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Karyopharm Therapeutics Inc. reports developments tied to its commercial oncology business and selinexor-based drug development. The company markets XPOVIO (selinexor) and reports U.S. product revenue, license and other revenue, liquidity, and operating updates alongside its periodic financial results.
Recurring KPTI news also covers late-stage clinical programs evaluating selinexor in cancer indications, including the Phase 3 SENTRY trial in myelofibrosis and the Phase 3 XPORT-EC-042 trial in endometrial cancer. Company updates include clinical data presentations, regulatory-development disclosures, equity inducement grants under Nasdaq rules, financing activity, and other corporate and capital-structure matters.
Karyopharm Therapeutics (Nasdaq: KPTI) announced positive results from a Phase 1/2 study of selinexor combined with ruxolitinib for treatment-naïve myelofibrosis, showing a 75% spleen volume reduction in evaluable patients at week 12. The FDA granted Orphan Drug Designation for selinexor in treating myelofibrosis. Additionally, exploratory analyses from the SIENDO trial indicated that p53 wild-type patients with endometrial cancer had improved progression-free survival with selinexor. Findings will be presented at ASCO 2022 in Chicago from June 3-7.
Karyopharm Therapeutics (KPTI) announces the initiation of the Phase 3 study EMN29/XPORT-MM-031, focusing on an all-oral regimen of selinexor combined with pomalidomide and low-dose dexamethasone. This global study, which has begun dosing its first patient, aims to evaluate the treatment's efficacy and safety in patients with relapsed or refractory multiple myeloma. The primary endpoint is progression-free survival, with around 280 patients expected to be recruited. Top-line results are anticipated in 2024.
Karyopharm Therapeutics (Nasdaq: KPTI) announced a positive opinion from the European Medicines Agency's CHMP recommending the approval of NEXPOVIO® (selinexor) for adults with multiple myeloma who have undergone 1-3 prior therapies. This recommendation is a crucial step towards receiving marketing authorization from the European Commission, expected in about 60 days. Supported by the Phase 3 BOSTON study, the treatment demonstrated significant improvements in progression-free survival and overall response rate. The collaboration with Menarini will aid in commercialization across Europe.
Karyopharm Therapeutics (Nasdaq: KPTI) and Menarini Group announced a positive recommendation from the EMA’s CHMP for NEXPOVIO® (selinexor) in combination with bortezomib and low-dose dexamethasone for treating adult multiple myeloma patients with one to three prior therapies. This recommendation precedes a final decision from the European Commission, expected in about 60 days. The application is supported by Phase 3 BOSTON study data, showing significant improvements in progression-free survival and overall response rates compared to standard therapy.
Karyopharm Therapeutics (NASDAQ: KPTI) announced that initial data from a Phase 1 study of selinexor combined with ruxolitinib in treatment-naïve myelofibrosis patients will be presented at the EHA 2022 Congress in Vienna and the ASCO Annual Meeting. The need for innovative treatments for myelofibrosis is emphasized as current therapies are limited to JAK inhibitors. The presentation highlights the potential of selinexor in improving patient outcomes, including spleen size reduction and quality of life. Further data updates will follow at both conferences.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced participation in the 2022 RBC Capital Markets Global Healthcare Conference on May 17, 2022, at 4:35 p.m. ET in New York, NY. The company's senior management will engage in a fireside chat, with a live webcast available in the Investor section of their website. Karyopharm is noted for pioneering novel cancer therapies, including their lead SINE compound, XPOVIO®, which is approved in several oncology indications. The event will be available for replay for 90 days.
Karyopharm Therapeutics reported a strong first quarter for 2022 with net revenues of $47.7 million, a growth of 105% compared to Q1 2021. The net product revenue from XPOVIO reached $28.3 million, marking a 30% year-over-year increase. The company announced promising clinical results for selinexor in endometrial cancer and myelofibrosis, with plans for a registration-enabling study in the second half of 2022. However, Karyopharm reported a net loss of $41.4 million, but this was an improvement from a loss of $57.4 million in the prior year.
Karyopharm Therapeutics (Nasdaq: KPTI) announced the granting of stock options and restricted stock units (RSUs) to newly-hired employees and Dr. Reshma Rangwala, the new Chief Medical Officer. Dr. Rangwala received options for 100,000 shares and 65,000 RSUs, while twelve other employees received a total of 36,800 stock options and 25,400 RSUs. All awards are part of the 2022 Inducement Stock Incentive Plan and have a four-year vesting schedule. Each stock option has an exercise price of $6.10, based on the closing stock price on April 29, 2022.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) has announced that it will report its first quarter 2022 financial results on May 5, 2022, at 8:30 a.m. ET. The company's management will host a conference call to discuss the results and company updates. Karyopharm is recognized for its pioneering work in cancer therapies, particularly with its lead compound, XPOVIO® (selinexor), which is approved in the U.S. for multiple oncology indications. The company continues to expand its presence in international markets, including Europe and Asia.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) has announced that four abstracts related to selinexor clinical research will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 3-7, 2022. Key presentations include an oral study on selinexor's effects in endometrial cancer and a poster discussion on its combination with ruxolitinib for myelofibrosis. This highlights Karyopharm's commitment to innovative treatments in oncology, focusing on cancers with significant unmet needs.