Antengene Corporation's XPOVIO® has received approval for reimbursement in South Korea for multiple myeloma, benefiting more patients in the region.

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Karyopharm Therapeutics has submitted a supplemental New Drug Application for its therapy combining XPOVIO and Ruxolitinib, aiming to treat myelofibrosis patients. This move highlights both urgency and promise.

Reported Monday, Aug 31 - 7:32am EDT (TheFly subscription required to read more.)

Karyopharm Therapeutics (Nasdaq: KPTI) has submitted a supplemental New Drug Application (sNDA) to the U.S. FDA seeking Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib to treat patients with myelofibrosis. The company has also requested Priority Review, which, if granted, could shorten FDA review to six months.According to Karyopharm, the sNDA is supported in part by Phase 3 SENTRY trial data in JAK inhibitor–naïve myelofibrosis patients (N=353), using spleen volume reduction ≥35% at week 24 and symptom score change as co‑primary endpoints. The company expects to receive FDA filing acceptance and timeline information in Q4 2026 and plans to use long‑term overall survival data from SENTRY as confirmatory evidence for potential conversion from accelerated to traditional approval. Selinexor already holds U.S. and EU orphan designations for myelofibrosis and a U.S. Fast Track designation.

Click to view the official SEC document.

– sNDA Submitted under the Accelerated Approval Pathway; Priority Review Requested – NEWTON, Mass., Aug. 31, 2026 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has submitted...

Karyopharm (Nasdaq: KPTI) reported second quarter 2026 total revenue of $33.4 million, including $30.8 million in U.S. XPOVIO net product revenue and $2.6 million in license and other revenue. Royalty revenue from partners rose to $2.5 million, reflecting broader ex-U.S. selinexor access.The company remains on track to submit an August 2026 sNDA for selinexor plus ruxolitinib in myelofibrosis under the FDA Accelerated Approval pathway and plans to request Priority Review, supported by Phase 3 SENTRY data. Karyopharm reaffirmed 2026 total revenue guidance of $130–$150 million and U.S. XPOVIO guidance of $115–$130 million, while guiding 2026 R&D and SG&A expenses of $230–$245 million.Second quarter 2026 loss from operations was $22.5 million, with a net loss of $67.0 million. Cash, cash equivalents, restricted cash and investments totaled $65.4 million at June 30, 2026. The company is actively evaluating financing and strategic alternatives amid a $15.8 million September 10, 2026 term-loan payment and a $10.0 million minimum liquidity covenant.

Karyopharm shares crater 65% after Xpovio fails Phase 3 endometrial cancer trial; company pivots to myelofibrosis label bid.

Selinexor Tablets (brand: XPOVIO®) are first-in-class SINE (Selective Inhibitor of Nuclear Export) compounds used in experimental oncology research. Each box contains twelve 20 mg film-coated tablets. Manufactured by Catalent CTS, LLC (USA), registered under NMPA No. HJ20210083 / Code 86983951000018.⚠️ For laboratory research use only.（Please consult the staff for other purposes）

- XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia. - From the second half of 2024 to now, XPOVIO® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene's commercial presence in APAC. To date,…

XPOVIO® is the first XPO1 inhibitor approved in Taiwan for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM). After the mainland of China, South Korea, Australia and Singapore, Taiwan market is the fifth APAC market in…

– XPOVIO® (selinexor) has received approvals for three indications in Hong Kong. These include its previous approval as the treatment for multiple myeloma (MM) when used together with dexamethasone (Xd), and its recent approvals as a monotherapy for relapsed or refractory diffuse large B-cell lymphoma (R/RDLBCL) and as a combination therapy when used together with […]

Oakville, Ontario--(Newsfile Corp. - November 18, 2025) - FORUS Therapeutics is pleased to announce that XPOVIO® (selinexor) is publicly funded in Quebec for the treatment of multiple myeloma as of November 6, 2025. Please see the following link for full funding criteria: Liste des médicaments fournis en établissement | Régie de l'assurance maladie du Québec (RAMQ) (https://www.ramq.gouv.qc.ca/fr/a-propos/liste-medicaments fournis-etablissement) and Liste des médicaments | Régie de l'assurance...

Despite hitting just one of two efficacy endpoints in a pivotal trial, Karyopharm thinks it still has a path to approval for Xpovio in myelofibrosis

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