CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
17 Apr 2024: BiVictriX Therapeutics AML treatment granted Orphan Drug status by FDA
- BiVictriX Therapeutics drug, BVX001, receives an Orphan Drug Designation (ODD) from the FDA to address a significant unmet medical need in AML treatment
- The company successfully concluded an Initial Targeted Engagement for Regulatory Advice (INTERACT) meeting with the FDA, receiving favorable guidance aligning with its developmental strategy for BVX001
- BiVictriX plans to advance its preclinical data package for BVX001, aiming to submit a pre-IND application and present further efficacy and safety data at a key Haematology Conference in the second half of 2024
- ODD offers benefits such as tax credits and market exclusivity post-approval, potentially aiding BiVictriX in commercializing BVX001
