KPTI Karyopharm Therapeutics Inc.

14.84
+0.14  (+1%)
Previous Close 14.7
Open 14.74
52 Week Low 8.915
52 Week High 29.61
Market Cap $1,090,416,533
Shares 73,478,203
Float 69,810,364
Enterprise Value $921,531,532
Volume 2,115,291
Av. Daily Volume 1,414,268
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Selinexor - SEAL
Dedifferentiated liposarcoma
Phase 2/3
Phase 2/3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Selinexor
Multiple myeloma
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
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
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.
Eltanexor
Solid tumors
Phase 2
Phase 2
Phase 2 data reported at ASCO-GU 2019.
Selinexor - SIENDO
Endometrial cancer
Phase 3
Phase 3
Phase 3 enrolment to be completed 2020.
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. NEWTON, Mass., Sept. 14, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that four abstracts have been selected for poster presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 taking place from September 19-21. Three abstracts from investigator-sponsored studies will feature clinical data related to XPOVIO (selinexor), the Company's first in class, oral Selective Inhibitor of Nuclear Export (SINE) compound, including: (i) combination data with pembrolizumab for the treatment of melanoma, (ii) combination data with carboplatin and paclitaxel for the treatment of advanced or metastatic solid tumors, and…

    NEWTON, Mass., Sept. 14, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that four abstracts have been selected for poster presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 taking place from September 19-21. Three abstracts from investigator-sponsored studies will feature clinical data related to XPOVIO (selinexor), the Company's first in class, oral Selective Inhibitor of Nuclear Export (SINE) compound, including: (i) combination data with pembrolizumab for the treatment of melanoma, (ii) combination data with carboplatin and paclitaxel for the treatment of advanced or metastatic solid tumors, and (iii) combination data with topotecan for the treatment of advanced or metastatic solid tumors. A fourth abstract highlights the use of machine learning algorithms to investigate characteristics associated with XPOVIO tolerability and efficacy.

    "We are excited to share additional clinical data from multiple XPOVIO studies at ESMO this year, further highlighting XPOVIO's potential application in solid tumors, an important area for future pipeline expansion," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "We are particularly encouraged by data from the Phase 1b study of XPOVIO in combination with pembrolizumab, which showed significant clinical activity as frontline therapy compared to historic frontline single-agent pembrolizumab in patients with metastatic non-uveal melanoma. In addition, XPOVIO in combination with carboplatin and paclitaxel conferred appreciable clinical activity with durable objective responses, providing an opportunity for further exploration in tumor types where carboplatin and paclitaxel chemotherapy is used as the standard of care. The encouraging results from these combination studies warrant further research into the potential utility of XPOVIO in solid tumors."

    Details for the ESMO poster presentations are as follows:

    Title: Phase 1b study to evaluate the safety of selinexor (KPT-330) in combination with pembrolizumab in patients with advanced malignancies - the melanoma experience

    Presenter: Isabella C. Glitza Oliva, MD Anderson Cancer Center

    Presentation Number: 1124P

    Date: Available on demand on Thursday, September 17, 2020

    Title: Selinexor in combination with carboplatin and paclitaxel in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multi-arm phase 1b study

    Presenter: Kyaw Z. Thein, MD Anderson Cancer Center

    Presentation Number: 554P

    Date: Available on demand on Thursday, September 17, 2020

    Title: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multi-arm phase 1b study

    Presenter: Kyaw Z. Thein, MD Anderson Cancer Center

    Presentation Number: 565P

    Date: Available on demand on Thursday, September 17, 2020

    Title: Machine learning models predict selinexor tolerability and efficacy

    Presenter: Yuval Artstein, Karyopharm Therapeutics Inc.

    Presentation Number: 89P

    Date: Available on demand on Thursday, September 17, 2020

    About XPOVIO® (selinexor)

    XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO 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. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm's supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

    IMPORTANT SAFETY INFORMATION

    Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

    Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.

    Neutropenia: XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection. Neutropenia and febrile neutropenia occurred in patients with MM and in patients with DLBCL. Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction (AR).

    Gastrointestinal Toxicity: XPOVIO can cause severe gastrointestinal toxicities in patients with MM and DLBCL.

    Nausea/Vomiting: Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.

    Diarrhea: Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration, and replace electrolytes as clinically indicated.

    Anorexia/Weight Loss: Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated.

    Hyponatremia: XPOVIO can cause severe or life-threatening hyponatremia. Hyponatremia developed in patients with MM and in patients with DLBCL.

    Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first 2 months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose, or permanently discontinue based on severity of the AR.

    Serious Infection: XPOVIO can cause serious and fatal infections. Most infections were not associated with Grade 3 or higher neutropenia. Atypical infections reported after taking XPOVIO include, but are not limited to, fungal pneumonia and herpesvirus infection.

    Monitor for signs and symptoms of infection, and evaluate and treat promptly.

    Neurological Toxicity: XPOVIO can cause life-threatening neurological toxicities.

    Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.

    Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate.

    Embryo-Fetal Toxicity: XPOVIO can cause fetal harm when administered to a pregnant woman.

    Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

    ADVERSE REACTIONS

    The most common adverse reactions (ARs) in ≥20% of patients with MM are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

    The most common ARs, excluding laboratory abnormalities, in ≥20% of patients with DLBCL are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities in ≥15% of patients included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in ≥5% were thrombocytopenia, lymphopenia, and neutropenia.

    In patients with MM, fatal ARs occurred in 9% of patients. Serious ARs occurred in 58% of patients. Treatment discontinuation rate due to ARs was 27%. The most frequent ARs requiring permanent discontinuation in ≥4% of patients included fatigue, nausea, and thrombocytopenia.

    In patients with DLBCL, fatal ARs occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal AR was infection (4.5% of patients). Serious ARs occurred in 46% of patients; the most frequent serious AR was infection. Discontinuation due to ARs occurred in 17% of patients.

    USE IN SPECIFIC POPULATIONS

    In MM, no overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients. Patients ≥75 years old had a higher incidence of discontinuation due to an AR than younger patients, a higher incidence of serious ARs, and a higher incidence of fatal ARs. Clinical studies in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

    The effect of end-stage renal disease (CLCR <15 mL/min) or hemodialysis on XPOVIO pharmacokinetics is unknown.

    To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see XPOVIO Full Prescribing Information available at www.XPOVIO.com.

    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), 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. 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.

    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 beliefs regarding the ability of selinexor to treat patients with myeloma, solid tumors and other diseases and expectations related to future clinical development and potential regulatory submissions of XPOVIO. 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; that regulators will agree that selinexor qualifies for conditional approval in the E.U. as a result of data from the STORM study or confirmatory approval in the U.S. or EU based on the BOSTON study in patients with relapsed or refractory 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, 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 in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; 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 obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which was filed with the Securities and Exchange Commission (SEC) on August 4, 2020, 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.

    Cision View original content:http://www.prnewswire.com/news-releases/karyopharm-announces-xpovio-selinexor-clinical-data-to-be-presented-at-european-society-for-medical-oncology-virtual-congress-2020-301130144.html

    SOURCE Karyopharm Therapeutics Inc.

    View Full Article Hide Full Article
  2. NEWTON, Mass., Sept. 2, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that Michael Kauffman, MD, PhD, Chief Executive Officer of Karyopharm, will participate in a fireside chat at Baird's 2020 Global Healthcare Conference and at the Morgan Stanley 18th Annual Global Healthcare Conference. Details regarding these September conferences are below.

    Baird's 2020 Global Healthcare Conference
    Date: Wednesday, September 9
    Time: 10:15 AM ET

    Morgan Stanley's 18th Annual Global Healthcare Conference
    Date: Tuesday, September 15
    Time: 5:00 PM ET

    A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section…

    NEWTON, Mass., Sept. 2, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that Michael Kauffman, MD, PhD, Chief Executive Officer of Karyopharm, will participate in a fireside chat at Baird's 2020 Global Healthcare Conference and at the Morgan Stanley 18th Annual Global Healthcare Conference. Details regarding these September conferences are below.

    Baird's 2020 Global Healthcare Conference

    Date: Wednesday, September 9

    Time: 10:15 AM ET

    Morgan Stanley's 18th Annual Global Healthcare Conference

    Date: Tuesday, September 15

    Time: 5:00 PM ET

    A live webcast of the fireside chats can be accessed under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. A replay of the webcast will be archived on the Company's website for 90 days following each fireside chat.

    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), 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. 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.

    Cision View original content:http://www.prnewswire.com/news-releases/karyopharm-announces-september-2020-virtual-investor-conference-participation-301122423.html

    SOURCE Karyopharm Therapeutics Inc.

