Theriva™ Biologics Announces U.S. FDA Guidance on Design of Phase 3 Study of VCN-01 for the Treatment of Metastatic Pancreatic Cancer [Yahoo! Finance]
Theriva Biologics, Inc. (TOVX)
Company Research
Source: Yahoo! Finance
designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent Type D meeting with the U.S. Food and Drug Administration (FDA) to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC). The Company recently announced the completion of target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combination with gemcitabine/nab-paclitaxel as a first line therapy for PDAC patients. Type D meetings are focused on a narrow set of issues that are used to discuss issues at key decision points to provide timely feedback critical to moving a drug development program forward. The FDA advised that the on-going VIRAGE Phase 2b study should not be expanded into a Phase 3 study; rather, the optimal path forward for the VCN-01 PDAC program is to conduc
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News
- Theriva™ Biologics Announces U.S. FDA Guidance on Design of Phase 3 Study of VCN-01 for the Treatment of Metastatic Pancreatic CancerGlobeNewswire
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- Theriva Biologics GAAP EPS of -$6.81 [Seeking Alpha]Seeking Alpha
- Theriva™ Biologics Reports Third Quarter 2024 Operational Highlights and Financial ResultsGlobeNewswire
- Theriva Biologics Selected as Finalist in International Competition for Merck KGaA's EMEA Advance Biotech GrantGlobeNewswire
TOVX
Analyst Actions
- 11/13/24 - Maxim Group
TOVX
Sec Filings
- 12/10/24 - Form S-1
- 12/5/24 - Form 8-K
- 11/20/24 - Form S-8
- TOVX's page on the SEC website