Karyopharm Therapeutics Inc - KPTI STOCK NEWS

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.

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.