    View Full Article Hide Full Article
  3. NEWTON, Mass., Sept. 1, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), an innovation-driven pharmaceutical company, today announced that the Compensation Committee of Karyopharm's Board of Directors granted stock options to purchase an aggregate of 29,600 shares of Karyopharm's common stock to seven newly-hired employees, with a grant date of August 31, 2020.  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 $15.21 per share, the closing price of Karyopharm's common stock on August 31, 2020. Each stock option vests over four years, with 25% of the total…

    NEWTON, Mass., Sept. 1, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), an innovation-driven pharmaceutical company, today announced that the Compensation Committee of Karyopharm's Board of Directors granted stock options to purchase an aggregate of 29,600 shares of Karyopharm's common stock to seven newly-hired employees, with a grant date of August 31, 2020.  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 $15.21 per share, the closing price of Karyopharm's common stock on August 31, 2020. 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), 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. 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.

     

    Cision View original content:http://www.prnewswire.com/news-releases/karyopharm-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301122237.html

    SOURCE Karyopharm Therapeutics Inc.

    View Full Article Hide Full Article
  4. NEWTON, Mass., Aug. 31, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the appointment of Christy J. Oliger to its Board of Directors. Ms. Oliger is the former Senior Vice President of the Oncology Business Unit at Genentech, a leading biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Ms. Oliger served in a wide variety of commercial leadership positions at Genentech from 2000 until 2020. Genentech is a member of the Roche Group, the world's largest biotech company and the global leader in cancer treatments and has been at the forefront…

    NEWTON, Mass., Aug. 31, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the appointment of Christy J. Oliger to its Board of Directors. Ms. Oliger is the former Senior Vice President of the Oncology Business Unit at Genentech, a leading biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Ms. Oliger served in a wide variety of commercial leadership positions at Genentech from 2000 until 2020. Genentech is a member of the Roche Group, the world's largest biotech company and the global leader in cancer treatments and has been at the forefront of cancer research and treatment for over 50 years.

    "Ms. Oliger is a pharmaceutical industry leader who brings broad commercial, portfolio management, and leadership experience having played a critical role in Genentech's significant commercial success over the past twenty years," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "Her strategic expertise and counsel will be critical to Karyopharm as we continue to expand the global development and commercialization of XPOVIO® into different patient populations and potential new indications. On behalf of the Board of Directors and our executive leadership team, we welcome Ms. Oliger and look forward to her contributions."

    Ms. Oliger brings over 25 years of biopharmaceutical industry experience, including various leadership roles in sales and marketing, portfolio management, and overseeing multiple business units at Genentech in oncology, rare diseases, neuroscience, and hematology. She was responsible for the U.S. oncology business unit and oncology pipeline, which generated over $13 billion of sales in 2019.

    "It is a privilege to be joining Karyopharm's Board of Directors, especially as the company prepares to expand its reach into a variety of new patient populations with high unmet medical need," said Ms. Oliger.  "The therapeutic potential of XPOVIO is exciting given its innovative mechanism of action, oral administration and increasing body of clinical evidence.  I look forward to working with the Karyopharm Board and management team through what I believe will be an era of significant growth for the Company, while making a significant impact on people living with cancer."

    Prior to joining Genentech, Ms. Oliger had an 8-year career at Schering-Plough Corporation where she held numerous positions of increasing responsibility within the sales and marketing organization. Ms. Oliger holds a bachelor's degree in Economics from the University of California at Santa Barbara.

    "Ms. Oliger is a driven, strategically-focused, biopharmaceutical leader who has an impeccable record of success in oncology and who has demonstrated a deep commitment to patients," said Barry Greene, lead independent Director and Chair of the Nominating, Corporate Governance & Compliance Committee. "This appointment represents another strong addition to our Board of Directors and positions us well for continued growth."

    About XPOVIO® (selinexor)

    XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO 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. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm's supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

    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), 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. 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.

    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 the global development and commercialization of XPOVIO. 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; that regulators will agree that selinexor qualifies for conditional approval in the E.U. as a result of data from the STORM study or confirmatory approval in the U.S. or EU based on the BOSTON study in patients with relapsed or refractory 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, 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 in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; 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 obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which was filed with the Securities and Exchange Commission (SEC) on August 4, 2020, 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.

     

    Cision View original content:http://www.prnewswire.com/news-releases/karyopharm-therapeutics-appoints-christy-j-oliger-to-its-board-of-directors-301120714.html

    SOURCE Karyopharm Therapeutics Inc.

