- The U.S. Food and Drug Administration (FDA) granted fast track designation to Biohaven ( NYSE: BHVN ) medicine taldefgrobep alfa to treat spinal muscular atrophy (SMA).
- SMA is an inherited motor neuron disorder characterized by loss of nerve cells leading to muscle weakness over time.
- The company noted that taldefgrobep (also known as BHV2000) had previously received received orphan drug designation from the FDA to treat SMA.
- The drug is currently undergoing a phase 3 trial dubbed RESILIENT.
- Pfizer had acquired Biohaven Pharmaceuticals but a separate company Biohaven Ltd. was spunoff before the acquisition closed.
- BHVN +1.82% to $16.81 premarket Feb. 21
For further details see:
Biohaven's spinal muscular atrophy therapy gets FDA fast track status