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Exam Number : CFA-Level-II
Exam Name : Chartered Financial Analyst Level II (CFA Level II)
Vendor Name : Financial
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CFA-Level-II test Format | CFA-Level-II Course Contents | CFA-Level-II Course Outline | CFA-Level-II test Syllabus | CFA-Level-II test Objectives


Exam Code : CFA-LEVEL-II
Exam Name : Chartered Financial Analyst Level II
The chartered financial analyst (CFA) professional designation is offered by the CFA Institute—a global association of investment professionals—to people who successfully complete its exam. The test is comprised of a set of three exams that become increasingly difficult and more complex. Each test has a different set of concepts and questions the student must answer. The exams test students on their comprehension, knowledge, and analysis on a series of different syllabus like accounting, economics, ethics, money management, and security analysis.

Exams are typically offered every June at different centers around the world. For the latest updates on test dates, candidates should monitor the CFA website. Candidates are required to meet a minimum score to pass each level. Those who don't pass are provided with information compared to others who didn't pass. They are able to take the test again.

Similar to Level I, Level II also contains multiple choice questions. However, the questions are grouped into mini-cases called item sets. Each item set consists of a case statement followed by four or six multiple choice questions. There are a total of 21 item sets—10 in the morning session and 11 in the afternoon session. Candidates are required to use the information provided within each item set in the case statement to answer the questions.

Anyone who wishes to complete the test must have a bachelor's degree or equivalent education and must have passed the CFA Level I exam. Test takers must also have three years' worth of qualifying work experience prior to taking the exam. Candidates are given six hours to complete the exam. The cost to enroll varies annually—as does the passing score—and depends on when they enroll. test results are usually provided to candidates within 60 days.

For the Level I exam, the course focus is on investment tools, with relatively less focus on asset valuation and portfolio management. For Level II, though, the course focus shifts more toward asset classes, although the investment tools are still weighted rather high. In terms of learning, the Level II test focuses on the application and analysis of concepts learned in Level I.

The curriculum consists of 10 syllabus that are grouped into four areas:
Ethical and Professional Standards
Investment Tools
Asset Classes
Portfolio Management and Wealth Planning
The following table shows the weightings of these syllabus and broad areas for the Level II exam.

Topic Area Level II
Ethical and Professional Standards (total) 10 Investment Tools (total) 30-60
Corporate Finance 5-15
Economics 5-10
Financial Reporting and Analysis 15-25
Quantitative Methods 5-10
Asset Classes (total) 35-75
Alternative Investments 5-15
Derivatives 5-15
Equity Investments 20-30
Fixed Income 5-15
Portfolio Management and Wealth Planning (total) 5-15
Total 100

Ethics and Professional Standards
This section covers the code of ethics, professional standards and the global investment performance standards. Ethics is one section that is equally important in all of the three levels. The questions will be aimed at the application of the seven standards in professional situations. Other important syllabus are the soft dollars and Research Objectivity Standards (ROS).

Quantitative Methods
You can expect about one to two item sets from the quantitative section. The case statement will most likely present data regression, and ask you to analyze and interpret the data. You may even be asked to calculate some key metrics based on the data provided.

Economics
Similar to the course above, economics is also a small section in Level II. You can expect one item set for this topic. You need to have a good conceptual knowledge of economics, as many of these concepts can be tested along with other topics. One important concept is foreign exchange, and you are likely to be tested on the application of its concepts.

Financial Reporting and Analysis
Financial reporting and analysis represent a large portion of the exam. You can expect about four to five item sets from this section. The important concepts are accounting for inventories, accounting for long-lived assets, accounting for leases, inter-corporate investments, accounting for acquisitions, variable interest entities (VIEs), and financial reporting quality.

You are more likely to be asked item set questions based on a combination of these concepts. You need to learn the processes and principles and practice their application thoroughly. Understanding the nuances and differences in IFRS and U.S. GAAP is critical.

Corporate Finance
Corporate finance is an important but easy-to-handle subject. The concepts in corporate finance are linked with the financial reporting and equity sections. So, the questions may be combined with material from the other sections. The key concepts include capital budgeting, capital structure, dividend and repurchase policy issues, corporate governance, and mergers and acquisitions.

