Catalyst Biosciences Stock Moves Higher On Additional FDA Fast Track Tag For MarzAA
- The FDA has granted Fast Track Designation to Catalyst Biosciences Inc's (NASDAQ: CBIO) Marzeptacog alfa (activated), MarzAA, the Company's subcutaneously administered next-generation engineered coagulation Factor VIIa (FVIIa) for episodic bleeding in subjects with Factor VII deficiency.
- Catalyst is currently enrolling patients with FVII deficiency in a Phase 1/2 open-label study. The trial is conducted in parallel with the ongoing Phase 3 trial evaluating MarzAA to treat episodic bleeds in patients with Hemophilia A or B with inhibitors.
- Fast Track is an FDA process designed to facilitate and expedite the development and review of drug candidates.
- FDA granted Fast Track Designation for MarzAA for the SQ treatment and control of episodic bleeding in subjects with Hemophilia A or B with inhibitors in December 2020.
- Price Action: CBIO shares are up 2.42% at $4.65 during the premarket session on the last check Monday.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted-In: Briefs FDA Fast TrackBiotech News Penny Stocks Health Care FDA General
