19.26 -0.24 (-1.23%)
After hours: 4:16PM EDT
Commodity Channel Index
|Bid||19.17 x 4000|
|Ask||19.80 x 1000|
|Day's Range||19.25 - 19.53|
|52 Week Range||12.43 - 20.93|
|Beta (5Y Monthly)||1.12|
|PE Ratio (TTM)||24.03|
|Forward Dividend & Yield||0.83 (4.31%)|
|Ex-Dividend Date||Sep 27, 2019|
|1y Target Est||20.90|
Protalix (PLX) announces submission of regulatory application seeking approval for its lead pipeline candidate, pegunigalsidase alfa, for Fabry disease.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that interim analysis data from the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session at the virtual 56th American Society of Clinical Oncology (ASCO) Annual Meeting and the 25th European Hematology Association (EHA) Annual Meeting. The OPTIC trial is an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ICLUSIG® (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced the results of the Phase 2 Pevonedistat-2001 trial will be presented during oral sessions at the virtual 56th American Society of Clinical Oncology (ASCO) Annual Meeting and the virtual 25th European Hematology Association (EHA) Annual Meeting. The study evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including higher-risk myelodysplastic syndromes (HR-MDS). These results show that the combination of pevonedistat and azacitidine is a highly active, promising therapeutic approach and suggest benefit in the HR-MDS subgroup across multiple clinically meaningful endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, with a safety profile similar to azacitidine alone.
Takeda Receives Positive CHMP Opinion for Pre-filled Syringe Presentation of TAKHZYRO® (lanadelumab) for use as a Preventive Treatment for Hereditary
Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) ("Takeda") today announces that on May 28, the European Commission (the "EC") has released Takeda from the obligation to divest the pipeline compound SHP647 and certain associated rights ("SHP647"), a commitment that was provided by Takeda to secure regulatory clearance of its acquisition of Shire plc ("Shire"). Takeda will discontinue the current SHP647 clinical trial program, and it will be providing all eligible trial participants with the opportunity to have continued access to SHP647 in a post-trial access ("PTA") study. In addition, subject to obtaining trial participant consents and the satisfaction of regulatory and ethical considerations, Takeda will make SHP647 clinical trial data and biosamples available to the scientific community through the Crohn’s & Colitis Foundation ("Foundation").
A coalition of world-leading medical and research institutions, blood centers, life science companies, technology companies, philanthropic organizations, and COVID-19 survivor groups has come together to support the rapid development of potential new therapies for patients with COVID-19. Working together under the "The Fight Is In Us" campaign, the coalition is seeking to mobilize tens of thousands of people in the United States who have recovered from COVID-19 to donate their blood plasma, which contains vital antibodies that have fought off the disease and could now help others do the same.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the first-line setting. ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations.
Seattle Genetics (SGEN) secures a nod from the European Commission for Adcetris to treat adult patients with previously untreated systemic anaplastic large cell lymphoma.
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) ("Takeda") today announced that the company will present data from its expanding oncology pipeline and established product portfolio at two upcoming virtual scientific congresses: the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 29-31 and the 25th Virtual Congress of the European Hematology Association (EHA), June 11-14.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that the European Commission (EC) extended the current conditional marketing authorization of ADCETRIS® (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone). Systemic anaplastic large cell lymphoma is a subtype of peripheral T-cell lymphoma (PTCL). The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 27, 2020.
Tokyo shares dropped on Thursday, in line with Wall Street, as the U.S. Federal Reserve chairman's comments about an extended period of weak economic growth offset optimism around the early lifting of Japan's coronavirus-driven state of emergency in some regions. Wall Street's three major indexes fell on Wednesday due to worries about a second wave of COVID-19 infections and Fed Chair Jerome Powell's subdued view on the recovery of an economy battered by the coronavirus pandemic. E-Mini futures for the S&P 500, which were last quoted down 0.5% in late Asian trade, dealt another blow to Tokyo shares.
Japanese stocks fell on Thursday, tracking an overnight slide on Wall Street, as sentiment soured after the U.S. Federal Reserve's chairman warned of an extended period of weak economic growth. Wall Street's three major indexes slid for the second day in a row due to worries about a second wave of coronavirus infections and Fed Chair Jerome Powell's subdued view on the recovery of an economy battered by the coronavirus pandemic. Further fuelling investor worries, a top World Health Organization official said the virus may never go away.
