Biohaven: FDA Grants Fast Track Designation For Taldefgrobep Alfa In Treatment Of SMA

(RTTNews) - Biohaven Ltd. (BHVN) announced it received Fast Track designation from the FDA for taldefgrobep alfa, an anti-myostatin adnectin, for the treatment of spinal muscular atrophy. Biohaven previously received orphan drug designation from the FDA for taldefgrobep in the treatment of SMA. The company is currently enrolling a Phase 3 clinical trial of taldefgrobep in SMA.

Taldefgrobep alfa is a modified adnectin designed to specifically bind to myostatin. It is a fully human anti-myostatin recombinant protein that lowers free myostatin and acts as an Activin 2b receptor antagonist with the myostatin-taldefgrobep complex.

Shares of Biohaven are up 2% in pre-market trade on Tuesday.

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