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.

–  Encouraging Data Observed in Phase 1 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Activity Across Three Key Efficacy Endpoints of Spleen Volume Reduction, Symptom Improvement , and Hemoglobin Stabilization, with a Generally Manageable Tolerability Profile and  No Dose Limiting Toxicities – – New Data on Triple Class Refractory Multiple Myeloma Patients Continue to Highlight the Efficacy and Tolerability of Selinexor in the Treatment of Multiple Myeloma – NEWTON, Mass. , Nov. 3, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that two abstracts detailing new selinexor data have been selected for poster presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 10-13, 2022.

Karyopharm Announces New Selinexor Data in Myelofibrosis and Multiple Myeloma to be Presented at ASH 2022

NEWTON, Mass. and FLORENCE, Italy , Nov. 1, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Commission (EC) has granted orphan medicinal product designation for selinexor for the treatment of myelofibrosis (MF).

Karyopharm and Menarini Group Announce Orphan Medicinal Product Designation from the European Commission for Selinexor for the Treatment of Myelofibrosis

-- Conference Call Scheduled for Thursday, November 3, 2022, at 4:30 p.m. ET -- NEWTON, Mass.

Karyopharm to Report Third Quarter 2022 Financial Results on November 3, 2022

Karyopharm's growth strategy has generated significant increases in total revenues, net product revenue growth, licensing revenue, and milestone revenue. Despite the progress, the market continues to punish KPTI. The company is focusing on XPOVIO to maximize growth in multiple myeloma while ensuring their clinical pipeline continues to make progress. I believe Karyopharm has plenty of room to grow.

Karyopharm: Market Is Overlooking Growth

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The company's second-quarter performance had some highlights, but investors might have been concerned about full-year guidance.

Why Karyopharm Therapeutics Inched Higher Today

Karyopharm Therapeutics, Inc. (NASDAQ:KPTI ) Q2 2022 Results Conference Call August 4, 2022 8:00 AM ET Company Participants Elhan Webb - SVP, IR Richard Paulson - President, CEO & Director Sohanya Cheng - EVP & Chief Commercial Officer Mike Mason - EVP, CFO & Treasurer Reshma Rangwala - Chief Medical Officer Conference Call Participants Kevin Strang - Jefferies Peter Lawson - Barclays Mike Ulz - Morgan Stanley Colleen Kusy - Baird Eric Joseph - JP Morgan Ed White - H.C Faisal Khurshid - SVB Securities Operator Good morning, and welcome to the Karyopharm Therapeutics Q2 ‘22 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded.

Karyopharm Therapeutics, Inc. (KPTI) CEO Richard Paulson on Q2 2022 Results - Earnings Call Transcript

– Achieved Second Quarter 2022 Total Revenue of $39.7 Million, Up 76% Versus Second Quarter 2021; XPOVIO® (selinexor) Net Product Revenue of $29.0 Million, a 44% Increase Over Q2 2021 – –  Received  Full Marketing Authorization from the European Commission Expanding Indication for NEXPOVIO® (selinexor) for Treatment of Adults with Multiple Myeloma Who Have Received at Least One Prior Therapy – – Clinical Updates from Phase 1/2 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis and Interim Data from Phase 2 Study Evaluating Eltanexor in Relapsed/Refractory MDS Expected in 2H 2022 – – Company Provides Full Year 2022 Total Revenue Guidance of $155 Million to $165 Million Including Revised XPOVIO Net Product Revenue of $120 Million to $130 Million and non-GAAP R&D and SG&A Expense Guidance of $250 Million to $265 Million; Re-iterates Cash Runway to Early 2024 – – Conference Call Scheduled for Today at 8:00 a.m. ET – NEWTON, Mass.

Karyopharm Reports Second Quarter 2022 Financial Results and Highlights Recent Company Progress

NEWTON, Mass. , Aug. 2, 2022 /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 in a fireside chat at the 2022 Wedbush Pacgrow Healthcare Conference.

Karyopharm to Participate at the 2022 Wedbush Pacgrow Healthcare Conference

-- Conference Call Scheduled for Thursday, August 4, 2022, at 8:00 a.m. ET -- NEWTON, Mass.

