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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 Promedico Ltd. has received approval from the Israeli Ministry of Health for XPOVIO® (selinexor) to treat multiple myeloma and diffuse large B-cell lymphoma (DLBCL). The approved use includes XPOVIO combined with dexamethasone for adult patients with relapsed refractory multiple myeloma who have undergone at least three therapies and for those with relapsed or refractory DLBCL post two systemic therapies. Karyopharm anticipates further registration in Israel by Q2 2021 and awaits a European Commission decision on NEXPOVIO® by April 2021.
Karyopharm Therapeutics (Nasdaq: KPTI) announced on February 1, 2021, that its Compensation Committee granted stock options for 165,500 shares to 31 new employees as an inducement for joining the company. The stock options have an exercise price of $15.23, equal to the closing stock price on January 29, 2021, and will vest over four years. They will be immediately exercisable under certain conditions related to employment termination. KPTI develops novel cancer therapies, with its lead drug, XPOVIO®, approved in various hematologic malignancy indications.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced that the European Medicines Agency's CHMP has issued a positive opinion recommending conditional approval for NEXPOVIO® (selinexor) in combination with dexamethasone for treating multiple myeloma in patients with extensive prior therapy. This recommendation is a critical step toward a final decision by the European Commission, expected by April 2021. The MAA is supported by the Phase 2b STORM study, showing a 26% overall response rate in heavily pretreated patients. Karyopharm plans to expand its regulatory filing based on additional study data.
Karyopharm Therapeutics (Nasdaq: KPTI) reported preliminary unaudited revenue estimates for Q4 and full year 2020, expecting total revenues of $35-$36 million for the fourth quarter and $108-$109 million for the year. Net product sales for XPOVIO are estimated between $20-$20.5 million for Q4 and $76-$76.5 million for the year. A decline in sales was noted, attributed to COVID-19 impacts and increased competition. The company entered a distribution agreement for XPOVIO in Canada, generating $15 million in license revenue. The cash position increased to $277 million by year-end 2020.
Karyopharm Therapeutics (Nasdaq: KPTI) announced stock options granted to 12 new employees, totaling 50,500 shares. The options, with an exercise price of $15.48 per share, were issued as inducements for joining the company, in line with Nasdaq Listing Rule 5635(c)(4). Each option vests over four years, with 25% vesting after the first year. Additionally, options will be fully exercisable if employment is terminated under specific conditions within a year of a 'change in control.' This move supports Karyopharm's growth in developing innovative cancer therapies.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced that CEO Michael Kauffman will present at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 4:30 p.m. ET, followed by a Q&A session at 4:50 p.m. ET. The presentation will be available via live webcast, and a replay will be archived for 30 days. Karyopharm is focused on developing innovative cancer therapies, with its lead compound, XPOVIO® (selinexor), already approved for multiple hematologic malignancies in the U.S. and under review in Europe.
On January 3, 2021, Antengene Corporation announced the submission of a New Drug Application (NDA) for ATG-010 (selinexor, XPOVIO®) to the South Korean Ministry of Food and Drug Safety. The NDA, which includes Orphan Drug Designation, aims to treat relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma. The application is supported by positive results from pivotal studies STORM and SADAL. Antengene also filed NDAs in Singapore and Australia and highlights the urgency for innovative therapies in hematological malignancies.
Antengene Corporation Limited announced that Karyopharm Therapeutics Inc. has received FDA approval for the supplemental NDA of XPOVIO® (selinexor), a first-in-class oral SINE inhibitor for treating adult patients with multiple myeloma after at least one prior therapy. This approval comes three months ahead of schedule, based on the successful Phase 3 BOSTON study demonstrating improved progression-free survival. XPOVIO® is now the only FDA-approved drug for both multiple myeloma and diffuse large B-cell lymphoma. Antengene aims to launch this treatment in Asia-Pacific markets soon.
Karyopharm Therapeutics (Nasdaq: KPTI) announced FDA approval of XPOVIO® (selinexor) in combination with bortezomib and dexamethasone for adult patients with multiple myeloma after at least one prior therapy. This expanded label broadens XPOVIO's market potential, supported by positive Phase 3 BOSTON study results showing a 47% improvement in progression-free survival versus standard therapy. The company will leverage its commercial infrastructure for immediate launch while collaborating with the EMA on XPOVIO’s marketing application in Europe.
Karyopharm Therapeutics (Nasdaq: KPTI) has appointed Michael Mano as Senior Vice President and General Counsel, bringing over 15 years of legal experience from Biogen. His expertise in intellectual property, corporate governance, and financing is expected to support Karyopharm's growth strategies, particularly for its drug XPOVIO. As part of his inducement to join, Mano received a stock option for 100,000 shares at an exercise price of $15.57, vesting over four years. Karyopharm aims to expand XPOVIO’s market presence amid ongoing clinical trials for various cancer indications.