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Zacks.com featured highlights include: Myriad Genetics, Cinemark, Vericel and IDEXX Laboratories
Myriad Genetics, Inc. (MYGN), a global leader in molecular diagnostics and precision medicine, today announced the election of Daniel K. Spiegelman, age 61, to its Board of Directors, effective immediately, expanding the Board to nine members. Additionally, Mr. Spiegelman was appointed to the audit committee of Myriad’s Board. Mr. Spiegelman has served as a Chief Financial Officer in several diversified biotechnology companies spanning 30 years.
Cerecor Inc. (CERC) and Myriad Genetics Inc. (MYGN) today announced that levels of novel cytokine, LIGHT, were highly correlated with disease severity and mortality in a COVID-19 acute respiratory distress syndrome (ARDS) biomarker study. The biomarker study was conducted using the serum samples of 47 hospitalized COVID-19 patients and 30 healthy controls from Hackensack Meridian Health Network.
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 May 19) * ADC Therapeutics SA (NYSE: ADCT) (IPOed May 15) * Allogene Therapeutics Inc (NASDAQ: ALLO) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * BioXcel Therapeutics Inc (NASDAQ: BTAI) * ChemoCentryx Inc (NASDAQ: CCXI) * Evoke Pharma Inc (NASDAQ: EVOK) * I-Mab ADR (NASDAQ: IMAB) * Imara Inc (NASDAQ: IMRA) * Intellia Therapeutics Inc (NASDAQ: NTLA) * Neurocrine Biosciences, Inc. (NASDAQ: NBIX) * Syndax Pharmaceuticals Inc (NASDAQ: SNDX) * Translate Bio Inc (NASDAQ: TBIO) * Twist Bioscience Corp (NASDAQ: TWST) * United Therapeutics Corporation (NASDAQ: UTHR) * VBI Vaccines Inc (NASDAQ: VBIV) * Vermillion, Inc. (NASDAQ: VRML) * Zai Lab Ltd (NASDAQ: ZLAB) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Down In The Dumps (Biotech Stocks Hitting 52-week Lows May 19) * Lyra Therapeutics Inc (NASDAQ: LYRA) (IPOed May 1)Stocks In Focus Myriad Announces FDA Approval For Companion Diagnostic Test For Prostate Cancer Myriad Genetics, Inc. (NASDAQ: MYGN) said the FDA approved the BRACAnalysis CDx test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer who are eligible for treatment with Lynparza.Lynparza is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca plc (NYSE: AZN) and Merck & Co., Inc. (NYSE: MRK).In pre-market trading Wednesday, Myriad shares were advancing 8.21% to $15.68.Aldeyra To Advance Two Pipeline Assets Into Clinical Trials For COVID-19 Treatment Aldeyra Therapeutics Inc (NASDAQ: ALDX) announced the planned advancement of the investigational new HSP90 inhibitor ADX-1612 to clinical testing for COVID-19, and provided an update on ADX-629, a novel investigational RASP inhibitor in development for COVID-19 and other inflammatory diseases.Aldeyra announced that ADX-1612 has demonstrated nanomolar potency similar to or greater than that of remdesivir in an in vitro model. Complementary to the nucleic acid inhibition mechanism of action of remdesivir and related antiviral compounds, ADX-1612 potentially leads to the inhibition of proteins associated with viral replication and infection, and thereby may enhance the activity of other antiviral drugs for the treatment of COVID-19. Pending FDA feedback, the company expects to file an IND the third quarter of 2020.The company said ADX-629 has completed pre-IND discussions with the Pulmonary Division of the FDA, and an IND application is expected to be submitted in June 2020.In pre-market trading, shares were up 23.70% to $4.75.Eiger's NDA For Progeria Drug Accepted For Accelerated Review Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) said the FDA accepted its NDA for an accelerated review of Zokinvy for treatment of Progeria and Progeroid Laminopathies. The PDUFA action date has been fixed for Nov. 20. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss this application.View more earnings on IBBRelated Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan StanleyBio-Techne Announces Pact to Develop and Scale Up Serology Test Kits For Coronavirus BIO-TECHNE Corp (NASDAQ: TECH) and Kantaro Biosciences, the commercial affiliate of the Mount Sinai Health System in New York, announced a partnership to initiate scaled manufacturing and distribution of testing kits based on the Mount Sinai-developed COVID-19 serology test.Bio-Techne said it has partnered with Kantaro to develop a test kit based on the Mount Sinai test and to scale up, manufacture, sell and distribute these kits. Initial kit production capacity is expected to enable laboratories to conduct in excess of 10 million tests monthly in July, scaling to higher capacity in subsequent months..Offerings Ocular Therapeutix Inc (NASDAQ: OCUL) said it has commenced an underwritten public offering of its common stock. All of the shares in the offering are to be sold by the company. The company also said the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.The stock fell 4.65% to $6.15 in after-hours trading.Medigus Ltd. (NASDAQ: MDGS) said it has priced its underwritten public offering of 3.33 million ADSs at a price of $1.50 per ADS. Each pre-funded warrant that allows purchase of one ADS is priced at $1.499 per pre-funded warrant. The company noted that the pre-funded warrants are exercisable at any time after the date of issuance upon payment of the exercise price of $0.001 per ADS.The stock slipped 10.24% to $2.63 in after-hours trading.VolitionRX Ltd (NYSE: VNRX) said it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares are being offered by the company.In after-hours trading, the stock fell 7.30% to $2.92.On The Radar Earnings Mediwound Ltd (NASDAQ: MDWD) (before the market open) China Biologic Products Holdings Inc (NASDAQ: CBPO) (after the close) Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the close)See more from Benzinga * The Daily Biotech Pulse: FDA Nod For Roche, Arbutus Releases Positive Readout For HBV Therapy, Moderna Announces .34B Common Stock Offering * The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Earnings Flow Slows * The Daily Biotech Pulse: Co-Diagnostics Earnings, NantKwest Plans Pancreatic Cancer Study, ADC Therapeutics IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Myriad Genetics, Inc. (MYGN), a leader in molecular diagnostics and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) approved the BRACAnalysis CDx® test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza® (olaparib). Lynparza is approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
The rising incidence of cancer cases has encouraged several major pharmaceutical and biotech players to invest substantially in the developments of drugs.