Portfolio Management
You can expect one or two item set questions from portfolio management. The material in this section is huge, and it may be wise to keep this section for the end. Remember that the portfolio management material will get deeper in the Level III exam, so it's a good idea to have a general understanding of concepts here. You will be tested on portfolio theory, market efficiency, and asset pricing concepts.

Equity Investments
Equities is an important section for financial analysts and you can expect about four to five item set questions from equities. There is a lot of material on equity analysis and valuation methods. Note that the equity section is heavy on formulas and you may be asked to perform formula-based calculations and interpretations.

Fixed Income
Fixed income is a small, yet important part of the test that is quite similar to the corporate finance section. Given the accurate financial crisis, this section has become even more important. You can expect one or two item sets on this topic. Like equity investments, fixed income is also heavy on formulas and some of the concepts are quite complex. Key concepts include credit analysis, term structure, bonds, mortgage-backed securities (MBSs), and their valuation.

Derivatives
This is a more challenging section and you can expect at least two item set questions from derivatives. The material covers futures and forwards, options, and swaps. Within derivatives, you should be familiar with currency forwards, interest rate futures and forward rate agreements. In options, you need to understand the options strategies and the models for pricing option contracts. In swaps, you should be able to interpret a swap transaction and figure out the cash flows to the parties involved.

Alternative Investments
This section covers asset classes other than equity and fixed income. The three asset classes, which are a part of the CFA curriculum, are real estate, hedge funds, and private equity. There will be one or two item sets questions from this section. This is a relatively easy section and can help you get that additional score without getting into complex stuff.



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Financial II) Study Guide

Karyopharm reviews First Quarter 2021 monetary outcomes and Highlights fresh enterprise progress | CFA-Level-II cheat sheet and Free test PDF

NEWTON, Mass., might also 3, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a business-stage pharmaceutical business pioneering novel melanoma treatment options, these days mentioned economic effects for the quarter ended March 31, 2021. moreover, Karyopharm highlighted opt for company milestones, together with particulars regarding the appointment of its next President and Chief government Officer, the continuing U.S. commercialization of XPOVIO, and regulatory development in Europe, and provided a top level view of its key medical building programs.

"we are inspired to see patient demand for XPOVIO return to growth in the first quarter of 2021, and they continue to be assured in its long-time period business talents and their potential to extra enhance utilization and expand into further melanoma signs," said Richard Paulson, MBA, a member of the Board of administrators and the newly appointed President and Chief govt Officer of Karyopharm. "as the company is now at a pivotal point in its commercialization efforts, i'm excited to lead Karyopharm in its subsequent chapter as they seek to expand XPOVIO's have an impact on across indications and geographies. searching forward to the remainder of the yr, they are expecting to file desirable-line facts from the part 3 SIENDO look at in endometrial cancer before the end of the year, and they count on receiving a call from the ecu fee regarding their request for a variety of the at present approved indication for NEXPOVIO in Europe in the fourth quarter of 2021."

Mr. Paulson went on to claim, "On behalf of the total Board of directors, I cannot thank Dr. Kauffman sufficient for his imaginative and prescient, leadership, and sizeable contributions to the scientific and initial industrial success executed with the aid of Karyopharm. I look ahead to their growth and endured partnership on behalf of the sufferers they purpose to serve, and the aid of all of their employees, partners, and shareholders who share in their commitment to enhance the lives of sufferers fighting melanoma."

First Quarter 2021 and up to date Highlights

President and CEO Transition

  • Richard Paulson Named subsequent President and CEO of Karyopharm. In may 2021, Karyopharm introduced that Richard Paulson, MBA will prevail Michael G. Kauffman, MD, PhD as Chief government Officer and Sharon Shacham, PhD, MBA, as President, positive might also 3, 2021. Mr. Paulson will also remain a member of the Board of directors. Mr. Paulson, who most these days served as government vice chairman of Ipsen prescription drugs, Inc. and Chief govt Officer of Ipsen North the united states, a world biopharmaceutical company concentrated on innovation and distinctiveness care, has been a member of Karyopharm's Board of administrators because February 2020 and brings over 25 years of world biopharmaceutical trade journey, including a variety of international management roles remodeling companies and constructing tremendously successful groups throughout three continents, the place he has launched most beneficial-in-classification items across multiple therapeutic areas together with oncology drug treatments.

