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Theriva Biologics, Inc. announced positive outcomes from a Type B End-of-Phase 2 meeting with the FDA on March 23, 2026, regarding the Phase 3 trial design for VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic ductal adenocarcinoma. The FDA provided general agreement on the proposed single, randomized, double-blinded trial with repeat dosing, adaptive design, and overall survival as primary endpoint, supporting a potential BLA if successful.
Event Type
Disclosure
Voluntary
Variant
8-K
and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securi
. Other Events. On March 23, 2026, the Company issued a press release announcing the outcomes of a recent Type B End-of-Phase 2 (EOP2) meeting with the FDA rega
. Financial Statements and Exhibits. (d) Exhibits. The following exhibit is furnished with this Current Report on Form 8-K. Exhibit Number Description 99.1 Pres