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 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 National Comprehensive Cancer Network (NCCN) has added three XPOVIO (selinexor) combination regimens to its Clinical Practice Guidelines for previously treated multiple myeloma. The regimens include SVd (selinexor/bortezomib/dexamethasone), SDd (selinexor/daratumumab/dexamethasone), and SPd (selinexor/pomalidomide/dexamethasone). Notably, the SVd regimen received a Category 1 recommendation, the NCCN's highest designation. Additionally, Karyopharm's supplemental New Drug Application for XPOVIO in this indication has an FDA action date of March 19, 2021.
Karyopharm Therapeutics (Nasdaq: KPTI) presented promising data from a Phase 2 study of XPOVIO® (selinexor) at the ASH 2020 Annual Meeting. This study evaluated the combination of XPOVIO with standard chemotherapy in older adults with acute myeloid leukemia (AML). Results indicated that the XPOVIO arm had a median overall survival of 839 days compared to 265 days for the standard arm (p=0.0472). The overall response rate was significantly higher at 86% versus 43%. Adverse events were manageable, with diarrhea and thrombocytopenia being the most common. Further evaluations are anticipated.
Karyopharm Therapeutics Inc. (KPTI) announced over twenty presentations for XPOVIO® at the virtual ASH 2020 Annual Meeting. Key highlights include updated data from the STOMP study, showcasing durable responses in multiple myeloma patients. The Phase 3 BOSTON study subgroup analyses revealed significant progression-free survival (PFS) benefits across various patient categories, including those naive to proteasome inhibitors. A supplemental New Drug Application for XPOVIO is under FDA review with a target action date of March 19, 2021.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is set to host a virtual investor and analyst event on December 8, 2020, from 1:00 - 2:30 p.m. ET. The event will focus on the Company’s cancer therapy pipeline and key data from the American Society of Hematology (ASH) 2020 Annual Meeting. Karyopharm's management, alongside experts in multiple myeloma and leukemia, will present and engage in a Q&A session. The event will be accessible via phone and an audio webcast will be available on their investor website after the event.
Karyopharm Therapeutics (Nasdaq: KPTI) announced the appointment of Chen Schor as a Board Director and Stephen Mitchener as Chief Business Officer. Schor, previously CEO of Adicet Bio, brings extensive leadership in biotech, aiming to enhance Karyopharm's growth in oncology. Mitchener, formerly with Axcella Healthcare, will leverage his experience in strategic finance and partnerships to expand Karyopharm's commercial reach. In connection with Mitchener's hiring, stock options were granted under Nasdaq rules, with a total of 159,000 shares allocated to newly hired employees.
Karyopharm Therapeutics (Nasdaq: KPTI) announced that its Phase 3 SIENDO study of XPOVIO (selinexor) for advanced endometrial cancer passed a planned interim futility analysis. The Data and Safety Monitoring Board recommended continuing the study without protocol modifications. The study features 248 patients randomized to receive either XPOVIO or placebo, aiming to demonstrate a hazard ratio of 0.6 for progression-free survival. Top-line data is expected in the second half of 2021. XPOVIO has previously received FDA approvals for multiple myeloma and diffuse large B-cell lymphoma.
Karyopharm Therapeutics (KPTI) announced positive results from the Phase 3 SEAL study for XPOVIO® (selinexor) in treating advanced unresectable dedifferentiated liposarcoma at CTOS 2020. The study demonstrated a statistically significant increase in median progression-free survival (PFS) for patients treated with XPOVIO (2.83 months) compared to placebo (2.07 months, HR=0.70; p=0.023). XPOVIO also achieved a 30% reduced risk of disease progression or death. A New Drug Application to the FDA is anticipated in Q1 2021, marking XPOVIO as a potential first oral therapy for this cancer type.
Karyopharm Therapeutics (KPTI) announced results from the Phase 3 BOSTON study, published in The Lancet, which evaluated XPOVIO in combination with Velcade® and low-dose dexamethasone for relapsed or refractory multiple myeloma. The once-weekly regimen (SVd) showed a 30% reduction in disease progression or death risk compared to the standard regimen (Vd). Key metrics included a 47% improvement in progression-free survival and a 76.4% overall response rate. The FDA accepted a supplemental New Drug Application for XPOVIO with a PDUFA date of March 19, 2021.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a leader in cancer therapies, will have CEO Michael Kauffman participate in a fireside chat at the Jefferies 2020 Virtual London Healthcare Conference on November 17, 2020, at 1:45 p.m. ET. Investors can access the live webcast on the company's investor site, with a replay available for 90 days after the event. Karyopharm specializes in novel drugs targeting nuclear export, notably XPOVIO® (selinexor), which received FDA approval for multiple myeloma and lymphoma. For more details, visit www.karyopharm.com.
Karyopharm Therapeutics (Nasdaq: KPTI) announced the selection of twenty-one abstracts for virtual presentation at the ASH 2020 Annual Meeting, scheduled for December 5-8, 2020. Noteworthy presentations will include updated clinical data for XPOVIO (selinexor) in combination therapies for multiple myeloma and lymphoma. Key studies from the STOMP and BOSTON trials will be highlighted, showcasing encouraging response rates and safety profiles. An investor event will be held to discuss the clinical program and ASH data.