KPTI Karyopharm Therapeutics Inc.

10.02
-0.12  -1%
Previous Close 10.14
Open 10.07
52 Week Low 9.75
52 Week High 25.9794
Market Cap $747,835,596
Shares 74,634,291
Float 70,966,452
Enterprise Value $643,013,346
Volume 1,084,408
Av. Daily Volume 2,507,538
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Upcoming Catalysts

Drug Stage Catalyst Date
Selinexor - SIENDO
Endometrial cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Selinexor - SEAL
Dedifferentiated liposarcoma
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 2, 2020.
KPT-9274
Non-Hodgkin Lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 ongoing.
Selinexor
COVID-19 Coronavirus
Phase 2
Phase 2
Phase 2 data noted unlikely to demonstrate efficacy benefit across entire patient population with benefit in a clearly defined subpopulation of patients.
Selinexor
Multiple myeloma
Approved
Approved
FDA approval announced December 18, 2020.
Selinexor
Diffuse Large B-Cell Lymphoma (DLBCL)
Approved
Approved
FDA Approval announced June 22, 2020.
Selinexor
Glioblastoma
Phase 1/2
Phase 1/2
Phase 1/2 commencement of dosing announced June 9, 2020.
Selinexor
Quadruple Refractory Multiple Myeloma
Approved
Approved
FDA Approval announced July 3, 2019.
Selinexor - SIRRT
Richter's transformation
Phase 2
Phase 2
Phase 2 trial terminated.
Selinexor - SHIP
Cancer - hormone-refractory prostate cancer (HRPC)
Phase 2
Phase 2
Phase 2 trial terminated.
Selinexor SOPRA
Cancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)
Phase 2
Phase 2
Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.

Latest News

  1. SHANGHAI and HONG KONG, April 5, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, today announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase I clinical trial to evaluate safety and tolerability of ATG-019 (monotherapy or combined with niacin ER) in patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL) in China.

    As an orally bioavailable dual PAK4/NAMPT inhibitor, ATG-019 can lead to antitumor effects through energy depletion, inhibition…

    SHANGHAI and HONG KONG, April 5, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, today announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for a Phase I clinical trial to evaluate safety and tolerability of ATG-019 (monotherapy or combined with niacin ER) in patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL) in China.

    As an orally bioavailable dual PAK4/NAMPT inhibitor, ATG-019 can lead to antitumor effects through energy depletion, inhibition of DNA repair, cell cycle arrest, inhibition of proliferation, and ultimately cell apoptosis. Hematological and solid tumor cells that are dependent on both PAK4 and NAMPT pathways may be susceptible to single-agent anti-tumor activity by ATG-019. ATG-019 has clear preclinical anti-tumor activity and a superior pharmacokinetics (PK) and safety profile making it an attractive novel drug candidate. Antengene has recently been conducting a Phase I clinical trial (TEACH) of ATG-019 in advanced solid tumors and NHL in Taiwan.

    "The NMPA's approval of the IND application for ATG-019 indicates the potential of this drug to be applied to Chinese patients. We look forward to initiating the first clinical trial of ATG-019 in mainland China," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "ATG-019 is an orally available dual PAK4/NAMPT inhibitor that achieves synergistic antitumor effects through the co-inhibition of the two pathways. We believe that ATG-019, as a novel agent under investigation, can potentially provide an additional treatment option for patients with advanced solid tumor and NHL."

    About ATG-019

    ATG-019 is a global first-in-class oral dual PAK4/NAMPT inhibitor developed by Karyopharm Therapeutics Inc. (NASDAQ:KPTI). Antengene reached an exclusive agreement of cooperation and authorization with Karyopharm and obtained the exclusive development and commercialization rights of ATG-019 in multiple Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and ASEAN countries.

