Theriva™ Biologics Announces Positive End-of-Phase 2 Meeting with U.S. FDA Regarding the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma

Successful meeting with FDA enables advancement into proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC – – ...
Nasdaq

Design Therapeutics Initiates Phase 1 Trial for DT-216P2; Reports Progress and Financial Results for 2024

Design Therapeutics, Inc. announced the initiation of a Phase 1 clinical trial for its gene-targeted treatment DT-216P2 in healthy volunteers, with patient dosing for Friedreich Ataxia (FA) set to ...
Nasdaq

Chemomab Therapeutics Announces FDA Alignment on Phase 3 Trial Design for Nebokitug as Potential First Treatment for Primary Sclerosing Cholangitis

Chemomab Therapeutics has announced that it has successfully completed its End-of-Phase 2 meeting with the FDA, aligning on the design of a single Phase 3 trial for its lead product candidate, ...
Cure Today

Phase 3 Study Design Finalized with FDA for IMNN-001 in Ovarian Cancer

The phase 3 OVATION 3 trial will evaluate IMNN-001's efficacy and safety in advanced ovarian cancer patients, comparing it with standard chemotherapy. Phase 2 results demonstrated a 35% improvement in ...