The clinical trial would include hundreds of patients and take several months to complete. If successful, Japan's Takeda could file for approval by U.S. authorities this year, said Julie Kim, president of the plasma-derived therapies unit of Takeda. "When the product will be available beyond the clinical study is still a bit unclear," Kim said on an investor call.
Takeda Pharmaceutical Co booked a surprise operating profit and forecast that income would triple this business year as hefty acquisition costs related to last year's $59 billion Shire takeover recede. Takeda also said it could start clinical trials in July for its plasma-derived therapy for COVID-19, initially called TAK-888, according to plasma division President Julie Kim. Japan's largest drugmaker estimated 355 billion yen ($3.3 billion) in operating profit for the year to March.
Takeda Pharmaceutical Company Limited (TOKYO: 4502) (NYSE: TAK) ("Takeda") today announced financial results for the year ended March 31, 2020 (FY2019). As a top 10 global R&D-driven biopharmaceutical company, Takeda is demonstrating its innovation and values in its response to COVID-19 and in positioning itself for long-term success.
Ladies and gentlemen, thank you for standing by, and welcome to the first-quarter 2020 Codexis earnings conference call. This is Bruce Voss with LHA. Thank you all for participating in today's Codexis call to discuss first-quarter 2020 financial results and recent business progress.
Approval makes Entyvio the only maintenance therapy approved across Europe with both IV and SC formulation options for adult patients with UC or CD
The CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration recently established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19, is rapidly building momentum. Its membership has expanded globally to include 10 plasma companies, and now also includes global organizations from outside the plasma industry who are providing vital support to encourage more people to donate plasma.
Japan's March jobless rate rose to its highest in a year, while job availability slipped to a more than three-year low, official data showed on Tuesday, as the coronavirus outbreak and containment measures caused the nation's job market to ease. While Japan's comparatively low jobless rate is the envy of many nations, rises in the politically sensitive figure could lead to calls for Prime Minister Shinzo Abe's government to do more to stimulate the economy. The seasonally adjusted unemployment rate rose to 2.5%, its highest level since March last year, internal affairs ministry data showed, and matching economists' 2.5% median forecast.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. There are currently no approved therapies designed to treat this specific form of NSCLC. Mobocertinib is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR and human EGFR 2 (HER2) exon 20 insertion mutations.
Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks hitting 52-week highs April 23.) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Chembio Diagnostics Inc (NASDAQ: CEMI) * Cue Biopharma Inc (NASDAQ: CUE) * Eli Lilly And Co (NYSE: LLY) (reported strong Q1 results) * Exelixis, Inc. (NASDAQ: EXEL) * GenMark Diagnostics, Inc (NASDAQ: GNMK) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) * Immunomedics, Inc. (NASDAQ: IMMU) (announced FDA nod for its ADC to treat triple-negative breast cancer) * Incyte Corporation (NASDAQ: INCY) (announced publication of positive data for Jakafi in acute graft-versus-host disease) * Iovance Biotherapeutics Inc (NASDAQ: IOVA) * Johnson & Johnson (NYSE: JNJ) * Novo Nordisk A/S (NYSE: NVO) * OraSure Technologies, Inc. (NASDAQ: OSUR) * Pluristem Therapeutics Inc. (NASDAQ: PSTI) (announced advancement of its placental cells to modulate cytokine storm) * Quidel Corporation (NASDAQ: QDEL) (filed with the FDA EUA for its SARS-CoV-2 virus assay for direct sampling) * Repligen Corporation (NASDAQ: RGEN) * Seattle Genetics, Inc. (NASDAQ: SGEN) * Verastem Inc (NASDAQ: VSTM) * Vermillion, Inc. (NASDAQ: VRML) * Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) * West Pharmaceutical Services Inc. (NYSE: WST) (reacted to its first-quarter results) * Zai Lab Ltd (NASDAQ: ZLAB) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Down In The Dumps (Biotech stocks hitting 52-week lows April 23.) * NanoVibronix Inc (NASDAQ: NAOV)Stocks In Focus GlaxoSmithKline Anti-PD-1 Monoclonal Antibody