Biohaven's Taldefgrobep Alfa Receives EU Orphan Drug Designation For Spinal Muscular Atrophy
Portfolio Pulse from Happy Mohamed
Biohaven Ltd. (NYSE:BHVN) has received orphan medicinal product designation from the European Commission for taldefgrobep alfa, a treatment for spinal muscular atrophy (SMA). The designation provides regulatory and commercial incentives, including reduced regulatory fees and an additional ten years of market protection. The drug is currently in Phase 3 clinical development and has previously received Fast Track and Orphan Drug Designation in the US.
July 31, 2023 | 1:34 pm
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Biohaven's taldefgrobep alfa has received EU Orphan Drug Designation, which could provide commercial and regulatory benefits. The drug is in Phase 3 development for SMA treatment.
The EU Orphan Drug Designation for taldefgrobep alfa could provide Biohaven with commercial and regulatory benefits, including reduced regulatory fees and an additional ten years of market protection. This could potentially accelerate the drug's path to market and increase its profitability, which could have a positive impact on Biohaven's stock price in the short term.
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