Karyopharm Therapeutics Inc Stock Price, News & Analysis

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.

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.