Karyopharm Therapeutics

Karyopharm Therapeutics, Inc. is a commercial-stage pharmaceutical company, which engages in the discovery, development, and commercialization of drugs directed against nuclear export for the treatment of cancer and other diseases. Its Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s compound, XPOVIO (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses, and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. The company was founded by Joseph Araujo, Ronald A. DePinho, Pamela A Silver, Giulio Draetta, Michael G. Kauffman, and Sharon Shacham on December 22, 2008 and is headquartered in Newton, MA.

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Karyopharm reports robust revenue growth and strategic clinical advancements

Karyopharm Therapeutics demonstrated strong performance in revenue growth and clinical pipeline advancements, positioning them for continued success in 2023.
Strategic strengths in product portfolio, leadership, and innovation align well with opportunities in accelerating growth and exploring novel treatment approaches.
Challenges in differentiation, data updates, and dose optimization require focused strategies to overcome obstacles and drive sustainable growth.
Overall, Karyopharm's focus on patient outcomes, strategic expansion, and upcoming milestones indicate a positive trajectory for the company.

Karyopharm Therapeutics navigates revenue challenges while advancing pipeline innovations

Karyopharm Therapeutics faced revenue challenges due to PAP usage and discounts but showcased strong demand for XPOVIO and promising pipeline progress.
The company's financial stability was supported by expense reductions and total revenue of $38.7 million for Q1 2023.
Opportunities lie in commercial expansions, Phase III data advancements, and strategic product development efforts, positioning Karyopharm for future growth and innovation.

Karyopharm Therapeutics excels in Q2, eyes $2B peak revenues

Karyopharm Therapeutics showcased strong financial performance, strategic workforce reductions, and progress in pivotal Phase III trials during the Q2 earnings call. The company's focus on advancing novel SINE compounds and maintaining financial strength positions them well for future growth and value creation.

Karyopharm Therapeutics reports robust Q3 earnings and highlights growth prospects

Karyopharm Therapeutics showcased strong financial performance with revenue of $36 million and emphasized growth potential.
Promising Phase III trial data for myelofibrosis and endometrial cancer positions selinexor as a treatment paradigm changer.
Challenges include PAP impact from foundation closures, but opportunities lie in novel drug combinations and growth strategies.

Karyopharm meets revenue targets, eyes transformative outcomes in trials

Karyopharm Therapeutics delivered on revenue targets, showcasing strong performance and promising trial results in key indications.
While facing challenges in academic settings and financial obligations, the company's strategic strengths and growth opportunities position it well for the future.
With a focus on advancing Phase III trials, leveraging IP advantages, and exploring new treatment avenues, Karyopharm aims for continued innovation and market expansion.
Overall, Karyopharm's Q4 2023 Earnings Call reflects a balanced outlook with a solid foundation for growth and value creation in the biopharmaceutical sector.

Karyopharm Therapeutics reports strong Q1 performance and strategic refinancing

Karyopharm Therapeutics' Q1 2024 earnings call highlighted robust performance, strategic refinancing, and promising late-stage pipeline developments. While facing challenges in financial clarity and trial progress, the company is well-positioned to capitalize on growth opportunities through biomarker-driven patient selection and combination therapies.

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Karyopharm Therapeutics, Inc. is a commercial-stage pharmaceutical company, which engages in the discovery, development, and commercialization of drugs directed against nuclear export for the treatment of cancer and other diseases. Its Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s compound, XPOVIO (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses, and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. The company was founded by Joseph Araujo, Ronald A. DePinho, Pamela A, Silver, Giulio Draetta, Michael G. Kauffman, and Sharon Shacham on December 22, 2008 and is headquartered in Newton, MA.

Long-Term Selinexor Data in Myelofibrosis will be Presented as Part of Oral Presentation NEWTON, Mass. , Nov. 2, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that several abstracts that include selinexor data in myelofibrosis (MF) have been selected for presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12, 2023, in San Diego, CA.

