Karyopharm Therapeutics Inc. - KPTI STOCK NEWS

Karyopharm Therapeutics (KPTI) provided an update on its discussions with the FDA regarding its supplemental New Drug Application (sNDA) for selinexor, intended for advanced endometrial cancer. The FDA indicated that existing SIENDO study results might not justify an sNDA approval. Differing views on the study's clinical significance led to plans for a new randomized clinical trial focusing on p53 wild-type patients, with top-line data expected in H1 2024. The SIENDO study results will be presented at upcoming oncology conferences in March 2022.

Karyopharm Therapeutics (Nasdaq: KPTI) announced on February 28, 2022, the approval of stock options for 168,500 shares and 112,200 restricted stock units (RSUs) to nine new employees. These awards are part of the 2022 Inducement Stock Incentive Plan and serve as an employment inducement per Nasdaq Listing Rule 5635(c)(4). Each option has an exercise price of $10.33, vesting over four years, with specific conditions for immediate exercise upon a change in control or termination for good reason.

Karyopharm Therapeutics (Nasdaq: KPTI) announced key changes in its clinical leadership team on February 22, 2022. Patricia Judson, M.D., joins as Senior VP of Medical Strategy, and Stuart Poulton as Senior VP of Strategy and Portfolio Management. Jatin Shah, M.D., has stepped down as Chief Medical Officer but will remain in an advisory role. Richard Paulson, CEO, highlighted that the new leaders bring extensive oncology and pharmaceutical experience, which will aid the company in advancing its drug pipeline addressing significant unmet medical needs.

Karyopharm Therapeutics (Nasdaq: KPTI), a leader in cancer therapies, announced that CEO Richard Paulson will participate in a virtual fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 1:40 p.m. ET. A live webcast will be available in the Investor section of their website, with replays accessible for 90 days. Karyopharm specializes in oral Selective Inhibitor of Nuclear Export (SINE) technology, including its approved drug XPOVIO®. The company's pipeline targets multiple high unmet need cancer indications.

Karyopharm Therapeutics (Nasdaq: KPTI) reported strong financial results for Q4 2021, with net product revenue of $29.8 million, a 47% increase year-over-year. Total revenue for 2021 reached $209.8 million, up from $108.1 million in 2020. They achieved significant milestones, including a commercialization partnership with Menarini and positive data from the SIENDO study on selinexor. However, the company reported a net loss of $124.1 million for 2021. For 2022, Karyopharm expects XPOVIO revenue between $135 million and $145 million.

Karyopharm Therapeutics (Nasdaq: KPTI) reported positive results from its Phase 3 SIENDO study on selinexor for patients with advanced or recurrent endometrial cancer. The study involved 263 patients and achieved a median progression-free survival (PFS) of 5.7 months with selinexor, compared to 3.8 months for placebo, marking a 50% improvement. The drug showed a 30% reduction in disease progression risk. Particularly, patients with wild-type p53 saw a median PFS of 13.7 months. Karyopharm plans to submit a supplemental New Drug Application to the FDA in H1 2022.

Karyopharm Therapeutics (KPTI) will report its fourth quarter and full year 2021 financial results on February 8, 2022. Management will hold a conference call at 8:30 a.m. ET on the same day to discuss the results and updates. Karyopharm is known for its novel cancer therapies, including the first-in-class XPO1 inhibitor, XPOVIO®, and has a focused pipeline targeting high unmet needs in cancer treatments. Interested parties can access the call via phone or a live audio webcast on the company's website.

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) announced the grant of stock options for 124,500 shares to 15 newly-hired employees, effective January 31, 2022. The exercise price is set at $8.90 per share, reflecting the stock's closing price on the grant date. Options will vest over four years, with 25% vesting after one year and the remainder monthly. The options are also subject to immediate exercise if the employee's role is terminated without cause within a year following a 'change in control.' This move aligns with Nasdaq rules for inducements to new hires.

Karyopharm Therapeutics (Nasdaq: KPTI) announced the FDA granted orphan drug designation for eltanexor, a novel oral SINE compound, aimed at treating myelodysplastic syndromes (MDS). This designation supports the development of therapies for conditions affecting fewer than 200,000 patients annually, offering incentives such as potential market exclusivity. Eltanexor has shown a 53% overall response rate in clinical trials for HMA-refractory MDS, significantly improving survival rates compared to standard treatments. Karyopharm remains focused on advancing its clinical trials to provide new options for patients.