    PAK4 is a signaling protein regulating numerous fundamental cellular processes, including intracellular transport, cellular division, cell shape and motility, cell survival, immune defense and the development of cancer. PAK4 interacts with many key signaling molecules involved in cancer development such as beta-catenin, CDC42, Raf-1, BAD and myosin light chain. NAMPT is a pleiotropic protein with intra- and extra-cellular functions as an enzyme, cytokine, growth factor, and hormone that can be found in a complex with PAK4 in the cell. In preclinical mouse models, ATG-019 in combination with anti-PD-1 therapies showed improved antitumor efficacy over anti-PD-1 monotherapy, indicating the potential of the combined therapy to treat anti-PD-1 resistant patients.

    Antengene is conducting a Phase I clinical trial of ATG-019 in Taiwan in patients with advanced NHL and solid tumors and are planning to conduct clinical trials exploring its combination potential with other agents.

    About Antengene

    Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region, and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets and obtained 13 investigational new drug approvals in Asia Pacific. The vision of Antengene is to "Treat Patients Beyond Borders". Antengene aims to address significant unmet medical needs by discovering, developing, and commercializing first-in-class/best-in-class therapeutics.

    Forward-looking statements

    The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

     

    Cision View original content:http://www.prnewswire.com/news-releases/antengene-announces-nmpa-approval-of-ind-application-for-atg-019-in-patients-with-advanced-solid-tumors-or-non-hodgkins-lymphoma-301262443.html

    SOURCE Antengene Corporation Limited

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  2. NEWTON, Mass., April 1, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Compensation Committee of Karyopharm's Board of Directors granted stock options to purchase an aggregate of 150,600 shares of Karyopharm's common stock to 15 newly-hired employees, with a grant date of March 31, 2021.  The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each of the stock options has an exercise price of $10.52 per share, the closing price of Karyopharm's common stock on March 31, 2021. Each stock option vests over four years…

    NEWTON, Mass., April 1, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Compensation Committee of Karyopharm's Board of Directors granted stock options to purchase an aggregate of 150,600 shares of Karyopharm's common stock to 15 newly-hired employees, with a grant date of March 31, 2021.  The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each of the stock options has an exercise price of $10.52 per share, the closing price of Karyopharm's common stock on March 31, 2021. Each stock option vests over four years, with 25% of the total number of shares underlying the stock option vesting on the one-year anniversary of the applicable employee's employment commencement date and 1/48th of the total number of shares vesting monthly thereafter, subject to the employee's continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each stock option will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee's employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable stock option agreement).

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead 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 heavily pretreated multiple myeloma and as a monotherapy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. 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. For more information, please visit www.karyopharm.com.

    Cision View original content:http://www.prnewswire.com/news-releases/karyopharm-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301260328.html

    SOURCE Karyopharm Therapeutics Inc.

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  3. NEWTON, Mass., March 29, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Commission (EC) has granted conditional marketing authorization for NEXPOVIO (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

    Conditional marketing authorization…

    NEWTON, Mass., March 29, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Commission (EC) has granted conditional marketing authorization for NEXPOVIO (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

    Conditional marketing authorization is supported by data from the positive Phase 2b STORM study, which evaluated selinexor in adult patients with heavily pretreated, triple class refractory multiple myeloma and was published in the New England Journal of Medicine (Chari, et al.) in August 2019.  Under the provisions of conditional approval by the EC, continued authorization for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial and is subject to additional monitoring. An EC marketing authorization through the centralized procedure (CP) is valid in all 27 European Union (EU) member countries, as well as the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.

    "NEXPOVIO represents the first and only nuclear export inhibitor authorized in Europe and we are delighted to bring this new treatment option to eligible adult patients with heavily pretreated multiple myeloma. Despite advancements in the treatment of multiple myeloma, most adult patients will eventually relapse and develop disease that is refractory to all authorized therapies, further highlighting the urgent need for new therapies with novel mechanism of actions like NEXPOVIO," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "Our first product authorization in Europe could not have been possible without the dedication of the patients, caregivers, physicians and Karyopharm employees involved in the clinical development of NEXPOVIO over the last 13 years."

    "Today's authorization is an important step forward in the international expansion of selinexor, now with marketing authorization for use in Europe, Israel and the U.S.," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "We are committed to making NEXPOVIO available in Europe initially through a Named Patient Program and are on track to submit a second European regulatory filing in April based on the positive data from the Phase 3 BOSTON study to potentially further expand NEXPOVIO to eligible adult patients in need of new treatment options."

