PDS Biotechnology Corp
PDS0101
HPV16-positive recurrent and/or metastatic Head and Neck Cancer
Date
TBD
FDA decision · Date TBD estimated
What's at stake
The FDA's approval decision on PDS0101 for HPV16-positive recurrent and/or metastatic Head and Neck Cancer is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 14h ago
“The submission follows a constructive Type C meeting held with the FDA in December 2025 to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer.”