Shows Efficacy Against Endometrial Cancer In Early Stage Study GlaxoSmithKline plc (NYSE: GSK) released data from an updated analysis of the Phase 1 GARNET study that showed that dostarlimab, an investigational anti-PD-1monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient endometrial cancer who progressed on or after a platinum-based regimen.The patients were administered 500mg of dostarlimab once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression.Lilly, Innovent Announces Acceptance Of Regulatory Filing For Expanded Indication Of Cancer Drug In China Eli Lilly And Co (NYSE: LLY) and Innovent Biologics announced the National Medical Products Administration of China has accepted the sNDA for Tyvyt sintilimab injection in combination with Alimta and platinum as first-line therapy in non-squamous non-small cell lung cancer.Tyvyt was officially approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least two lines of systemic chemotherapy.FDA Approves Sanofi's Meningococcal Vaccine Sanofi SA (NASDAQ: SNY) announced FDA approval for MenQuadfi -- Meningococcal Conjugate Vaccine -- for the prevention of invasive meningococcal disease in persons 2 years and older.The stock was trading 0.76% higher at $48.74 in Friday's premarket session. See also: Some Biogen Analysts Unimpressed By Explanation For Aducanumab Filing DelayPluristem Secures $53.92M To Advance Pipeline Asset For COVID-19 Treatment Pluristem Therapeutics Inc. (NASDAQ: PSTI) said the European Investment Bank has approved 50 million euros ($53.92 million) in non-dilutive financing for supporting its R&D in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19.The funds will be disbursed in three tranches, with the first tranche consisting of 20 million euros, according to the company. In premarket trading Friday, Pluristem shares were climbing 17.28% to $12.15.Earnings Edwards Lifesciences Corp's (NYSE: EW) first-quarter sales rose 14% to $1.1 billion and adjusted EPS climbed 14% to $1.51, ahead of the $1.33-per-share consensus estimate.View more earnings on IBBCiting the impact from the COVID-19 pandemic, the company lowered its 2020 sales guidance from a range of $4.6 billion-$5 billion to $4 billion-$4.5 billion. The adjusted EPS guidance was lowered from $6.15-$6.40 to $4.75-$5.25.The stock was up 6.99% at $236.50 in Friday's premarket session. Merit Medical Systems, Inc. (NASDAQ: MMSI) reported first-quarter worldwide revenue of $243.5 million, up 2.2%, and non-GAAP EPS of 38 cents. Analysts estimated EPS of 26 cents. The company withdrew its 2020 guidance, citing the uncertainty associated with the COVID-19 pandemic.The stock rose 1.88% to $38.57 in after-hours trading.Takeda Divests Non-Core OTC, Prescription Drugs In Europe For Up To $670M Takeda Pharmaceutical Co Ltd (NYSE: TAK) said it has entered into an agreement to divest a portfolio of select non-core OTC and prescription pharmaceutical products sold in Europe and two manufacturing sites located in Denmark and Poland to Danish pharma company Orifarm Group for up to $670 million.Takeda said the portfolio to be divested fetched sales of $230 million in fiscal year 2018, driven by strong sales of cough/cold and vitamin OTC brands as well as prescription products Warfarin and Levaxin.On The Radar IPO Oric pharma, a clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, priced its upsized IPO of 7.5 million shares at $16 per share, the upper end of the previously estimated price range of $14-$16.The company's shares will be listed on the Nasdaq under the ticker symbol "ORIC."Related Link: Moderna Gains More Than 40% This Week: What You Should Know See more from Benzinga * The Daily Biotech Pulse: FDA Nod For Immunomedics, Lilly's Solid Q1 Beat, Predictive Oncology Restructures Debt * The Daily Biotech Pulse: Immunic To Develop COVID Treatment, Gilead Strikes IO Partnership * The Daily Biotech Pulse: Applied DNA Begins Validating COVID-19 Test, Cara's Positive Readout, Novan Explores Strategic Alternatives(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that it has entered into an agreement to divest a portfolio of select non-core over-the-counter (OTC) and prescription pharmaceutical products sold in Europe, and two manufacturing sites located in Denmark and Poland to Orifarm Group ("Orifarm"), a fast-growing Danish pharmaceutical company, for up to approximately $670 million USD subject to customary legal and regulatory closing conditions.