    Dr. Kauffman will proceed to advance the enterprise's mission and continue to be a member of Karyopharm's Board of directors. furthermore, he'll also take on a new function as Senior clinical advisor. during this capability, he'll support book the scientific construction for Karyopharm's mighty pipeline of classes, with a spotlight on strong tumor signs. Dr. Shacham will continue in her position as Chief Scientific Officer, overseeing research, building and regulatory affairs.

  • XPOVIO in Hematologic Malignancies

  • XPOVIO U.S. Commercialization. XPOVIO is approved in the U.S. for 3 signs; i) in mixture with Velcade® (bortezomib) and dexamethasone for the medicine of patients with distinct myeloma after at least one prior therapy; ii) in mixture with dexamethasone for the medication of sufferers with closely pretreated distinctive myeloma; and iii) as a monotherapy for the medication of patients with relapsed or refractory diffuse giant B-cell lymphoma.

    all over the first quarter of 2021, XPOVIO generated net product revenue of $21.7 million, representing a 7% boost as in comparison to the fourth quarter of 2020 and a 35% boost as compared to the first quarter of 2020. net sales for the first quarter of 2021 were mostly driven via prescription demand from both educational and neighborhood-based mostly oncologists for sufferers with dissimilar myeloma. about 1,170 XPOVIO prescriptions were crammed in the first quarter of 2021 as compared to approximately 1,000 prescriptions in the fourth quarter of 2020, representing a 17% enhance in patient demand from the prior quarter. extra, over one hundred sixty new health care professional prescribing accounts were added within the first quarter of 2021, which included physicians treating each myeloma and diffuse large B-telephone lymphoma (DLBCL). additionally, prescription demand in the first quarter of 2021 become the highest generated given that XPOVIO's initial accelerated FDA approval in July 2019.

  • European fee (EC) supplies Conditional advertising Authorization for NEXPOVIO to deal with Penta-Refractory multiple Myeloma. In March 2021, the EC granted conditional advertising authorization for NEXPOVIO in mixture with dexamethasone for the medicine of numerous myeloma in grownup patients who've got as a minimum 4 prior remedies and whose sickness is refractory to at the least two proteasome inhibitors, two immunomodulatory brokers, and an anti-CD38 monoclonal antibody, and who have confirmed ailment development on the last remedy. under the provisions of conditional marketing authorization with the aid of the EC, persisted authorization for this indication is contingent upon verification and outline of medical advantage in a confirmatory trial and is subject to additional monitoring. An EC advertising and marketing authorization during the centralized procedure is valid in all 27 European Union member international locations, as neatly as the European economic enviornment nations of Iceland, Liechtenstein and Norway.
  • European drugs agency (EMA) Validates type II model advertising Authorization utility. In April 2021, the EMA validated Karyopharm's classification II version advertising Authorization software for NEXPOVIO in mixture with Velcade® and dexamethasone for the medication of grownup patients with numerous myeloma. covered in the software are the superb consequences from the pivotal phase three BOSTON look at, which evaluated as soon as-weekly NEXPOVIO in combination with once-weekly Velcade® and low-dose dexamethasone (SVd) in comparison to normal twice-weekly Velcade plus low-dose dexamethasone (Vd) in patients with dissimilar myeloma who've obtained one to 3 prior strains of remedy. This new application is being reviewed by the Committee for Medicinal items for Human Use (CHMP), as a way to issue an opinion to the european fee regarding the skills approval for this extended indication. Karyopharm expects this overview to be achieved in the fourth quarter of 2021.
  • First patient Dosed in phase 2/3 Confirmatory analyze in DLBCL. In February 2021, the primary patient changed into dosed in the section 2/three XPORT-DLBCL-030 analyze of XPOVIO in patients with DLBCL. As a part of XPOVIO's accelerated approval in DLBCL, XPORT-DLBCL-030 analyze will serve because the confirmatory examine for this indication. This examine will investigate the effect of XPOVIO or placebo delivered to a standard backbone immunochemotherapy of rituximab gemcitabine-dexamethasone-platinum (R-GDP) in sufferers who have had one to three prior cures for DLBCL.
  • New scientific statistics to be offered at 2021 American Society of scientific Oncology (ASCO) Annual meeting. nine abstracts highlighting facts from hematologic malignancy reviews could be introduced on the upcoming 2021 ASCO Annual assembly taking area June four-eight, 2021.
  • continued development towards the international expansion of XPOVIO. In February 2021, the Israeli Ministry of fitness, Israel's regulatory agency liable for the approval of latest medicines, issued a principal approval letter for XPOVIO as a remedy for sufferers with either multiple myeloma or diffuse colossal B-cell lymphoma.
  • XPOVIO in building for strong Tumors

