
- 30 Jun 2025
- Delivered
- January 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“File IND for Versamune® MUC1”
What we found
Evidence strength A What the grades mean
PDS Biotech filed the IND for Versamune MUC1 in January 2025, and FDA cleared it March 13, 2025, both before the Q2 2025 deadline.
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A PDS Biotech Announces FDA Clearance of IND Application for Combination of Versamune MUC1 and PDS01ADC to Treat Metastatic Colorectal Cancer States IND was filed in January 2025 and cleared by FDA March 13, 2025.
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B PDS Biotech Announces FDA Clearance of IND Application Confirms January 2025 IND filing and March 2025 FDA clearance.
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D PDS Biotech Cleared to Begin Trial of Immunotherapy Combo in MUC1-Positive Colorectal Cancer Independent news confirmation of FDA IND clearance.
Checked 12 Sep 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- File
How this entry was checked
- Commitment recordedRecorded from the company's filing.
- First checkAn AI model read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Gemini (Google), re-read the evidence without being told the outcome and reached the same answer.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2025-PDSB-000242 · Corrections policy