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Karyopharm files sNDA seeking FDA approval for myelofibrosis combo

Mon, 31 Aug 2026 07:32:30 -0400

Karyopharm Therapeutics (Nasdaq: KPTI) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis, according to a company statement.

The company has also requested Priority Review of the application, which, if granted, could result in a six-month review process. Karyopharm expects to receive notice of the FDA's filing acceptance decision in the fourth quarter of 2026, following the agency's standard 60-day filing review period.

The sNDA is based in part on data from the Phase 3 SENTRY trial. Karyopharm stated it believes the

Karyopharm files sNDA seeking FDA approval for myelofibrosis combo

Mon, 31 Aug 2026 07:32:30 -0400

The sNDA is based in part on data from the Phase 3 SENTRY trial. Karyopharm stated it believes the

Form SCHEDULE 13G/A Karyopharm Therapeutics Filed by: RA CAPITAL MANAGEMENT, L.P.

Fri, 14 Aug 2026 16:49:00 -0400

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Form SCHEDULE 13G/A Karyopharm Therapeutics Filed by: RA CAPITAL MANAGEMENT, L.P.

Fri, 14 Aug 2026 16:49:00 -0400

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Form SCHEDULE 13G/A Karyopharm Therapeutics Filed by: Commodore Capital LP

Fri, 14 Aug 2026 16:20:00 -0400

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Form SCHEDULE 13G/A Karyopharm Therapeutics Filed by: Commodore Capital LP

Fri, 14 Aug 2026 16:20:00 -0400

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Form 10-Q Karyopharm Therapeutics For: Jun 30

Thu, 13 Aug 2026 07:41:00 -0400

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Form 10-Q Karyopharm Therapeutics For: Jun 30

Thu, 13 Aug 2026 07:41:00 -0400

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Form 8-K Karyopharm Therapeutics For: Aug 13

Thu, 13 Aug 2026 07:38:00 -0400

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Form 8-K Karyopharm Therapeutics For: Aug 13

Thu, 13 Aug 2026 07:38:00 -0400

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Karyopharm Therapeutics (KPTI) Misses Q2 EPS by $1.01, Beats on Revenue; Offers FY26 Revenue Guidance

Thu, 13 Aug 2026 07:34:15 -0400

Karyopharm Therapeutics (NASDAQ: KPTI) reported Q2 EPS of ($2.32), $1.01 worse than the analyst estimate of ($1.31). Revenue for the quarter came in at $33.4 million versus the consensus estimate of $33.12 million.

GUIDANCE:

Karyopharm Therapeutics sees FY2026 revenue of $130-150 million, versus the consensus of $133.7 million.

For earnings history and earnings-related data on Karyopharm Therapeutics (KPTI) click here.

Karyopharm Therapeutics (KPTI) Misses Q2 EPS by $1.01, Beats on Revenue; Offers FY26 Revenue Guidance

Thu, 13 Aug 2026 07:34:15 -0400

GUIDANCE:

Karyopharm Therapeutics sees FY2026 revenue of $130-150 million, versus the consensus of $133.7 million.

For earnings history and earnings-related data on Karyopharm Therapeutics (KPTI) click here.

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –

– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –

– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –

– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

Thu, 13 Aug 2026 07:30:00 -0400

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –
– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –
– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130