Karyopharm Therapeutics Inc. - KPTI STOCK NEWS

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.

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.