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.

NEWTON, Mass. , Dec. 9, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the appointment of Brendan Strong as Senior Vice President of Investor Relations and Corporate Communications.

Karyopharm Announces the Appointment of Brendan Strong as Senior Vice President of Investor Relations and Corporate Communications

NEWTON, Mass. , Dec. 3, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it is in discussions and has an upcoming meeting with the U.S. Food and Drug Administration (FDA) regarding the evolving treatment landscape in endometrial cancer and any implications this may have with respect to the Company's Phase 3 XPORT-EC-042 trial.

Karyopharm Therapeutics Provides Endometrial Cancer Program Update

NEWTON, Mass. , Dec. 2, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Company granted an aggregate of 4,800 restricted stock units (RSUs) to two newly-hired employees.

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEWTON, Mass. , Nov. 25, 2024 /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 Piper Sandler 36th Annual Healthcare Conference in a fireside chat on Tuesday, December 3 at 11:30 a.m.

Karyopharm to Participate at the Piper Sandler 36th Annual Healthcare Conference

NEWTON, Mass. , Nov. 20, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that Kristin Abate, the Company's Vice President, Accounting, Corporate Controller and Assistant Treasurer has been appointed the Company's Vice President, Chief Accounting Officer, and Assistant Treasurer, effective November 20, 2024.

Karyopharm Therapeutics Announces the Appointment of Chief Accounting Officer

NEWTON, Mass. , Nov. 18, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced abstracts detailing selinexor data have been selected to be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2024 in San Diego, CA.

Karyopharm to Present Selinexor Data at the 66th American Society of Hematology Annual Meeting and Exposition

Karyopharm Therapeutics Inc. (NASDAQ:KPTI ) Q3 2024 Earnings Conference Call November 5, 2024 8:00 AM ET Company Participants Elhan Webb - Senior Vice President, Investor Relations Richard Paulson - President and Chief Executive Officer Reshma Rangwala - Chief Medical Officer Sohanya Cheng - Chief Commercial Officer Michael Mason - Chief Financial Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Ed White - H.C. Wainwright Peter Lawson - Barclays Maury Raycroft - Jefferies Operator Good morning.

Karyopharm Therapeutics Inc. (KPTI) Q3 2024 Earnings Call Transcript

SHANGHAI and HONG KONG , Nov. 5, 2024 /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 medicines for cancer, today announced that it will present the latest data from two clinical studies of selinexor in two Posters at the 2024 American Society of Hematology Annual Meeting (ASH 2024), taking place on December 7-10, 2024, in San Diego, CA, the United States. Details on the Posters: Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study Publication Number: 4748 Session: 654.

Antengene to Present Results from Two Late-Stage Studies of Selinexor Signaling Potential Clinical Breakthrough at ASH 2024

Karyopharm Therapeutics (KPTI) came out with a quarterly loss of $0.26 per share versus the Zacks Consensus Estimate of a loss of $0.27. This compares to loss of $0.30 per share a year ago.

Karyopharm Therapeutics (KPTI) Reports Q3 Loss, Tops Revenue Estimates

– Achieves Third Quarter 2024 Total Revenue of $38.8 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $29.5 Million; Continued Regulatory and Reimbursement Approvals Globally – – Following FDA Alignment, Absolute Change in Total Symptom Score (Abs-TSS) Will Replace TSS50 as a Co-Primary Endpoint in Phase 3 SENTRY Trial in JAKi Naïve Myelofibrosis (MF); Expected Top-line Data Read-out Remains on Track for 2H 2025 – – Narrows Full-Year 2024 Total Revenue Guidance Range to $145.0 Million to $155.0 Million; U.S. XPOVIO Net Product Revenue Guidance Range to $110.0 Million to $115.0 Million; R&D and SG&A Expense Guidance Range to $255.0 Million to $265.0 Million – NEWTON, Mass. , Nov. 5, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the quarter ended September 30, 2024, and highlighted select corporate milestones and progress on its key clinical development programs.

Karyopharm Reports Third Quarter 2024 Financial Results and Highlights Recent Company Progress

Karyopharm Therapeutics (KPTI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Karyopharm Therapeutics (KPTI) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

-- Conference Call Scheduled for Tuesday, November 5, 2024, at 8:00 a.m. ET -- NEWTON, Mass.

Karyopharm to Report Third Quarter 2024 Financial Results on November 5, 2024

Co-primary Endpoint Changed to Absolute Total Symptom Score (Abs-TSS) from Total Symptom Score Improvement of ≥ 50% (TSS50) Following Alignment with the FDA Spleen Volume Response Rate ≥ 35% (SVR35) Remains a Co-primary Endpoint Promising Improvement in Abs-TSS and SVR35 from Phase 1 Trial of Selinexor in Combination with Ruxolitinib Adds Confidence in Phase 3 SENTRY Trial Proactively Increasing Total Sample Size of the SENTRY Trial to Approximately 350 Patients to Further Increase the Statistical Powering; Expected Top-line Data Read-out Remains in 2H 2025 Company to Host a Conference Call Today at 8:00 a.m. ET Featuring Drs.

Karyopharm Announces Favorable Change in Co-Primary Endpoint for Pivotal Phase 3 SENTRY Trial in Myelofibrosis

Company to host a conference call tomorrow at 8:00 a.m. ET NEWTON, Mass.

