Biohaven Gets FDA Fast-Track Tag for Taldefgrobep in Spinal Muscular Atrophy
22 February 2023 - 12:16AM
Dow Jones News
By Colin Kellaher
Biohaven Ltd. on Tuesday said the U.S. Food and Drug
Administration granted fast-track designation to taldefgrobep alfa
for the treatment of spinal muscular atrophy, a rare and
progressively debilitating motor-neuron disease.
The New Haven, Conn., clinical-stage biopharmaceutical company
said taldefgrobep has the potential to be a novel therapy to be
used in combination with disease-modifying therapies to enhance
muscle function by blocking activity of myostatin, naturally
occurring protein that limits skeletal muscle growth.
The FDA's fast-track program is designed to facilitate the
development and expedite the review of treatments for serious or
potentially life-threatening illnesses with high unmet medical
needs.
Biohaven previously received FDA orphan-drug designation, which
gives special status to drugs and biologics for diseases and
disorders that affect fewer than 200,000 people in the U.S., for
taldefgrobep in spinal muscular atrophy.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 21, 2023 08:01 ET (13:01 GMT)
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