  • part three SIENDO look at on the right track to record accurate-Line facts in 2021. The SIENDO examine is an ongoing multicenter, blinded, placebo-managed, randomized section 3 analyze evaluating the efficacy and protection for front-line preservation therapy with XPOVIO in sufferers with advanced or recurrent endometrial cancer. contributors with fundamental stage IV or recurrent disorder who had a partial or complete response after a single line of at least 12 weeks of ordinary taxane-platinum aggregate chemotherapy are randomized in a 2:1 method to receive both protection therapy of 80mg of XPOVIO taken once per week or placebo, unless disorder progression. properly-line statistics from the SIENDO look at is anticipated in the fourth quarter of 2021.
  • New records From section three SEAL analyze published in Future Oncology. In April 2021, new health-related high-quality of lifestyles (HRQoL) data from the SEAL look at, which evaluated XPOVIO in superior unresectable dedifferentiated liposarcoma, have been posted on-line in Future Oncology. The facts established that remedy with selinexor confirmed a few clinical merits in comparison to placebo, including discount in ache, longer time to marked medical deterioration of ache and longer median time to next treatment.
  • New scientific facts to be introduced at 2021 ASCO Annual meeting. Seven abstracts highlighting data from strong tumor studies might be introduced on the upcoming 2021 ASCO Annual meeting taking area June four-eight, 2021. These statistics will include XPOVIO reports in superior colorectal cancer, endometrial cancer, and dedifferentiated liposarcoma.
  • First Quarter 2021 fiscal outcomes       

    web product earnings: internet product salary for the primary quarter of 2021 become $21.7 million, compared to $sixteen.1 million for the first quarter of 2020.

    License and other profits: License and different income for the primary quarter of 2021 was $1.5 million, compared to $2.1 million for the primary quarter of 2020.

    can charge of revenue: can charge of earnings for the first quarter of 2021 were $0.9 million, in comparison to $0.8 million for the primary quarter of 2020. charge of revenue reflects the charges of XPOVIO units bought and third-party royalties on internet product income.

    research and construction (R&D) charges: R&D costs for the primary quarter of 2021 had been $37.1 million, in comparison to $34.0 million for the first quarter of 2020. The increase in R&D charges within the first quarter of 2021 compared to the first quarter of 2020 was basically brought on by persevered scientific trial activity and medical development of selinexor in Karyopharm's lead indications.

    promoting, normal and administrative (SG&A) expenses:  SG&A expenses for the first quarter of 2021 have been $37.7 million, compared to $30.7 million for the first quarter of 2020. The enhance in SG&A fees compared to the first quarter of 2020 turned into due basically to actions to aid the U.S. commercialization of XPOVIO, including the launch of XPOVIO in combination with once-weekly Velcade® and dexamethasone for the treatment of grownup patients with dissimilar myeloma who have acquired as a minimum one prior remedy.

