Karyopharm Therapeutics Inc. - KPTI STOCK NEWS

Karyopharm Therapeutics (Nasdaq: KPTI) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for XPOVIO (selinexor) as a treatment for multiple myeloma after at least one prior line of therapy. The FDA decision is expected by the end of Q1 2021. XPOVIO, already approved for penta-refractory multiple myeloma and relapsed diffuse large B-cell lymphoma, aims to broaden its patient base. Karyopharm intends to submit a Marketing Authorization Application to the European Medicines Agency for this indication.

Karyopharm Therapeutics (Nasdaq: KPTI) announced a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to advance XPOVIO (selinexor), a first-in-class oral cancer treatment. The partnership aims to explore XPOVIO's efficacy across various cancer types, supported by promising anti-tumor activity from previous studies. Currently approved for relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma, XPOVIO has a supplemental FDA application for expanded treatment indications. Karyopharm is dedicated to addressing significant unmet medical needs in oncology.

Karyopharm Therapeutics (Nasdaq: KPTI) reported preliminary unaudited net product sales of approximately $18.5 million for its oral cancer treatment XPOVIO in Q2 2020, marking a 15% increase from Q1 2020, the highest quarterly sales since its launch in July 2019. Despite challenges from the COVID-19 pandemic, demand from healthcare providers remains strong. The FDA recently granted accelerated approval for XPOVIO in treating relapsed or refractory diffuse large B-cell lymphoma, following promising Phase 3 study results for multiple myeloma. Full financial results will be announced in August.

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced the grant of stock options to purchase 41,700 shares of its common stock to eight new employees as part of their inducement for joining the company. The options, priced at $18.94 per share, were approved by the Compensation Committee on June 30, 2020, in compliance with Nasdaq Listing Rule 5635(c)(4). These options vest over four years with specific conditions regarding termination tied to a change in control event. Karyopharm is focused on developing innovative treatments for cancer and other major diseases.

Karyopharm Therapeutics (KPTI) announced positive results from the Phase 2b SADAL study, assessing XPOVIO (selinexor) for relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL). The study reported an overall response rate of 28%, with a complete response rate of 12%. Notably, the median duration of response was 9.3 months. FDA approved XPOVIO for this indication on June 22, 2020, under the Accelerated Approval Program. A European submission is planned for 2021, further extending its market potential.

Karyopharm Therapeutics announced FDA approval for XPOVIO® (selinexor), now the only single-agent oral therapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This first-in-class drug also holds the distinction of being the only FDA-approved treatment for both DLBCL and multiple myeloma. The approval comes under the FDA’s Accelerated Approval Program, based on a 29% overall response rate in clinical studies. XPOVIO will be available immediately in the U.S., with plans for a European submission in 2021. Continued approval depends on further clinical trials to confirm its benefits.

Karyopharm Therapeutics (KPTI) announced the presentation of eight posters on XPOVIO (selinexor) and eltanexor at the EHA 2020 Virtual Annual Meeting from June 11-21, 2020. Key findings include a 9-month median overall survival in relapsed/refractory DLBCL patients treated with selinexor, demonstrating significant efficacy over historical controls. Additional analyses show durable responses across treatment histories. Eltanexor data highlights potential effectiveness against NPM1-mutated AML and predictive molecular markers for multiple myeloma responses. The FDA's decision on KPTI's supplemental application is expected later this month.

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced the grant of stock options for 25,800 shares to seven new employees, effective May 29, 2020. This grant, in accordance with Nasdaq rules, serves as an employment inducement. Each option has an exercise price of $18.49 and will vest over four years. Notably, options can be exercised in full if employment ends without cause within a year following a change in control. Karyopharm focuses on innovative drugs targeting nuclear export for cancer treatments, with ongoing regulatory processes for its lead drug, XPOVIO.

Karyopharm Therapeutics (KPTI) announced significant results from the Phase 3 BOSTON study, which evaluated the once-weekly regimen of XPOVIO (selinexor), Velcade (bortezomib), and dexamethasone (SVd) in multiple myeloma patients. The study revealed a 47% increase in median progression-free survival (PFS) compared to the standard treatment. Additionally, SVd demonstrated superior overall response rates and lower rates of peripheral neuropathy. A supplemental New Drug Application has been submitted to the FDA for XPOVIO's approval as a new treatment option.