Karyopharm to Host Investor Event with Leading Myelofibrosis KOLs and Provide a Favorable Study Design Update on October 31, 2024

This approval for XPOVIO® for the treatment of patients with multiple myeloma (MM) marks the third approved indication of the drug in South Korea. To date, XPOVIO® has already been included in national health insurance or reimbursement schemes in South Korea, the mainland of China, Australia and Singapore, and is expected to achieve national reimbursement coverage in more APAC markets.

Antengene Announces XPOVIO® (selinexor) Approved for Its Third Indication in South Korea, Bringing Fresh Hope to Patients with MM in the Country

XPOVIO® is the first and only approved XPO1 inhibitor in Thailand. XPOVIO® has been approved for multiple indications in nine markets across the APAC region.

Antengene Announces XPOVIO® (selinexor) Approved for Commercialization in Thailand

Karyopharm Therapeutics (KPTI) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.

Down -12.14% in 4 Weeks, Here's Why Karyopharm Therapeutics (KPTI) Looks Ripe for a Turnaround

NEWTON, Mass. , Sept. 3, 2024 /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 the following investor conferences in September: H.C.

Karyopharm to Participate at Upcoming Investor Conferences

Karyopharm Therapeutics (KPTI) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to loss of $0.29 per share a year ago.

Karyopharm Therapeutics (KPTI) Reports Q2 Loss, Tops Revenue Estimates

– Achieves Second Quarter 2024 Total Revenue of $42.8 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $28.0 Million; Positive Momentum ex-US with Continued Regulatory and Reimbursement Approvals – – Updated Clinical Results at ASCO Annual Meeting Showed Median Progression-Free Survival (PFS) of 28.4 Months in the TP53 Wild-Type Exploratory Subgroup and 39.5 Months in the Proficient Mismatched Repair Status (pMMR) TP53 Wild-Type Exploratory Subgroup from Phase 3 SIENDO Study of Selinexor Maintenance Treatment in Advanced/Recurrent Endometrial Cancer – – Pre-Clinical Data Presented at the June 2024 European Hematology Association Meeting Support Selinexor's Mechanism of Action Targeting Multiple Oncogenic Pathways beyond JAK/STAT and Builds on the Compelling Clinical Data in Myelofibrosis – – Completed Significant Refinancing Transactions and Amended Royalty Agreement with HealthCare Royalty Extending Vast Majority of Its Debt Maturities into 2028 and 2029, Well Beyond Expected Data Readouts and Potential Approvals from the Company's Three Phase 3 Trials, Strengthening the Company for its Next Stage of Growth – –  Raises the Lower End of Full-Year 2024 Total Revenue Guidance to $145.0 Million to $160.0 Million and U.S. XPOVIO Net Product Revenue Guidance to $105.0 Million to $120.0 Million; Lowers Full Year 2024 R&D and SG&A Expense Guidance to $250.0 Million to $265.0 Million – NEWTON, Mass. , Aug. 6, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the quarter ended June 30, 2024, and highlighted select corporate milestones and progress on its key clinical development programs.

Karyopharm Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress

XPOVIO® is the first and only approved XPO1 inhibitor in Malaysia. XPOVIO® has been approved for multiple indications in eight markets across the APAC region.

Antengene Announces XPOVIO® (selinexor) Approved for Commercialization in Malaysia

-- Conference Call Scheduled for Tuesday, August 6, 2024, at 8:00 a.m. ET -- NEWTON, Mass.

Karyopharm to Report Second Quarter 2024 Financial Results on August 6, 2024

- Following its initial approval for the treatment of relapsed/refractory multiple myeloma (R/R MM), XPOVIO® has now received approval as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) marking the second approved indication of XPOVIO® in China. - Results from the registrational SEARCH study in China showed that the overall response rate (ORR) among the 60 Chinese patients treated with XPOVIO® met the study's prespecified primary endpoint.

XPOVIO® (selinexor) Approved for New Indication in DLBCL in China, Bringing a New Treatment Option to Patients in the Country

- XPOVIO® is the first XPO1 inhibitor approved for reimbursement by South Korea's National Health Insurance Service (NHIS) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM). - The approval of XPOVIO® by the NHIS in South Korea is the fourth national reimbursement in the Antengene markets after mainland of China, Australia and Singapore.

Antengene Announces XPOVIO® (selinexor) National Health Insurance Service Approval for Reimbursement in South Korea

Long-Term Follow-Up Data Signal Promising Progression-Free Survival (PFS) for Selinexor in the Maintenance Setting with Median PFS of 28.4 Months in the TP53 Wild-Type and 39.5 Months in the Proficient Mismatched Repair Status (pMMR) TP53 Wild-Type Exploratory Subgroups Q-TWiST, an Important Metric Assessing Both Quality and Quantity of Clinical Benefit, Suggests Improvement with Selinexor versus Placebo, which is Critical in the Maintenance Setting Company Highlights Additional Presentations in Endometrial Cancer and Myelofibrosis at ASCO 2024 NEWTON, Mass. , June 1, 2024 /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 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Karyopharm Presents Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer During 2024 ASCO Plenary Series: Rapid Abstract Updates

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