Benzinga | Jun 28, 2021 08:45AM EDT

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.