Karyopharm to Report Second Quarter 2022 Financial Results on August 4, 2022

– Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication – – Approval Follows Positive Opinion by European Committee for Medicinal Products for Human Use (CHMP) in May 2022 – NEWTON, Mass. and FLORENCE, Italy , July 21, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Commission (EC) has granted Marketing Authorisation for NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy.

Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO® (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy

– FDA Fast Track Designation and European Commission Orphan Medicinal Product Designation Underscore the Significant Need for New Treatment Options for MDS – NEWTON, Mass. , July 20, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced new regulatory designations for eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) investigational compound being studied for the treatment of myelodysplastic syndromes (MDS): (i) the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development program of eltanexor as monotherapy for the treatment of patients with relapsed or refractory intermediate, high-, or very high-risk MDS; (ii) the European Commission (EC) adopted the Committee for Orphan Medicinal Products (COMP) opinion to designate eltanexor as an orphan medicinal product for the treatment of MDS in the European Union (EU).

Karyopharm Granted Regulatory Designations for Eltanexor for the Treatment of Myelodysplastic Syndromes

Biogen

Biogen Inc. (NASDAQ: BIIB) has informed Karyopharm Therapeutics Inc (NASDAQ: KPTI) that it has opted to terminate the companies' Asset Purchase Agreement dated January 24, 2018, as amended. As per the agreement, Karyopharm sold rights of its oral Selective Inhibitor of.

Karyopharm Therapeutics' Shares Slide After Biogen Terminates 2018 Asset Purchase Agreement

– Encouraging Initial Data Observed in Phase 1/2 Study of Selinexor in Combination with Ruxolitinib in Treatment-Naïve Myelofibrosis, Including Favorable Tolerability with No Dose Limiting Toxicities and 75% of Evaluable Patients Demonstrating ≥35% Spleen Volume Reduction (SVR 35) at Week 12 – – FDA Grants Orphan Drug Designation for Selinexor for the Treatment of Myelofibrosis – – Exploratory Subgroup Analyses from SIENDO Trial in Patients with Endometrial Cancer Treated with Selinexor as Maintenance Therapy Identified p53 Wild-type as a Potentially Important Predictor of Efficacy, with 10-month PFS Improvement over Placebo; No Benefit Was Seen in Patients with p53 Mutant Tumors – NEWTON, Mass., May 26, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced promising initial data from a Phase 1/2 study evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and subgroup analyses and molecular classification data from the SIENDO study evaluating selinexor in endometrial cancer.

Karyopharm to Present New Selinexor Data at the 2022 American Society of Clinical Oncology Annual Meeting

- Phase 3 Study Evaluating an All Oral Regimen of Selinexor in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma - ROTTERDAM, Netherlands and NEWTON, Mass. , May 25, 2022 /PRNewswire/ -- The European Myeloma Network (EMN), an international collaborative network of expertise centers for multiple myeloma in Europe and Australia, and Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the dosing of the first patient in the collaborative EMN29/XPORT-MM-031 study, a randomized, global Phase 3 study evaluating an all-oral regimen of selinexor, Karyopharm's first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with Pomalyst® (pomalidomide) and low-dose dexamethasone (SPd) versus Empliciti® (elotuzumab), pomalidomide, and dexamethasone (EPd) in patients with relapsed or refractory multiple myeloma (NCT05028348//EMN29).

The European Myeloma Network and Karyopharm Announce Dosing of First Patient in Collaborative EMN29/XPORT-MM-031 Study

-- European Commission Decision Anticipated within Approximately 60 Days -- NEWTON, Mass. and FLORENCE, Italy , May 20, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly bortezomib (Velcade®) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received one to three prior lines of therapy.

Karyopharm and Menarini Group Receive Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma

SHANGHAI and HONG KONG , May 18, 2022 /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, announces that the uses of XPOVIO®(selinexor) for Multiple Myeloma (MM) patients with first relapse or multiple relapses were incorporated into the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision). This is the first time that selinexor has been included in the guidelines.

Antengene Announces XPOVIO® Treatment Regimens Included for the First Time in the Guidelines for the Diagnosis and Management of Multiple Myeloma in China

-Distribution channels in place to streamline/facilitate patient access. -XPOVIO® will be available in 600 hospitals and 105 DTPs ( across China including Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang, Henan, and Shandong ).