    View Full Article Hide Full Article
  5. NEWTON, Mass., Aug. 21, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, congratulates its founder, President and Chief Scientific Officer, Sharon Shacham, PhD, MBA, for being selected as a finalist in the EY Entrepreneur of the Year 2020 New England Awards Program. For more than 30 years, this award has served as one of the world's most prestigious business awards recognizing entrepreneurs who have disrupted industries, created new product categories and successfully brought innovations that have transformed our world. Dr. Shacham was recognized for her scientific research that led to the development and FDA approval of XPOVIO® (selinexor), as well…

    NEWTON, Mass., Aug. 21, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, congratulates its founder, President and Chief Scientific Officer, Sharon Shacham, PhD, MBA, for being selected as a finalist in the EY Entrepreneur of the Year 2020 New England Awards Program. For more than 30 years, this award has served as one of the world's most prestigious business awards recognizing entrepreneurs who have disrupted industries, created new product categories and successfully brought innovations that have transformed our world. Dr. Shacham was recognized for her scientific research that led to the development and FDA approval of XPOVIO® (selinexor), as well as for leading Karyopharm from its inception to what is now a global pharmaceutical company focused on the discovery, development, and commercialization of novel medicines for patients with cancer and other major diseases.

    "Not only is Dr. Shacham a renowned expert in the biologic mechanisms of cancer and a pioneer in advancing important medical innovations, but she is a true business leader who inspires those around her to achieve extraordinary results," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "Under her scientific leadership, we have built a robust research and development organization since our founding in 2008 and have the only nuclear export inhibitor approved in the U.S. This award recognizes the importance of her entrepreneurial spirit and the vital role her leadership and persistence have played in bringing new treatment options to patients battling cancer and other serious diseases."

    Dr. Shacham stated, "It's an honor to be named a finalist for the EY Entrepreneur Of The Year® award and I am thrilled to be recognized among the 2020 class of visionary finalists in New England. As we all face unprecedented challenges in our current environment, I think we need entrepreneurs now, more than ever, to help encourage others and solve society's problems often thought to be insurmountable. I sincerely hope the work we are doing at Karyopharm will not only enable improved clinical outcomes for patients but that we can continue to inspire those around us to set and achieve aspirational goals that will benefit as many people as possible."

    The Entrepreneur Of The Year® is the world's most prestigious business awards program for unstoppable entrepreneurs. These visionary leaders deliver innovation, growth and prosperity that transform our world. The program engages entrepreneurs with insights and experiences that foster growth. It connects them with their peers to strengthen entrepreneurship around the world. For more information please visit https://www.ey.com/en_us/entrepreneur-of-the-year/new-england/overview.

    About Sharon Shacham, PhD, MBA

    Dr. Shacham founded Karyopharm in 2008 and has served as our Chief Scientific Officer and President of Research and Development since December 2012. From 2010 to 2012, Dr. Shacham served as our Chief Scientific Officer and Head of Research and Development, and prior to that, as our President and Chief Executive Officer. Dr. Shacham has led our scientific progress since inception.

    Prior to joining Karyopharm, Dr. Shacham served as Senior Vice President of Drug Development at Epix Pharmaceuticals, Inc., and Director, Algorithm and Software Development at Predix Pharmaceuticals Inc., which merged into Epix Pharmaceuticals in 2006, and where she led the company's efforts in GPCR modeling, computational chemistry, lead optimization and development of clinical trials.

    Dr. Shacham holds a Bachelor of Science in Chemistry, along with a Doctor of Philosophy in Biophysical Chemistry and a Master of Business of Administration from Tel Aviv University.

    About XPOVIO® (selinexor)

    XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO 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. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm's supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

    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), 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. 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.

    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 the global development and commercialization of XPOVIO. 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; that regulators will agree that selinexor qualifies for conditional approval in the E.U. as a result of data from the STORM study or confirmatory approval in the U.S. or EU based on the BOSTON study in patients with relapsed or refractory 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, 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 in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; 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 obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which was filed with the Securities and Exchange Commission (SEC) on August 4, 2020, 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.

    Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited.

    Cision View original content:http://www.prnewswire.com/news-releases/karyopharms-founder-sharon-shacham-phd-selected-as-a-finalist-for-the-ey-entrepreneur-of-the-year-2020-award-301116256.html

    SOURCE Karyopharm Therapeutics Inc.

    View Full Article Hide Full Article
View All Karyopharm Therapeutics Inc. News