KPTI 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• Our primary focus is on marketing XPOVIO in its currently approved indications as well as developing and seeking regulatory approval of selinexor as an oral agent targeting multiple high unmet need cancer indications, including our lead clinical programs in myelofibrosis and endometrial cancer and o…

• On March 24, 2026, we announced topline data results from our Phase 3 clinical trial to evaluate the efficacy and safety of once-weekly selinexor in combination with ruxolitinib versus placebo plus ruxolitinib in JAK2 inhibitor (“JAKi”)-naive myelofibrosis patients (the “SENTRY Trial”) in which pati…

• We continue to enroll JAKi-naïve myelofibrosis patients in the Phase 2 clinical trial to evaluate the safety and efficacy of selinexor as a monotherapy in patients with JAKi-naïve myelofibrosis with moderate thrombocytopenia (the “SENTRY-2 Trial”). We completed enrollment of the 60 mg cohort of the …

• We have completed enrollment of our global, Phase 3, randomized, double-blind trial evaluating selinexor as a maintenance-only therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (the “XPORT-EC-042 Trial”). Approximately 220 patients enrolled i…

• Patients enrolled in a randomized global Phase 3 trial sponsored by the European Myeloma Network evaluating an all-oral combination of selinexor 40 mg in combination with pomalidomide and dexamethasone versus elotuzumab, pomalidomide, and dexamethasone in patients with previously treated multiple my…

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved under accelerated approval based on response …

• We completed enrollment in our ongoing Phase 3 SENTRY trial evaluating selinexor in combination with once or twice-daily ruxolitinib versus placebo plus ruxolitinib in JAKi-naive myelofibrosis patients in September 2025. We expect to report top-line data from the SENTRY trial in March 2026. We conti…

• We are continuing to enroll patients in the Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer. We expect to report top-line data from this event-driven trial…

• Our primary focus is on marketing XPOVIO in its currently approved indications as well as developing and seeking the regulatory approval of selinexor as an oral agent targeting multiple high unmet need cancer indications, including our lead clinical programs in myelofibrosis and our other late-stage…

• As of September 30, 2025, we had an accumulated deficit of $1.7 billion. We had net losses of $93.8 million and $45.6 million for the nine months ended September 30, 2025 and 2024, respectively. Based on our current business plan and current capital resources, given the uncertainty regarding the ava…

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• initiating and successfully completing clinical trials required to file for, obtain and maintain marketing approval for our product candidates, including reporting a positive benefit-risk profile from our ongoing Phase 3 clinical trial in endometrial cancer, with topline data anticipated in mid-2026…

• placement of selinexor in the treatment recommendations adopted by the National Comprehensive Cancer Network and similar guidelines;

• evaluate strategic opportunities, such as the acquisition or in-license of other products, product candidates, technologies or companies.

• Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations, and any such efforts could divert management’s attention away from their day-to-day activities. However, adequate addi…

• In addition, changes in government policies, priorities and administration could create increased uncertainty and volatility that adversely affect our business, our ability to raise capital, and our ability to enter into strategic alternatives. For example, evolving healthcare, pricing and reimburse…

相对上期删除的文字 · 来源:10-Q · 2025-11-03

• investment. If there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all.

• initiating and successfully completing clinical trials required to file for, obtain and maintain marketing approval for our product candidates;

• acquire or in-license other products, product candidates or technologies.

• Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations. Any future fundraising efforts could divert management’s attention away from their day-to-day activities. Further, ade…

• We are continuing to evaluate strategic alternatives, which may include a potential merger or sale of the Company; in or out of court restructurings; repurchases, redemptions, exchanges or other refinancings of the Company’s existing debt; potential financing transactions; among other potential alte…