Blood Cancer Drug Misses Key Trial Endpoint, Karyopharm Shares Drop 16%
KPTI sits 59% above its 52-week low of $3.51 on elevated volume (19× avg).
Summary
Karyopharm Therapeutics announced disappointing late-stage clinical trial results for its myelofibrosis treatment, a combination of selinexor and ruxolitinib, which missed one of its primary endpoints. The study failed to demonstrate a statistically significant improvement in absolute total symptom score, leading to a 16% decline in the company's stock. While the trial did meet its other primary endpoint of spleen-volume reduction, analysts believe the missed endpoint significantly diminishes the likelihood of FDA approval, especially given regulators' focus on total symptom score superiority. This setback adds to the company's challenges, following a recent 'going concern' warning and previous clinical program setbacks, despite a recent $30 million private placement. Investors will now closely watch Karyopharm's upcoming discussions with the FDA regarding the data and its supplemental new drug application filing plan.
At the time of this announcement, KPTI was trading at $5.57 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $102.2M. The 52-week trading range was $3.51 to $10.99. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.