    hobby rate: pastime price for the primary quarter of 2021 turned into $5.1 million, compared to $6.5 million for the first quarter of 2020. The lower in interest cost turned into basically attributable to the lower in non-money hobby cost concerning their 3.00% senior convertible notes due 2025, on account of the adoption of ASU No. 2020-06, Debt—Debt with Conversion and other options and Derivatives and Hedging—Contracts in Entity's own fairness, on January 1, 2021. submit adoption, they are not any longer required to amortize the debt discount to non-cash pastime fee, as that element of $50.6 million has now been reclassified out of equity into the convertible senior notes line on their balance Sheet.

    web loss: Karyopharm stated a net loss of $57.4 million, or $0.seventy seven per share, for the primary quarter of 2021, in comparison to a net loss of $fifty two.9 million, or $0.seventy eight per share, for the first quarter of 2020. internet loss protected non-cash inventory-based compensation rate of $7.4 million and $5.2 million for the primary quarters of 2021 and 2020, respectively.

    money position: cash, cash equivalents, restricted money and investments as of March 31, 2021 totaled $233.6 million, compared to $276.7 million as of December 31, 2020.

    2021 economic Outlook

    in line with its existing working plans, Karyopharm expects its non-GAAP R&D and SG&A costs, aside from inventory-primarily based compensation price, for the full-year 2021 to be within the range of $[280] to $[300] million. Karyopharm has not reconciled the whole yr 2021 outlook for non-GAAP R&D and SG&A expenses to full yr 2021 outlook for GAAP R&D and SG&A expenses because Karyopharm can't reliably predict devoid of unreasonable efforts the timing or volume of the elements that greatly make contributions to the projection of inventory compensation expense, which is excluded from the full year 2021 outlook for non-GAAP R&D and SG&A costs.

    The business expects that its present money, cash equivalents and investments, and the earnings it expects to generate from XPOVIO product earnings, in addition to salary generated from its license agreements, might be satisfactory to fund its planned operations into late 2022.

    Non-GAAP economic information

    Karyopharm makes use of a non-GAAP monetary measure, together with R&D and SG&A charges, to supply working cost counsel. Non-GAAP R&D and SG&A charges exclude inventory-based mostly compensation price. Karyopharm believes this non-GAAP fiscal measure is valuable to traders since it gives greater transparency concerning Karyopharm's working performance as it excludes non-cash stock compensation rate. This non-GAAP economic measure should not be considered a change or a substitute for GAAP R&D and SG&A expenses and will not be considered a measure of Karyopharm's liquidity. as a substitute, non-GAAP R&D and SG&A expenses should most effective be used to supplement an figuring out of Karyopharm's working outcomes as suggested under GAAP.

    conference name assistance

    Karyopharm will host a conference name these days, Monday, might also 3, 2021, at 8:30 a.m. japanese Time, to focus on the primary quarter 2021 economic results, fresh accomplishments, scientific tendencies and company plans. To entry the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes ahead of the birth time and ask to be joined into the Karyopharm Therapeutics call. A reside audio webcast of the name can be accessible beneath "movements & displays" in the Investor component to the business's site, http://investors.karyopharm.com/routine-shows. An archived webcast can be available on the enterprise's site about two hours after the adventure.

    About XPOVIO® (selinexor)

    XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by using selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, increase regulatory and anti-inflammatory proteins, resulting in accumulation of those proteins in the nucleus and adorning their anti-melanoma pastime in the phone. The pressured nuclear retention of these proteins can counteract a large number of the oncogenic pathways that, unchecked, permit melanoma cells with extreme DNA harm to proceed to grow and divide in an unrestrained fashion. Karyopharm bought accelerated U.S. food and Drug Administration (FDA) approval of XPOVIO in July 2019 in mixture with dexamethasone for the medicine of grownup patients with relapsed refractory varied myeloma (RRMM) who have obtained at the least 4 prior remedies and whose sickness is refractory to as a minimum two proteasome inhibitors, at least two immunomodulatory brokers, and an anti-CD38 monoclonal antibody. NEXPOVIO® (selinexor) has also been granted conditional advertising and marketing authorization for adult sufferers with heavily pretreated dissimilar myeloma by way of the european fee. Karyopharm's supplemental New Drug utility (sNDA) inquiring for a diffusion of its indication to include the medication for patients with dissimilar myeloma after at least one prior therapy became permitted via the FDA on December 18, 2020. In June 2020, Karyopharm obtained accelerated FDA approval of XPOVIO for its 2d indication in adult sufferers with relapsed or refractory diffuse tremendous B-phone lymphoma (DLBCL), not in any other case special, together with DLBCL coming up from follicular lymphoma, after at the least 2 lines of systemic remedy. Selinexor is additionally being evaluated in a couple of different mid-and later-phase medical trials throughout diverse melanoma signals, together with as a possible backbone remedy in combination with accredited myeloma remedies (STOMP) and in endometrial melanoma (SIENDO), amongst others. extra section 1, part 2 and part three stories are ongoing or at present planned, including distinct stories in mixture with approved therapies in numerous tumor varieties to further inform Karyopharm's clinical construction priorities for selinexor. additional clinical trial tips for selinexor is purchasable at www.clinicaltrials.gov.