Antengene Announces Commercial Availability of XPOVIO® (Selinexor), for the Treatment of Relapsed/Refractory Multiple Myeloma, Prescribed for the First Time Across Mainland China

SHANGHAI and HONG KONG , May 13, 2022 /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, announces that an abstract related to XPOVIO® (selinexor)  has been selected for presentation at the upcoming 2022 European Hematology Association (EHA2022) Hybrid Congress taking place from June 9-12, 2022 in Vienna, Austria  in person or via virtual attendance: https://ehaweb.org/congress/eha2022-hybrid/eha2022-congress/ The abstract highlights encouraging activity of selinexor plus low-dose dexamethasone  combo (Sd regimen) in a small group of heavily pre-treated patients relapsed/refractory multiple myeloma (R/R MM) previously exposed to chimeric antigen receptor T-cell (CAR-T) therapy within the single-arm, Phase II, registrational MARCH study conducted in China. "Antengene has made it a priority to focus on developing therapies for relapsed and refractory patients with cancer.

Antengene Announces XPOVIO® (selinexor) Data to be Presented at the Upcoming 2022 European Hematology Association Hybrid Congress

NEWTON, Mass. , May 12, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that initial data from a Phase 1 portion of the Ph 1/2 study evaluating selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis has been selected for a poster presentation at the European Hematology Association (EHA) 2022 Hybrid Congress taking place June 9-12, 2022, in Vienna, Austria.

Karyopharm Announces XPOVIO® (selinexor) Data to be Presented at the European Hematology Association 2022 Hybrid Congress

NEWTON, Mass. , May 10, 2022 /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 in a fireside chat at the 2022 RBC Capital Markets Global Healthcare Conference on Tuesday, May 17, 2022 at 4:35 p.m.

Karyopharm to Participate at the 2022 RBC Capital Markets Global Healthcare Conference

Karyopharm Therapeutics, Inc. (NASDAQ:KPTI ) Q1 2022 Earnings Conference Call May 5, 2022 8:30 AM ET Company Participants Elhan Webb - SVP, IR Richard Paulson - President, CEO & Director Sohanya Cheng - EVP & Chief Commercial Officer Michael Mason - EVP, CFO & Treasurer Reshma Rangwala - Chief Medical Officer Patricia Judson - SVP, Medical Strategy Conference Call Participants Maurice Raycroft - Jefferies Peter Lawson - Barclays Bank Michael Ulz - Morgan Stanley Faisal Khurshid - SVB Leerink Edward White - H.C. Wainwright & Co. Eric Joseph - JPMorgan Chase & Co. Colleen Kusy - Robert W.

Karyopharm Therapeutics, Inc. (KPTI) CEO Richard Paulson on Q1 2022 Results - Earnings Call Transcript

KPTI has been devastated by the SIENDO trial failure. The next trial's data will be read out 2 years later.

Karyopharm: Another 2 Year Wait For Data

– Achieved First Quarter 2022 Net Revenues of $47.7 Million, Up 105% Versus First Quarter 2021, Including $19.4 Million License Revenues from Partners – – XPOVIO® (selinexor) Net Product Revenue of $28.3 Million, with a 30% Increase Over Q1 2021 –  – Preliminary Data from Phase 1/2 Trial Evaluating Selinexor in Combination with Ruxolitinib in Patients with Treatment-Naïve Myelofibrosis to Be Presented at ASCO 2022 – – Promising Results from Pre-Specified Exploratory Subgroup Analysis in Patients with p53 Wild-Type Endometrial Cancer from the SIENDO Study; Planning Registration-Enabling Study Targeting Initiation in 2H 2022 –  – Recent Approvals Received by Partner Antengene Continues to Expand XPOVIO's Global Reach –  – Conference Call Scheduled for Today at 8:30 a.m. ET – NEWTON, Mass.

Karyopharm Reports First Quarter 2022 Financial Results and Highlights Recent Company Progress

-- Conference Call Scheduled for Thursday, May 5, 2022, at 8:30 a.m. ET -- NEWTON, Mass.

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