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 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.