FDA Approves Scholar Rock's Isembyld for SMA, Shares Surge 12%
SRRK has more than doubled off its 52-week low of $27.07.
Summary
The FDA approved Isembyld (apitegromab) for spinal muscular atrophy in patients aged 2 and older, making it the first muscle-targeted SMA therapy. Shares jumped 12% in extended trading as the company transitions to commercial stage. The broad label and rare pediatric disease priority review voucher add upside. Commercial launch is underway with shipments expected in days; an investor call Monday at 8 a.m. ET will detail pricing and rollout. This follows the September 11 approval announcement and builds on the positive Phase 3 SAPPHIRE data.
At the time of this announcement, SRRK was trading at $61.97 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6.7B. The 52-week trading range was $27.07 to $61.76. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Seeking Alpha.