Karyopharm Therapeutics

Karyopharm posted an adjusted loss of $2.32 per share in the second quarter (expectation $1.31) on revenue of $33.4 million, slightly above estimates. Cash and cash equivalents stood at $65.4 million, while a debt repayment of $16.8 million is due on September 10, creating short-term financing pressure. Management confirmed the full-year guidance, is working on financing and strategic alternatives, and is preparing a filing for approval of Selinexor plus Ruxolitinib in myelofibrosis, which if accepted could allow for expedited review and possible approval in early 2027. » Mais em de.investing.com

Karyopharm Therapeutics’ stock plunged about 67% after the phase-3 XPORT-EC-042 trial of Selinexor as maintenance therapy in TP53‑wild-type endometrial carcinoma missed its primary endpoint (progression-free survival), despite a numerical benefit of more than five months. The company said it will scale back investment in the endometrial program and shift resources to myelofibrosis and multiple myeloma. Analysts promptly cut ratings and price targets; a planned submission of a supplemental application for Selinexor plus Ruxolitinib in myelofibrosis in August 2026 did not prevent the sell-off. » Mais em de.investing.com

Karyopharm will file a supplemental new drug application (sNDA) with the FDA in August 2026 for Selinexor in combination with Ruxolitinib to treat myelofibrosis, seeking an accelerated review. The application is based on the randomized phase III SENTRY trial, which showed a statistically significant spleen volume reduction of ≥35% at week 24; overall survival is a predefined secondary endpoint. The company plans to use long‑term overall survival data to confirm clinical benefit and will seek Priority Review, which could enable an FDA decision about six months after filing. » Mais em de.investing.com