Karyopharm Therapeutics Inc Stock Price, News & Analysis

Karyopharm Therapeutics (KPTI) announced that its investigational drug, eltanexor, received FDA Fast Track designation and European Orphan Medicinal Product designation for the treatment of myelodysplastic syndromes (MDS). This signifies a crucial need for new therapies for patients with relapsed or refractory MDS, which currently lacks approved treatments. About 15,000 and 14,000 individuals in the U.S. and EU, respectively, are projected to be diagnosed with high-risk MDS in 2022. The fast track process aims to expedite drug development, while orphan designation allows for various incentives.

Karyopharm Therapeutics (Nasdaq: KPTI) announced the approval of stock options for 32,600 shares and 22,400 restricted stock units (RSUs) to 11 new employees, effective June 30, 2022. These grants serve as inducements for their employment, in compliance with Nasdaq Listing Rule 5635(c)(4). The stock options, priced at $4.51, will vest over four years, with 25% vesting after one year and the remainder monthly. RSUs will vest similarly over four years. Each award can be exercised fully if employment ends for 'good reason' or is terminated without 'cause' within the first year after a change in control.

Karyopharm Therapeutics (Nasdaq: KPTI) announced the grant of stock options for 136,700 shares and 90,700 restricted stock units (RSUs) to 18 newly hired employees as of May 31, 2022. This is part of the Company's 2022 Inducement Stock Incentive Plan, aligning with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $6.28 per share and will vest over four years. The RSUs will also vest over four years, with 25% vesting annually. These awards incentivize talent acquisition in the competitive pharmaceutical industry.

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) will participate in a fireside chat at the Jefferies Healthcare Conference on June 9, 2022, at 9:30 a.m. ET, in New York, NY. The event will feature the senior management team and will be accessible via live webcast on the company's Investor website, with replays available for 90 days after the conference. Karyopharm specializes in innovative cancer therapies, including its XPOVIO® (selinexor), which targets various high unmet cancer needs.

Karyopharm Therapeutics (Nasdaq: KPTI) announced positive results from a Phase 1/2 study of selinexor combined with ruxolitinib for treatment-naïve myelofibrosis, showing a 75% spleen volume reduction in evaluable patients at week 12. The FDA granted Orphan Drug Designation for selinexor in treating myelofibrosis. Additionally, exploratory analyses from the SIENDO trial indicated that p53 wild-type patients with endometrial cancer had improved progression-free survival with selinexor. Findings will be presented at ASCO 2022 in Chicago from June 3-7.

Karyopharm Therapeutics (KPTI) announces the initiation of the Phase 3 study EMN29/XPORT-MM-031, focusing on an all-oral regimen of selinexor combined with pomalidomide and low-dose dexamethasone. This global study, which has begun dosing its first patient, aims to evaluate the treatment's efficacy and safety in patients with relapsed or refractory multiple myeloma. The primary endpoint is progression-free survival, with around 280 patients expected to be recruited. Top-line results are anticipated in 2024.

Karyopharm Therapeutics (Nasdaq: KPTI) announced a positive opinion from the European Medicines Agency's CHMP recommending the approval of NEXPOVIO® (selinexor) for adults with multiple myeloma who have undergone 1-3 prior therapies. This recommendation is a crucial step towards receiving marketing authorization from the European Commission, expected in about 60 days. Supported by the Phase 3 BOSTON study, the treatment demonstrated significant improvements in progression-free survival and overall response rate. The collaboration with Menarini will aid in commercialization across Europe.

Karyopharm Therapeutics (Nasdaq: KPTI) and Menarini Group announced a positive recommendation from the EMA’s CHMP for NEXPOVIO® (selinexor) in combination with bortezomib and low-dose dexamethasone for treating adult multiple myeloma patients with one to three prior therapies. This recommendation precedes a final decision from the European Commission, expected in about 60 days. The application is supported by Phase 3 BOSTON study data, showing significant improvements in progression-free survival and overall response rates compared to standard therapy.

Karyopharm Therapeutics (NASDAQ: KPTI) announced that initial data from a Phase 1 study of selinexor combined with ruxolitinib in treatment-naïve myelofibrosis patients will be presented at the EHA 2022 Congress in Vienna and the ASCO Annual Meeting. The need for innovative treatments for myelofibrosis is emphasized as current therapies are limited to JAK inhibitors. The presentation highlights the potential of selinexor in improving patient outcomes, including spleen size reduction and quality of life. Further data updates will follow at both conferences.