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.
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Karyopharm Therapeutics (Nasdaq: KPTI) announced promising results from a Phase 1 study on selinexor combined with ruxolitinib in treatment-naïve myelofibrosis patients. At Week 24, the 60mg dose achieved a 92% SVR35 and 78% TSS50 in the efficacy evaluable population, with 79% SVR35 and 58% TSS50 in the intent-to-treat population. The safety profile was generally tolerable, with common adverse effects like nausea and anemia. Karyopharm is planning to initiate a pivotal Phase 3 study in the first half of 2023 to further explore this combination therapy. Investor interest is high, with a webcast featuring key opinion leader Dr. John Mascarenhas discussing the study's implications. These results could potentially transform treatment options for myelofibrosis.
Karyopharm Therapeutics (NASDAQ: KPTI) announces the presentation of updated data from its Phase 1 study on selinexor, combined with ruxolitinib, to treat treatment-naïve myelofibrosis. These findings will be showcased at the AACR Annual Meeting 2023 in Orlando, Florida, on April 18, 2023. The study's poster session will cover 12 and 24-week data across all patients, including the recommended dose. Additionally, Karyopharm will host an investor webcast on the same day at 4:30 p.m. ET, featuring a key opinion leader discussing the therapy's potential and the unmet medical need in this patient population. Selinexor, marketed as XPOVIO, is a pioneering treatment in the field of oncology, having received regulatory approvals in various countries for multiple cancer indications.
Karyopharm Therapeutics (Nasdaq: KPTI) announced on April 3, 2023, the grant of 221,900 restricted stock units (RSUs) to thirteen new employees, effective March 31, 2023. The RSUs will vest over three years, with one-third vesting annually. Additionally, Senior VP Tahira Payne received 60,000 RSUs, vesting at 25% each year for four years. These equity awards comply with the 2022 Inducement Stock Incentive Plan and Nasdaq Listing Rule 5635(c)(4). The vesting of awards is contingent on ongoing employment, with provisions for immediate vesting upon certain terminations of employment.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced that results from its Phase 1 study on selinexor combined with ruxolitinib for treatment-naïve myelofibrosis will be presented at the AACR Annual Meeting 2023. The combination therapy showed potential efficacy, with updates indicating a ≥35% reduction in spleen volume and a ≥50% reduction in symptom scores among 24 patients followed for 24 weeks. Safety data demonstrated the combination was generally well tolerated. An investor webcast is planned to discuss the study results, emphasizing the potential impact of XPO1 inhibition in myelofibrosis treatment.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a leader in cancer therapies, will participate in a fireside chat at the Barclays Global Healthcare Conference on March 15 at 4:35 p.m. ET. The event will feature insights from the company’s senior management team. Investors can access a live webcast and accompanying slides on the company’s Investor website, with a replay available for 90 days post-event. Karyopharm is known for its pioneering SINE compound technology and its lead product, XPOVIO®, which is approved in multiple oncology indications.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) announced the appointment of Tanya Lewis to its board of directors, effective March 1, 2023. With over 25 years in drug development, Ms. Lewis has a proven track record, having held leadership roles at Replimune Group and Karyopharm Therapeutics. Her experience includes overseeing the approval of several new drugs, including XPOVIO®. The board welcomed her expertise at a pivotal time for DiaMedica as they work to address the clinical hold on their ReMEDy2 AIS trial. Ms. Lewis aims to support the company’s mission of providing treatment options for stroke patients.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced the granting of 111,250 restricted stock units (RSUs) to eight new employees as part of its 2022 Inducement Stock Incentive Plan on February 28, 2023. The RSUs will vest over three years with one-third vesting on each anniversary of employment. If a change in control event occurs, the RSUs can be exercised if employment is terminated for good reason or without cause. Karyopharm specializes in innovative cancer therapies, notably its lead XPO1 inhibitor, XPOVIO®, which is approved in various regions for multiple oncology indications.
Karyopharm Therapeutics (Nasdaq: KPTI) and Menarini Group announced that the UK's Medicines and Healthcare Products Regulatory Agency has granted full Marketing Authorization for NEXPOVIO® (selinexor) in combination with bortezomib and dexamethasone for treating adult patients with multiple myeloma who have had at least one prior therapy. This authorization converts the previous conditional approval to full status, based on results from the Phase 3 BOSTON study that showed significant improvements in disease progression. The Menarini Group will handle commercialization in the UK.
Karyopharm Therapeutics reported total revenue of $157.1 million for 2022, with U.S. XPOVIO® net product revenue of $120.4 million, meeting company guidance. The fourth quarter saw a 4% increase in net product revenue year-over-year. For 2023, the company anticipates total revenue between $160 million and $175 million, including U.S. XPOVIO projections of $125 million to $140 million. Cash reserves are expected to sustain operations until late 2025. The company also revealed advancements in its clinical pipeline, including key studies in myelofibrosis and myelodysplastic neoplasms, with interim data expected in the first half of 2023.