Karyopharm Announces Presentations at the 65th American Society of Hematology Annual Meeting and Exposition (ASH)

– Achieved Third Quarter 2023 Total Revenue of $36.0 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $30.2 Million – –  Maintains Full Year 2023 Total Revenue Guidance of $145 Million to $160 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $110 Million to $125 Million – –  Strong SVR and TSS Durability Observed from Phase 1 Study of Selinexor 60mg and Ruxolitinib in JAK Inhibitor (JAKi)-Naïve Myelofibrosis Patients, with No SVR or TSS Progressions Observed 1  – – Announced Clinical Trial Collaboration with Bristol Myers Squibb to Evaluate Novel CELMoD™ Agent CC- 92480, Mezigdomide in Combination with Selinexor in Patients with R/R Multiple Myeloma Progressing After T-cell Immunotherapies – – Conference Call Scheduled for Today at 8:00 a.m. ET – NEWTON, Mass.

Karyopharm Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Bristol-Myers

—  Phase 1b/2 Trial Will Investigate Mezigdomide in Combination with  Selinexor  in Patients with Relapsed/Refractory Multiple Myeloma Progressing after T-cell Immunotherapies – — Expected to be Initiated 1H 2024 – NEWTON, Mass. , Oct. 30, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has entered into a clinical trial collaboration and supply agreement with Bristol-Myers Squibb (NYSE: BMY) to evaluate the company's proprietary investigational cereblon E3 ligase modulator (CELMoD™) agent mezigdomide in combination with Karyopharm's selinexor, an approved first-in-class inhibitor of Exportin 1 (XPO1), plus dexamethasone in patients with relapsed/refractory multiple myeloma.

Karyopharm Announces Clinical Trial Collaboration with Bristol Myers Squibb to Evaluate Novel CELMoD™ Agent CC- 92480 Mezigdomide in Combination with Selinexor in Patients with Relapsed/Refractory Multiple Myeloma

-- Conference Call Scheduled for Thursday, November 2, 2023, at 8:00 a.m. ET -- NEWTON, Mass.

Karyopharm to Report Third Quarter 2023 Financial Results on November 2, 2023

NEWTON, Mass. , Sept. 26, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that several abstracts detailing new selinexor data have been selected to be presented at the 2023 International Myeloma Society (IMS) Annual Meeting, being held September 27-30 in Athens, Greece.

Karyopharm to Present Selinexor Data at the 2023 International Myeloma Society Annual Meeting and European Society of Gynaecological Oncology 2023 Annual Meetings

NEWTON, Mass. , Sept. 1, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the appointment of Zhen Su, MD, MBA, to its Board of Directors, effective August 31, 2023.

Karyopharm Appoints Zhen Su, MD, MBA to its Board of Directors

-      Antengene and Hansoh Pharma to enter into collaboration agreement involving commercialization of XPOVIO® in the mainland of China, broadening coverage and improving access of the drug to patients in the mainland of China -      Antengene to receive up to RMB200 million in upfront payments, and up to RMB535 million in milestone payments from Hansoh Pharma -      XPOVIO® is approved in the mainland of China for relapsed/refractory multiple myeloma. Antengene plans to submit supplemental new drug application (sNDA) for XPOVIO® as a monotherapy for the treatment of adult patients with relapsed /refractory diffuse large B-cell lymphoma in Q3 2023, and in combination for the treatment of adult patients with multiple myeloma who have received at least one prior therapy  in H1 2024 -      Recent clinical data presentation showcased broad indication expansion potential in myelofibrosis and endometrial cancer SHANGHAI and HONG KONG , Aug. 10, 2023 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, and Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma" SEHK: 3692.HK), a leading innovation-driven pharmaceutical company with a focus on the treatment of major diseases including oncology, infectious diseases, CNS disorders, metabolic diseases, and autoimmune diseases, announced today the entrance into a collaboration agreement between Antengene and Hansoh Pharma for the commercialization of XPOVIO® in the mainland of China.

Antengene Enters into Commercialization Partnership with Hansoh Pharma for First/Only-in-Class XPO1 Inhibitor XPOVIO®(selinexor) in the Mainland of China

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– Achieved Second Quarter 2023 Total Revenue of $37.6 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $28.5 Million – –  Maintains Full Year 2023 Total Revenue Guidance of $145 Million to $160 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $110 Million to $125 Million – – Announces ~20% Workforce Reduction Enhancing Financial Strength; Further Reduces Full Year 2023 Non-GAAP R&D and SG&A Expense Guidance to $240 Million to $255 Million; Cash Runway into Late 2025 – –Initiated Pivotal Phase 3 Study of XPO1 Inhibitor Selinexor and Ruxolitinib in JAK Inhibitor (JAKi) Naïve Myelofibrosis in June 2023 and Received Fast Track Designation from US FDA – – Announced Long-Term Exploratory Subgroup Analyses Presented at ASCO Plenary Providing Further Rationale for XPORT-EC-042, the Company's Ongoing Pivotal Phase 3 Study in Endometrial Cancer – – Conference Call Scheduled for Today at 8:00 a.m. ET – NEWTON, Mass.

