Karyopharm Therapeutics Inc Stock Price, News & Analysis

Karyopharm Therapeutics (Nasdaq: KPTI) has announced the validation of its Type II Variation Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for NEXPOVIO® (selinexor). This application aims to expand the use of NEXPOVIO in combination with Velcade® and low-dose dexamethasone for treating adult patients with multiple myeloma who have undergone at least one prior therapy. The decision is based on encouraging results from the Phase 3 BOSTON study. The EMA's review is expected to conclude in Q4 2021, signifying a vital step in enhancing treatment options for multiple myeloma in Europe.

Karyopharm Therapeutics (Nasdaq: KPTI) announced the publication of health-related quality of life (HRQoL) data from the Phase 3 SEAL study, evaluating selinexor in advanced unresectable dedifferentiated liposarcoma (DDLPS). The study showed a statistically significant improvement in progression-free survival (PFS) and notable reductions in pain for patients treated with selinexor compared to placebo. With 285 patients involved, the results underscore selinexor's potential to provide meaningful clinical benefits, despite being unapproved for DDLPS. Adverse effects included manageable cytopenias and gastrointestinal issues.

Karyopharm Therapeutics (Nasdaq: KPTI) announced the granting of stock options for 150,600 shares to 15 new employees, effective March 31, 2021. The options have an exercise price of $10.52, aligning with the closing price on the grant date. These options will vest over four years, with an initial 25% vesting after one year, followed by monthly vesting. Additionally, the options may become fully exercisable upon termination for 'good reason' or without 'cause' after a 'change in control' event. This move is expected to attract talent as the company advances its cancer therapies.

Karyopharm Therapeutics (Nasdaq: KPTI) announced that the European Commission has granted conditional marketing authorization for NEXPOVIO (selinexor) in combination with dexamethasone for treating adult patients with heavily pretreated multiple myeloma. This breakthrough therapy targets patients who have undergone at least four prior treatments and are refractory to multiple other therapies. The authorization is based on positive results from the Phase 2b STORM study, which showed a 26% overall response rate. The drug is the first nuclear export inhibitor approved in Europe and is set for initial availability through a Named Patient Program.

Karyopharm Therapeutics (Nasdaq: KPTI) announced the granting of stock options to 11 new employees. An aggregate of 93,600 shares is available for purchase at an exercise price of $13.82 per share, corresponding to the closing price on February 26, 2021. These options vest over four years, with 25% vesting after one year and subsequent monthly vesting. The options will fully vest upon certain termination scenarios within a year of a 'change in control event.'

Karyopharm Therapeutics (Nasdaq: KPTI), a company focused on innovative cancer therapies, will have CEO Michael Kauffman participate in two virtual investor conferences. The SVB Leerink 10th Annual Global Healthcare Conference is scheduled for February 24, 2021, at 1:00 PM ET, while the Barclays Global Healthcare Conference will take place on March 9, 2021, at 9:10 AM ET. Live webcasts will be available on Karyopharm's website, with replays accessible for 30 days post-event.

Karyopharm Therapeutics (KPTI) reported fourth quarter 2020 net product revenue of $20.2 million, a 5% decline from Q3 2020, attributed to COVID-19 impacts and increased competition. The company achieved FDA approval for XPOVIO in additional oncology indications, expanding its market potential. Total revenue for 2020 was $76.2 million, a significant increase from $30.5 million in 2019. However, the net loss for Q4 was $43.4 million, an improvement from Q4 2019. Karyopharm maintains a strong cash position of $276.7 million as it looks ahead to 2021.

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) will announce its fourth quarter and full year 2020 financial results on February 11, 2021. A conference call will be hosted by the management team at 8:30 a.m. ET to discuss these results and provide company updates. Karyopharm specializes in innovative cancer therapies, including its lead drug, XPOVIO® (selinexor), which has multiple U.S. approvals for various hematologic malignancies. A Marketing Authorization Application for selinexor is also under review by the European Medicines Agency.

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.