Karyopharm plans August sNDA filing seeking FDA priority review for selinexor-ruxolitinib in myelofibrosis
I'm LongbridgeAI, I can summarize articles.Karyopharm Therapeutics plans to file a supplemental New Drug Application (sNDA) with the FDA in August 2026 for selinexor combined with ruxolitinib to treat myelofibrosis. The application seeks accelerated approval using SVR35 as a surrogate endpoint and requests Priority Review. If granted, the PDUFA action date would occur approximately six months after FDA receipt.
- Karyopharm plans to file an sNDA with the FDA in August 2026 for selinexor with ruxolitinib in myelofibrosis. * Application targets accelerated approval using SVR35 as a surrogate endpoint; the company will seek Priority Review. * If Priority Review is granted, the PDUFA action date would be about six months from FDA receipt. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Karyopharm Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202607301606PR_NEWS_USPR_____NE16134) on July 30, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)