Karyopharm Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

-- Conference Call Scheduled for Wednesday, August 2, 2023, at 8:00 a.m. ET -- NEWTON, Mass.

Karyopharm to Report Second Quarter 2023 Financial Results on August 2, 2023

Signal of PFS Improvement in SIENDO for Selinexor-Treated Patients was Observed Only in Subgroup Who are TP53 Wild-Type with a Median Progression-Free Survival of 27.4 Months  Median PFS Not Reached for Selinexor-Treated Patients Who are TP53 Wild-Type MSS (pMMR)  Updated Analysis Provides Further Rationale for XPORT-EC-042, the Ongoing Pivotal Phase 3 Study (NCT05611931) Evaluating Selinexor as Maintenance Therapy in TP53 Wild-Type Endometrial Cancer NEWTON, Mass. , July 25, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the presentation of updated exploratory subgroup analyses from the SIENDO study (NCT03555422) in patients with advanced or recurrent TP53 wild-type endometrial cancer at the virtual American Society of Clinical Oncology (ASCO) Plenary Series.

Karyopharm Announces Presentation of Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer

-  Data Provide Further Support for Company's Ongoing Phase 3 Study Evaluating Selinexor as Maintenance Therapy Following Systemic Therapy in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer - NEWTON, Mass. , July 19, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that an updated exploratory subgroup analysis from the SIENDO study (NCT03555422) in patients with advanced or recurrent TP53 wild-type endometrial cancer will be presented at the virtual American Society of Clinical Oncology (ASCO) Plenary Series.

Karyopharm Announces Updated Exploratory Subgroup Analysis from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer to be Presented at ASCO Plenary Series on July 25th

Karyopharm Therapeutics (NASDAQ: KPTI ) stock is climbing higher on Tuesday after getting fast-track designation for its myelofibrosis treatment. The Food and Drug Administration (FDA) has granted fast-track designation to the development of selinexor.

Why Is Karyopharm Therapeutics (KPTI) Stock Up 21% Today?

– Regulatory Designation Includes Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis and Post-Polycythemia Vera Myelofibrosis – – Pivotal Phase 3 Study of Selinexor and Ruxolitinib in Treatment-Naïve Myelofibrosis Initiated in June 2023 – NEWTON, Mass. , July 17, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis.

Karyopharm Receives FDA Fast Track Designation for Selinexor for the Treatment of Myelofibrosis

XPOVIO®  (selinexor) is the  first and only XPO1 inhibitor approved in Hong Kong XPOVIO®  has received regulatory approvals in 41 countries and regions  including the United States, Israel, the United Kingdom, the European Union (the 27 member countries including France and Italy), Canada, Norway, Iceland, Lichtenstein, South Korea, mainland of China, Taiwan China, Hong Kong China, Singapore, Australia and Northern Ireland. SHANGHAI and HONG KONG , July 16, 2023 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the Department of Health, the  Government of  the Hong Kong Special Administrative Region (HKSAR) has approved a New Drug Application (NDA) for XPOVIO® (selinexor), applicable in combination with dexamethasone (Xd), for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Antengene Announces XPOVIO® Regulatory Approval in Hong Kong for the Treatment of Relapsed and/or Refractory Multiple Myeloma

Karyopharm Therapeutics (KPTI) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

All You Need to Know About Karyopharm Therapeutics (KPTI) Rating Upgrade to Buy

Phase 3 Study is Supported by Previously Presented Phase 1 Study Results, Including a 78.6% SVR35 and 58.3% TSS50 in Intent to Treat Patients at Week 24 at the 60mg Dose NEWTON, Mass. , June 28, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the initiation of a pivotal Phase 3 clinical trial (XPORT-MF-034) (NCT04562389) to assess the efficacy and safety of once-weekly selinexor 60mg in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis.

Karyopharm Initiates Pivotal Phase 3 Study of XPO1 Inhibitor Selinexor and Ruxolitinib in JAK Inhibitor (JAKi) Naïve Myelofibrosis

NEWTON, Mass. , June 1, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Company's senior management team will participate at the Jefferies Healthcare Conference in a fireside chat on Thursday, June 8, 2023 at 10:00 a.m.

