Welcome to our dedicated page for Karyopharm Therapeutics news (Ticker: KPTI), a resource for investors and traders seeking the latest updates and insights on Karyopharm Therapeutics stock.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company focused on novel cancer therapies that target nuclear export dysregulation. Its lead product, XPOVIO (selinexor), is a first-in-class, oral exportin 1 (XPO1) inhibitor approved in the U.S. in multiple oncology indications and in various indications across more than 50 ex-U.S. territories and countries, according to company statements.
This news page aggregates company-issued updates and market disclosures related to Karyopharm. Readers can follow announcements on XPOVIO commercial performance, such as reported U.S. net product revenue and trends in license and royalty revenue from international partners, as described in the company’s earnings releases. The feed also covers progress in Karyopharm’s clinical pipeline, including multiple myeloma, endometrial cancer, myelofibrosis and diffuse large B-cell lymphoma (DLBCL).
Recent news has highlighted key milestones in late-stage development, including completion of enrollment in the Phase 3 SENTRY trial (XPORT-MF-034) in myelofibrosis and ongoing enrollment in the global Phase 3 XPORT-EC-042 trial in TP53 wild-type advanced or recurrent endometrial cancer. Company releases also describe Phase 2 data in heavily pretreated myelofibrosis patients and the design of additional studies such as SENTRY-2 and XPORT-MM-031 in multiple myeloma.
In addition to clinical and commercial updates, Karyopharm’s news includes financial results, preliminary revenue disclosures, strategic financing transactions involving term loans and convertible notes, and inducement equity awards granted under its inducement stock incentive plan. Investors and observers can use this page to review the company’s own descriptions of its operational progress, financing activities and anticipated clinical catalysts as reported in press releases and referenced in SEC filings.
Karyopharm Therapeutics (KPTI) announced positive results from the Phase 2b SADAL study, assessing XPOVIO (selinexor) for relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL). The study reported an overall response rate of 28%, with a complete response rate of 12%. Notably, the median duration of response was 9.3 months. FDA approved XPOVIO for this indication on June 22, 2020, under the Accelerated Approval Program. A European submission is planned for 2021, further extending its market potential.
Karyopharm Therapeutics announced FDA approval for XPOVIO® (selinexor), now the only single-agent oral therapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This first-in-class drug also holds the distinction of being the only FDA-approved treatment for both DLBCL and multiple myeloma. The approval comes under the FDA’s Accelerated Approval Program, based on a 29% overall response rate in clinical studies. XPOVIO will be available immediately in the U.S., with plans for a European submission in 2021. Continued approval depends on further clinical trials to confirm its benefits.
Karyopharm Therapeutics (KPTI) announced the presentation of eight posters on XPOVIO (selinexor) and eltanexor at the EHA 2020 Virtual Annual Meeting from June 11-21, 2020. Key findings include a 9-month median overall survival in relapsed/refractory DLBCL patients treated with selinexor, demonstrating significant efficacy over historical controls. Additional analyses show durable responses across treatment histories. Eltanexor data highlights potential effectiveness against NPM1-mutated AML and predictive molecular markers for multiple myeloma responses. The FDA's decision on KPTI's supplemental application is expected later this month.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced the grant of stock options for 25,800 shares to seven new employees, effective May 29, 2020. This grant, in accordance with Nasdaq rules, serves as an employment inducement. Each option has an exercise price of $18.49 and will vest over four years. Notably, options can be exercised in full if employment ends without cause within a year following a change in control. Karyopharm focuses on innovative drugs targeting nuclear export for cancer treatments, with ongoing regulatory processes for its lead drug, XPOVIO.
Karyopharm Therapeutics (KPTI) announced significant results from the Phase 3 BOSTON study, which evaluated the once-weekly regimen of XPOVIO (selinexor), Velcade (bortezomib), and dexamethasone (SVd) in multiple myeloma patients. The study revealed a 47% increase in median progression-free survival (PFS) compared to the standard treatment. Additionally, SVd demonstrated superior overall response rates and lower rates of peripheral neuropathy. A supplemental New Drug Application has been submitted to the FDA for XPOVIO's approval as a new treatment option.
Karyopharm Therapeutics (Nasdaq: KPTI) has announced that CEO Michael Kauffman will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 2, 2020, at 9:30 a.m. ET. A live webcast of the chat will be available on the company's investor website, with a replay accessible for 90 days. Karyopharm is focused on developing innovative pharmaceuticals targeting nuclear export for cancer treatment. Their lead drug, XPOVIO®, received FDA approval in July 2019 and is part of ongoing clinical trials.
Karyopharm Therapeutics (KPTI) announced a conference call on May 29, 2020, to discuss results from the pivotal Phase 3 BOSTON study, which evaluated XPOVIO (selinexor) combined with Velcade and low-dose dexamethasone in multiple myeloma patients. The study met its primary endpoint, showing a significant increase in progression-free survival compared to the standard treatment. The results will be presented at the ASCO 2020 Virtual Scientific Program. Karyopharm has submitted a supplemental New Drug Application for XPOVIO based on these promising findings.
Karyopharm Therapeutics (Nasdaq: KPTI) announced that CEO Michael Kauffman will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on May 19, 2020, at 8:35 a.m. ET. A live webcast will be available on their website, with a replay accessible for 90 days post-event. Karyopharm focuses on developing novel drugs targeting nuclear export for cancer treatment. Their lead drug, XPOVIO (selinexor), received FDA accelerated approval in July 2019 for multiple myeloma and is under review in Europe and for additional indications.
Karyopharm Therapeutics reported a strong first quarter of 2020, with net product sales of $16.1 million and total revenues of $18.1 million. The pivotal Phase 3 BOSTON Study achieved its primary endpoint, showing a 47% increase in progression-free survival for patients on XPOVIO compared to standard therapy. Karyopharm plans to submit a supplemental New Drug Application to the FDA by the end of May for expanded use of XPOVIO in multiple myeloma. Additionally, the FDA accepted an sNDA for selinexor in DLBCL, granting priority review, with a PDUFA action date set for June 23, 2020.
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