    For more guidance about Karyopharm's items or clinical trials, please contact the scientific suggestions department at:

    Tel: +1 (888) 209-9326 electronic mail: [email protected]

    XPOVIO® (selinexor) is a prescription drugs permitted:

  • In mixture with bortezomib and dexamethasone for the medicine of adult sufferers with distinctive myeloma who have bought at least one prior therapy (XVd).
  • In aggregate with dexamethasone for the treatment of adult patients with relapsed or refractory distinctive myeloma who have obtained at the least 4 prior healing procedures and whose disorder is refractory to as a minimum two proteasome inhibitors, at least two immunomodulatory agents, and an anti–CD38 monoclonal antibody (Xd).
  • For the medication of adult sufferers with relapsed or refractory diffuse large B–phone lymphoma (DLBCL), now not otherwise specified, together with DLBCL arising from follicular lymphoma, after at least 2 traces of systemic remedy. This indication is authorised beneath accelerated approval in line with response expense. endured acclaim for this indication may be contingent upon verification and description of medical improvement in confirmatory trial(s).
  • opt for essential protection guidance

    Warnings and Precautions

  • Thrombocytopenia: display screen platelet counts all through medication. manage with dose interruption and/or reduction and supportive care.
  • Neutropenia: display screen neutrophil counts all through medicine. manipulate with dose interruption and/or discount and granulocyte colony–stimulating factors.
  • Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight reduction might also take place. supply antiemetic prophylaxis. manipulate with dose interruption and/or reduction, antiemetics, and supportive care.
  • Hyponatremia: computer screen serum sodium stages all through remedy. correct for concurrent hyperglycemia and high serum paraprotein degrees. manage with dose interruption, discount, or discontinuation, and supportive care.
  • critical infection: display screen for an infection and treat right now.
  • Neurological Toxicity: recommend sufferers to chorus from driving and undertaking hazardous occupations or actions unless neurological toxicity resolves. Optimize hydration fame and concomitant medications to evade dizziness or mental status changes.
  • Embryo–Fetal Toxicity: may cause fetal hurt. propose adult females of reproductive abilities and men with a feminine companion of reproductive skills, of the potential possibility to a fetus and use of valuable contraception.
  • Cataract: Cataracts may also boost or progress. medication of cataracts constantly requires surgical elimination of the cataract.
  • hostile Reactions

  • probably the most commonplace adversarial reactions (≥20%) in sufferers with varied myeloma who receive XVd are fatigue, nausea, diminished appetite, diarrhea, peripheral neuropathy, higher respiratory tract infection, lowered weight, cataract and vomiting. Grade three–4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. within the BOSTON trial, fatal opposed reactions befell in 6% of patients inside 30 days of remaining remedy. critical antagonistic reactions took place in fifty two% of sufferers. treatment discontinuation cost due to adverse reactions become 19%.
  • the most regular hostile reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, lowered urge for food, reduced weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and higher respiratory tract infection. in the STORM trial, fatal opposed reactions came about in 9% of sufferers. serious opposed reactions came about in fifty eight% of patients. medication discontinuation price because of hostile reactions became 27%.
  • essentially the most typical adverse reactions (incidence ≥20%) in sufferers with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite lessen, weight decrease, constipation, vomiting, and pyrexia. Grade three–4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. in the SADAL trial, fatal hostile reactions happened in 3.7% of patients within 30 days, and 5% of patients within 60 days of final medicine; the most generic deadly antagonistic reactions was an infection (4.5% of patients). critical antagonistic reactions came about in 46% of patients; essentially the most frequent serious adverse response turned into an infection(21% of patients). Discontinuation as a result of antagonistic reactions came about in 17% of patients.
  • Use In selected PopulationsLactation: advise not to breastfeed.