Karyopharm to Participate at the Jefferies Healthcare Conference

-  XPOVIO® (selinexor) is the first and only selective inhibitor of nuclear export (SINE) inhibitor approved by the Therapeutic Goods Administration (TGA) of Australia for patients with relapsed and/or refractory multiple myeloma (R/R MM) and in triple class refractory R/R MM. -  This inclusion by the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with R/R MM who have received at least one prior therapy is the second inclusion of XPOVIO® by the PBS.

Antengene Announces XPOVIO® plus Bortezomib and Dexamethasone Included for Reimbursement by the PBS in Australia for the Treatment of Relapsed and/or Refractory Multiple Myeloma

NEWTON, Mass. , May 23, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that several abstracts detailing new selinexor data have been selected to be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6 in Chicago, Illinois and the 2023 European Hematology Association (EHA) Hybrid Congress, being held June 8-11 in Frankfurt, Germany.

Karyopharm to Present New Selinexor Data at the 2023 American Society of Clinical Oncology and European Hematology Association Annual Meetings

Karyopharm Therapeutics, Inc. (NASDAQ:KPTI ) Q1 2023 Earnings Conference Call May 4, 2023 8:00 AM ET Company Participants Elhan Webb - SVP, IR Richard Paulson - President, CEO & Director Sohanya Cheng - EVP & Chief Commercial Officer Reshma Rangwala - Chief Medical Officer Michael Mason - EVP, CFO & Treasurer Conference Call Participants Peter Lawson - Barclays Kevin Strang - Jefferies Colleen Kusy - Robert W. Baird Nicole Gabreski - Piper Sandler Eric Joseph - JPMorgan Operator Good morning.

Karyopharm Therapeutics, Inc. (KPTI) Q1 2023 Earnings Call Transcript

Karyopharm Therapeutics' shares are down more than 18% this year. The company narrowed its net losses year over year.

Why Karyopharm Therapeutics Shares Slumped Thursday

Karyopharm Therapeutics (KPTI) came out with a quarterly loss of $0.30 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.53 per share a year ago.

Karyopharm Therapeutics (KPTI) Reports Q1 Loss, Tops Revenue Estimates

– Achieved First Quarter 2023 Total Revenues of $38.7 Million, including XPOVIO® (selinexor) Net Product Revenue of $28.3 Million, Adversely Impacted by Increased Utilization of  Patient Assistant Programs (PAP) and Higher Gross to Net; YoY Growth in Total Demand1 – – Rapid, Deep and Sustained Spleen and Symptom Responses Observed in the Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis; Planning to Initiate Pivotal Phase 3 Study in Front-Line Myelofibrosis in 1H 2023 – – Single-Agent Eltanexor Showed Encouraging Results with a Median Overall Survival of 8.7 Months in Patients with Higher Risk Relapsed/Refractory Myelodysplastic Neoplasms (MDS) in the Interim Analysis of the Phase 2 Study – –  Company Revises Full Year 2023 Total Revenue Guidance to $145 Million to $160 Million, Including Revised XPOVIO Net Product Revenue Guidance of $110 Million to $125 Million, Reflecting Increased Use of PAP –  – Non-GAAP R&D and SG&A Expense Guidance Revised to $245 Million to $260 Million; Company Re-iterates Cash Runway to Late 2025 – – Conference Call Scheduled for Today at 8:00 a.m. ET – NEWTON, Mass.

Karyopharm Reports First Quarter 2023 Financial Results and Highlights Recent Company Progress

– Relapsed/Refractory MDS Patients Achieved Median Overall Survival of 8.7 months – –  Historically, Median Overall Survival in this Hard to Treat Patient Population is Only 4-6 Months 1,2 – – Results Indicate Potential Single Agent Activity of Eltanexor in Patients with R/R MDS – NEWTON, Mass. , May 3, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced interim data from the Phase 2 portion of the open-label Phase 1/2 study of single-agent eltanexor in patients with higher R/R myelodysplastic neoplasms.

Karyopharm Announces Presentation of Interim Data from Phase 2 Study of Single-Agent Eltanexor in Relapsed/Refractory (R/R) Higher-Risk Myelodysplastic Neoplasms (MDS) at 17th International Congress on MDS

News for Karyopharm Therapeutics Stock (KPTI)