    About the Phase 2b STORM Pivotal Trial

    The Phase 2b STORM trial (Selinexor Treatment of Refractory Myeloma) was an international, multi-center, single-arm, open-label study which enrolled 123 adult patients (Part 2 of the trial) with heavily pretreated, triple class refractory multiple myeloma. Adult patients in the trial had a median of seven previous therapeutic regimens, including a median of 10 unique anti-myeloma agents.

    For the study's primary endpoint, oral selinexor achieved an overall response rate of 26% (95% confidence interval [CI], 19, 35) and the trial therefore met its primary endpoint (n=123). Minimal response per IMWG criteria was observed in 16 (13%) patients and 48  patients (39%) had stable disease. All responses were adjudicated by an Independent Review Committee. Among the modified intent to treat population enrolled in STORM Part 2, eighty–three (83) patients had relapse and/or refractory multiple myeloma that was refractory to two proteasome inhibitors (bortezomib, carfilzomib), two immunomodulators (lenalidomide, pomalidomide) and an anti-CD38 monoclonal antibody (daratumumab), the efficacy analysis was based on these 83 patients. A secondary efficacy endpoint included overall survival (OS), defined as the duration from start of study treatment to death due to any cause. The median OS was 8.6 months in the total population (n=123) studied and 15.6 months in adult patients who had a minimal response or better.

    Karyopharm's request for conditional authorization in Europe was based upon the same patient population that served as the basis for XPOVIO's accelerated FDA approval in the U.S. The overall response rate in this patient population (n=83) was 25.3 % (95% confidence interval [CI], 16.4, 36).

    The most common adverse reactions in the STORM trial (≥20%) were thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of adult patients. Serious adverse reactions occurred in 58% of adult patients. Treatment discontinuation rate due to adverse reactions was 27%.

    About Multiple Myeloma in Europe

    Multiple myeloma (MM) is an incurable cancer with significant morbidity and the second most common hematologic malignancy. In 2020, there were approximately 51,000 new cases and 32,000 deaths from MM in Europe1. While the treatment of MM has improved over the last 20 years, and overall survival has increased considerably, the disease remains incurable, and nearly all adult patients will eventually relapse and develop disease that is refractory to all authorized anti-MM therapies. Therefore, there continues to be a high unmet medical need for new therapies, particularly those with novel mechanisms of action.

    About NEXPOVIO (selinexor)

    NEXPOVIO, which is marketed as XPOVIO® in the U.S., is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. NEXPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). NEXPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. NEXPOVIO (selinexor) has been granted conditional marketing authorization by the European Commission in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

    Therapeutic indication for NEXPOVIO in the EU as well as The EEA Countries of Iceland, Liechtenstein and Norway

    NEXPOVIO is indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

    SELECT IMPORTANT SAFETY INFORMATION 

    NEXPOVIO is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.

    Contraindications: Hypersensitivity to selinexor.

    Special warnings and precautions for use:

    Recommended concomitant treatments

    Adult patients should be advised to maintain adequate fluid and caloric intake throughout treatment. Intravenous hydration should be considered for adult patients at risk of dehydration.

    Prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents should be provided prior to and during treatment with NEXPOVIO.

    Haematology

    Adult patients should have their complete blood counts (CBC) assessed at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment.

    Thrombocytopenia: Thrombocytopenic events (thrombocytopenia and platelet count decreased) were frequently reported in adult patients receiving selinexor, which can be severe (Grade 3/4). Adult patients should be monitored for signs and symptoms of bleeding and evaluated promptly.

    Neutropenia:  Severe neutropenia (Grade 3/4) has been reported with selinexor.

    Adult patients with neutropenia should be monitored for signs of infection and evaluated promptly.

    Gastrointestinal toxicity: Nausea, vomiting, diarrhoea, which sometimes can be severe and may require the use of anti-emetic and anti-diarrhoeal medicinal products.