    For additional product information, together with full prescribing assistance, please discuss with www.XPOVIO.com.

    To record SUSPECTED adverse REACTIONS, contact Karyopharm Therapeutics Inc. at 1–888–209–9326 or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch. 

    About Karyopharm Therapeutics

    Karyopharm Therapeutics Inc. (NASDAQ: KPTI) is a commercial-stage pharmaceutical enterprise pioneering novel cancer healing procedures and dedicated to the discovery, construction, and commercialization of first-in-class medication directed towards nuclear export for the treatment of cancer and different ailments. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds characteristic through binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), is accepted within the U.S. in assorted hematologic malignancy indications, including in aggregate with Velcade® (bortezomib) and dexamethasone for the treatment of grownup patients with dissimilar myeloma after at least one prior remedy, in mixture with dexamethasone for the medicine of grownup patients with heavily pretreated varied myeloma and as a monotherapy for the treatment of grownup sufferers with relapsed or refractory diffuse gigantic B-mobile lymphoma. NEXPOVIO® (selinexor) has additionally been granted conditional advertising and marketing authorization in mixture with dexamethasone for adult patients with closely pretreated distinct myeloma with the aid of the ecu commission. besides single-agent and combination pastime towards lots of human cancers, SINE compounds have additionally proven organic undertaking in fashions of neurodegeneration, irritation, autoimmune ailment, definite viruses and wound-healing. Karyopharm has a number of investigational courses in medical or preclinical building. For more counsel, please consult with www.karyopharm.com.

    ahead-looking Statements

    This press unlock includes ahead-looking statements within the which means of The deepest Securities Litigation Reform Act of 1995. Such forward-looking statements include these involving Karyopharm's information on its 2021 non-GAAP analysis and construction and selling, usual and administrative fees; expectations and plans relating to XPOVIO for the treatment of adult patients with relapsed or refractory multiple myeloma or relapsed or refractory diffuse large B-phone lymphoma; commercialization of XPOVIO or any of its drug candidates and the business performance of XPOVIO; submissions to, and the evaluation and talents approval of selinexor by way of, regulatory authorities, including the business's regulatory strategy, the anticipated availability of facts to aid such submissions, timing of such submissions and actions with the aid of regulatory authorities and the potential availability of accelerated approval pathways; the anticipated design of the enterprise's scientific trials; and the therapeutic abilities of and talents clinical construction plans for Karyopharm's drug candidates, particularly selinexor. Such statements are discipline to numerous crucial components, risks and uncertainties, lots of which can be past Karyopharm's handle, that can cause precise movements or consequences to vary materially from Karyopharm's present expectations. as an example, there will also be no make sure that Karyopharm will efficiently commercialize XPOVIO; that regulators will supply confirmatory approval in the European Union in keeping with the BOSTON examine in grownup patients with distinct myeloma; or that any of Karyopharm's drug candidates, together with selinexor, will successfully comprehensive essential clinical building phases or that building of any of Karyopharm's drug candidates will proceed. extra, there will also be no make sure that any nice trends within the construction or commercialization of Karyopharm's drug candidate portfolio will result in stock expense appreciation. management's expectations and, for this reason, any forward-looking statements during this press free up may also be affected by hazards and uncertainties concerning a number of different elements, together with right here: the chance that the COVID-19 pandemic might disrupt Karyopharm's enterprise greater severely than it presently anticipates, together with by using negatively impacting earnings of XPOVIO, interrupting or delaying research and construction efforts, impacting the capability to acquire ample provide for the construction and commercialization of selinexor or different product candidates, delaying ongoing or planned medical trials, impeding the execution of business plans, deliberate regulatory milestones and timelines, or inconveniencing sufferers; the adoption of XPOVIO within the commercial market, the timing and costs concerned in commercializing XPOVIO or any of Karyopharm's drug candidates that obtain regulatory approval; the ability to attain and retain regulatory approval of XPOVIO or any of Karyopharm's drug candidates that receive regulatory approval; Karyopharm's effects of scientific trials and preclinical reviews, together with subsequent analysis of present information and new statistics acquired from ongoing and future reports; the content material and timing of selections made by using the U.S. meals and Drug Administration and other regulatory authorities, investigational overview boards at medical trial websites and publication assessment bodies, including with appreciate to the want for further medical reports; the potential of Karyopharm or its third celebration collaborators or successors in hobby to entirely operate their respective responsibilities below the relevant settlement and the potential future fiscal implications of such agreement; Karyopharm's ability to enroll sufferers in its clinical trials; unplanned cash necessities and expenses; building or regulatory approval of drug candidates by Karyopharm's opponents for products or product candidates during which Karyopharm is at present commercializing or establishing; and Karyopharm's capability to gain, maintain and enforce patent and other highbrow property coverage for any of its products or product candidates. These and other hazards are described beneath the caption "chance factors" in Karyopharm's Annual report on form 10-k for the yr ended December 31, 2020, which was filed with the Securities and change commission (SEC) on February 24, 2021, and in different filings that Karyopharm may additionally make with the SEC in the future. Any ahead-searching statements contained in this press unencumber talk most effective as of the date hereof, and, apart from as required with the aid of legislation, Karyopharm expressly disclaims any duty to update any forward-looking statements, whether because of new counsel, future activities or otherwise.

