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Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company focused on pioneering novel cancer therapies. The company specializes in the discovery, development, and commercialization of drugs targeting nuclear export proteins for the treatment of cancer and other significant diseases. Its flagship product, XPOVIO® (selinexor), is a first-in-class, oral exportin 1 (XPO1) inhibitor and is approved in the U.S. for multiple oncology indications. These include combination therapies with Velcade® (bortezomib) and dexamethasone for multiple myeloma, as well as treatments for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Recent achievements highlight the company's commitment to advancing its late-stage clinical pipeline. Notably, Karyopharm has been at the forefront in evaluating selinexor's efficacy in combination therapies for multiple myeloma, endometrial cancer, and myelofibrosis. The company recently reported long-term follow-up data from a Phase 1/3 study on selinexor in combination with ruxolitinib in myelofibrosis patients, showing promising results in spleen volume and symptom reduction.
Financially, Karyopharm reported total revenue of $33.7 million for Q4 2023, with a full-year revenue of $146.0 million. Despite a competitive market, the company managed to maintain steady growth and focused resources on its high-potential pipeline. With a cash position of $192.4 million as of December 31, 2023, Karyopharm is well-positioned to continue its innovative research and development efforts.
Karyopharm's collaborations with global partners, including Antengene, Menarini, Neopharm, and FORUS, have extended the reach of XPOVIO to various international markets such as Europe, China, South Korea, and Israel. This international expansion underscores the global demand for innovative cancer therapies.
For more information, please visit www.karyopharm.com.
Karyopharm Therapeutics (Nasdaq: KPTI) announced that the European Commission has granted full Marketing Authorisation for NEXPOVIO® (selinexor) to treat adults with multiple myeloma after at least one prior therapy. This approval follows a positive opinion from the CHMP based on the Phase 3 BOSTON study, demonstrating that the combination of NEXPOVIO with bortezomib and dexamethasone significantly reduces disease progression risk. The indication is effective across all EU member states and other territories. Karyopharm aims to enhance patient access to this treatment.
Karyopharm Therapeutics (KPTI) announced that its investigational drug, eltanexor, received FDA Fast Track designation and European Orphan Medicinal Product designation for the treatment of myelodysplastic syndromes (MDS). This signifies a crucial need for new therapies for patients with relapsed or refractory MDS, which currently lacks approved treatments. About 15,000 and 14,000 individuals in the U.S. and EU, respectively, are projected to be diagnosed with high-risk MDS in 2022. The fast track process aims to expedite drug development, while orphan designation allows for various incentives.
Karyopharm Therapeutics (Nasdaq: KPTI) announced the approval of stock options for 32,600 shares and 22,400 restricted stock units (RSUs) to 11 new employees, effective June 30, 2022. These grants serve as inducements for their employment, in compliance with Nasdaq Listing Rule 5635(c)(4). The stock options, priced at $4.51, will vest over four years, with 25% vesting after one year and the remainder monthly. RSUs will vest similarly over four years. Each award can be exercised fully if employment ends for 'good reason' or is terminated without 'cause' within the first year after a change in control.
Karyopharm Therapeutics (Nasdaq: KPTI) announced the grant of stock options for 136,700 shares and 90,700 restricted stock units (RSUs) to 18 newly hired employees as of May 31, 2022. This is part of the Company's 2022 Inducement Stock Incentive Plan, aligning with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $6.28 per share and will vest over four years. The RSUs will also vest over four years, with 25% vesting annually. These awards incentivize talent acquisition in the competitive pharmaceutical industry.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) will participate in a fireside chat at the Jefferies Healthcare Conference on June 9, 2022, at 9:30 a.m. ET, in New York, NY. The event will feature the senior management team and will be accessible via live webcast on the company's Investor website, with replays available for 90 days after the conference. Karyopharm specializes in innovative cancer therapies, including its XPOVIO® (selinexor), which targets various high unmet cancer needs.
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.