    Weight loss and anorexia: Adult patients should have their body weight, nutritional status and volume checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

    Confusional state and dizziness: Patients should be instructed to avoid situations where dizziness or confusional state may be a problem and to not take other medicinal products that may cause dizziness or confusional state without adequate medical advice. Patients should be advised not to drive or operate heavy machinery until symptoms resolve.

    Hyponatraemia: Adult patients should have their sodium levels checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

    Tumour lysis syndrome (TLS): TLS has been reported in adult patients receiving therapy with selinexor. Adult patients at a high risk for TLS should be monitored closely. Treat promptly in accordance with institutional guidelines.

    Fertility, pregnancy and lactation

    Women of childbearing potential/contraception in males and females: Women of childbearing potential and male adult patients of reproductive potential should be advised to use effective contraceptive measures or abstain from sexual activity to prevent pregnancy during treatment with selinexor and for at least 1 week following the last dose of selinexor.

    Breast-feeding: It is unknown whether selinexor or its metabolites are excreted in human milk. A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during treatment with selinexor and for 1 week after the last dose.

    Elderly population

    Patients 75 years and older had a higher incidence of discontinuation due to an adverse reaction, higher incidence of serious adverse reactions, and higher incidence of fatal adverse reactions.

    Undesirable effects

    Summary of the safety profile

    The most frequent adverse reactions (≥30%) of selinexor in combination with dexamethasone were nausea, thrombocytopenia, fatigue, anaemia, decreased appetite, decreased weight, diarrhoea, vomiting, hyponatraemia, neutropenia and leukopenia.

    The most commonly reported serious adverse reactions (≥3%) were pneumonia, sepsis, thrombocytopenia, acute kidney injury, and anaemia.

    Description of selected adverse reactions

    Infections: Infection was the most common non-haematological toxicity. Upper respiratory tract infection and pneumonia were the most commonly reported infections with 25% of reported infections being serious and fatal infections occurring in 3% of treated adult patients.

    Reporting of suspected adverse reactions

    Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

    Please see NEXPOVIO Summary of Product Characteristics and European Public Assessment Report Once Made Available by the EC

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead 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 heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. 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. For more information, please visit www.karyopharm.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Karyopharm's expectations and plans relating to XPOVIO/NEXPOVIO for the treatment of adult patients with relapsed or refractory multiple myeloma and/or relapsed or refractory diffuse large B-cell lymphoma; commercialization of XPOVIO/NEXPOVIO or any of its drug candidates and the commercial performance of XPOVIO/NEXPOVIO; submissions to, and the review and potential authorization of selinexor by, regulatory authorities, including the Company's regulatory strategy, the anticipated availability of data to support such submissions, timing of such submissions and actions by regulatory authorities; the expected design of the Company's clinical trials; and the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, especially selinexor. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond Karyopharm's control, that may cause actual events or results to differ materially from Karyopharm's current expectations. For example, there can be no guarantee that Karyopharm will successfully commercialize XPOVIO/NEXPOVIO; that regulators will grant confirmatory authorization in the European Union based on the BOSTON study in adult patients with multiple myeloma; or that any of Karyopharm's drug candidates, including selinexor, will successfully complete necessary clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in the development or commercialization of Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the risk that the COVID-19 pandemic could disrupt Karyopharm's business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO/NEXPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO/NEXPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO/NEXPOVIO or any of Karyopharm's drug candidates that receive regulatory authorization; the ability to obtain and retain regulatory authorization of XPOVIO/NEXPOVIO or any of Karyopharm's drug candidates that receive regulatory authorization; Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development or regulatory authorization of drug candidates by Karyopharm's competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any product or product candidate. These and other risks are described under the caption "Risk Factors" in Karyopharm's Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on February 24, 2021, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited.

    References 

    World Health Organization. 2020. https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf

     

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    SOURCE Karyopharm Therapeutics Inc.