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

    KARYOPHARM THERAPEUTICS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in lots, except per share quantities)

    Three Months Ended

    March 31,

    2021

    2020

    Revenues:

    Product earnings, internet

    $

    21,731

    $

    16,061

    License and different earnings

    1,529

    2,077

    total revenues

    23,260

    18,138

    working charges:

    cost of revenue

    933

    819

    analysis and building

    37,050

    33,997

    promoting, popular and administrative

    37,650

    30,678

    total operating costs

    75,633

    sixty five,494

    Loss from operations

    (52,373)

    (47,356)

    different revenue (expense):

    pastime salary

    264

    975

    activity price

    (5,095)

    (6,509)

    different (rate) profits, internet

    (sixty one)

    25

    total other cost, internet

    (four,892)

    (5,509)

    Loss earlier than revenue taxes

    (fifty seven,265)

    (fifty two,865)

    revenue tax provision

    (149)

    (66)

    internet loss

    $

    (57,414)

    $

    (52,931)

    net loss per share—fundamental and diluted

    $

    (0.seventy seven)

    $

    (0.78)

    Weighted-commonplace variety of usual shares excellent used in netloss per share—simple and diluted

    seventy four,517

    sixty seven,627

    KARYOPHARM THERAPEUTICS INC. CONDENSED CONSOLIDATED balance SHEETS (unaudited) (in lots)

    March 31,

    2021

    December 31,

    2020

    assets

    cash, cash equivalents and investments

    $

    232,041

    $

    273,455

    limited cash

    1,533

    three,203

    debts receivable

    17,843

    12,881

    other belongings

    23,492

    23,511

    complete belongings

    $

    274,909

    $

    313,050

    Liabilities and stockholders' (deficit) equity

    Deferred earnings

    $

    —

    $

    297

    Convertible senior notes

    168,704

    117,928

    Deferred royalty obligation

    seventy three,088

    73,088

    other liabilities

    72,757

    71,191

    total liabilities

    314,549

    262,504

    complete stockholders' (deficit) fairness

    (39,640)

    50,546

    complete liabilities and stockholders' (deficit) fairness; 75,062 and seventy three,923 shares issued and astonishing at March 31, 2021 and December 31, 2020, respectively

    $

    274,909

    $

    313,050

    supply Karyopharm Therapeutics Inc.

    connected hyperlinks

    http://www.karyopharm.com


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