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  4. Adoption of additional technology solutions demonstrates commitment to patients with cancer and other serious diseases

    Medidata, a Dassault Systèmes company and the global leader in creating end-to-end solutions to support the entire clinical development process, today announced its expanded partnership with Karyopharm Therapeutics (NASDAQ:KPTI). In 2014, Karyopharm selected one Medidata technology solution for a single study. Today, the company is leveraging 10 solutions in Medidata Rave Clinical Cloud in more than 15 clinical studies focused on hematologic malignancies and solid tumors.

    "Medidata is pleased to play a key role in supporting Karyopharm's mission of bringing novel therapies to market, providing hope for patients," said Glen…

    Adoption of additional technology solutions demonstrates commitment to patients with cancer and other serious diseases

    Medidata, a Dassault Systèmes company and the global leader in creating end-to-end solutions to support the entire clinical development process, today announced its expanded partnership with Karyopharm Therapeutics (NASDAQ:KPTI). In 2014, Karyopharm selected one Medidata technology solution for a single study. Today, the company is leveraging 10 solutions in Medidata Rave Clinical Cloud in more than 15 clinical studies focused on hematologic malignancies and solid tumors.

    "Medidata is pleased to play a key role in supporting Karyopharm's mission of bringing novel therapies to market, providing hope for patients," said Glen de Vries, co-founder and co-CEO, Medidata. "This agreement is a clear demonstration of our shared mission to advance analytics and technology to make a difference in health care."

    With Medidata solutions, Karyopharm is able to:

    • Centralize operations, eliminate manual data entry, and operate with a clear view of all cross-application data in one place
    • Simplify and customize reporting within or across studies and leverage over 30 standard reports
    • Reduce complexity by standardizing and improving data quality with powerful artificial intelligence and machine learning algorithms that automatically manage the complexity of clinical data

    "Medidata continues to be an important strategic partner for Karyopharm by providing a cutting-edge technological infrastructure that helps us reach our clinical trial goals," said Kristan Gallitano, senior vice president, Development Operations at Karyopharm. "Medidata provides us the flexible, scalable technology and support we need to meet the evolving challenges of drug development."

    Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

    About Medidata

    Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,700+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata.

    Medidata is a registered trademark of Medidata Solutions, Inc., a wholly owned subsidiary of Dassault Systèmes.

    About Dassault Systèmes

    Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systèmes brings value to more than 290,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.

    3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, EXALEAD, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French "société européenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.

    About Karyopharm

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma and in December 2020 in combination with Velcade® (bortezomib) and dexamethasone as a treatment for patients with multiple myeloma after at least one prior therapy. In June 2020, XPOVIO was approved by the FDA as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma. A Marketing Authorization Application for selinexor for patients with heavily pretreated multiple myeloma is also currently under review by the European Medicines Agency. 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. For more information, please visit www.karyopharm.com.

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  5. NEWTON, Mass., March 1, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Compensation Committee of Karyopharm's Board of Directors granted stock options to purchase an aggregate of 93,600 shares of Karyopharm's common stock to 11 newly-hired employees, with a grant date of February 26, 2021.  The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each of the stock options has an exercise price of $13.82 per share, the closing price of Karyopharm's common stock on February 26, 2021. Each stock option vests over four…

    NEWTON, Mass., March 1, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Compensation Committee of Karyopharm's Board of Directors granted stock options to purchase an aggregate of 93,600 shares of Karyopharm's common stock to 11 newly-hired employees, with a grant date of February 26, 2021.  The stock options were granted as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

    Each of the stock options has an exercise price of $13.82 per share, the closing price of Karyopharm's common stock on February 26, 2021. Each stock option vests over four years, with 25% of the total number of shares underlying the stock option vesting on the one-year anniversary of the applicable employee's employment commencement date and 1/48th of the total number of shares vesting monthly thereafter, subject to the employee's continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each stock option will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee's employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable stock option agreement).

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead 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 patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma. A Marketing Authorization Application for NEXPOVIO® (selinexor) for patients with heavily pretreated multiple myeloma is also currently under review by the European Medicines Agency. 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. For more information, please visit www.karyopharm.com.

    Cision View original content:http://www.prnewswire.com/news-releases/karyopharm-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301237711.html

    SOURCE Karyopharm Therapeutics Inc.

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