Myriad Genetics, Inc. (MYGN), a leader in molecular diagnostics and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) approved the myChoice CDx® test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency (HRD) status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab. Lynparza (olaparib) is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca (LSE/STO/NYSE: AZN) and Merck, known as MSD outside of the U.S. and Canada.
Myriad Genetics (MYGN) reports revenue declines in both reporting segments in Q3 resulting from coronavirus-led business disruptions.
Image source: The Motley Fool. Myriad Genetics Inc (NASDAQ: MYGN)Q3 2020 Earnings CallMay 5, 2020, 4:30 p.m. ETContents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: OperatorGreetings, and welcome to the Myriad Genetics Third Quarter 2020 Financial Earnings Call.
Total Third-Quarter Revenues of $164.0 MillionThird-Quarter Diluted EPS of ($1.55) and Adjusted EPS of ($0.08) SALT LAKE CITY, May 05, 2020 -- Myriad Genetics, Inc. (NASDAQ:.
SALT LAKE CITY, April 28, 2020 -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced that it will hold its fiscal.
Myriad (MYGN) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a global leader in molecular diagnostics and precision medicine, today announced the publication of a meta-analysis of four clinical trials demonstrating that the GeneSight® Psychotropic test significantly improves clinical outcomes among patients with major depressive disorder (MDD). “Many commercial insurers and health technology assessors in the United States and internationally consider meta-analyses the highest level of clinical evidence for the treatment of depression,” said Bryan Dechairo, Ph.D., executive vice president of Clinical Development at Myriad. The analysis included data from four prospective, controlled trials that evaluated the clinical utility of the GeneSight test in 1,556 people with MDD and who had at least one prior antidepressant medication failure.
Myriad Genetics, Inc. (MYGN), a global leader in personalized medicine, announced today that due to the impact of the global COVID-19 pandemic, the company is withdrawing its fiscal year 2020 financial guidance. “Prior to mid-March we were experiencing volume trends consistent with our expectations across all products; however, recent social distancing guidelines have had a significant impact on test volume trends in late March and into the fiscal fourth-quarter,” said R. Bryan Riggsbee, interim president and CEO and chief financial officer at Myriad Genetics. In responding to the pandemic, Myriad has made several changes to its business practices to promote the safety of both customers and employees including ceasing in-office sales calls and implementing virtual selling, granting all non-essential personnel the ability to work from home, enabling direct sample collection for patients and implementing policies to improve laboratory personnel safety.
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Myriad Genetics (MYGN) launches BRACAnalysis Diagnostic System in Japan, after receiving reimbursement for the system, which will enable easier identification of HBOC patients.
Myriad Genetics, Inc. (MYGN), a leader in molecular diagnostics and precision medicine, announced that it has received reimbursement and launched the BRACAnalysis® Diagnostic System (i.e., “BRACAnalysis”) in Japan to help physicians determine which people affected with breast and ovarian cancer have Hereditary Breast and Ovarian Cancer (HBOC) syndrome and qualify for additional diagnostic and medical management. BRACAnalysis previously was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in November 2019 for this indication.
Myriad Genetics, Inc. (MYGN), a leader in molecular diagnostics and precision medicine, announced it has submitted a supplementary application with the Japanese Ministry of Health Labour and Welfare for its BRACAnalysis® Diagnostic System (i.e., “BRACAnalysis”) to be used as a companion diagnostic to help to identify people with metastatic pancreatic or metastatic castration-resistant prostate cancer who have germline BRCA1 and BRCA2 mutations and may be candidates for targeted therapy with the PARP inhibitor, Lynparza® (olaparib), subject to regulatory approval. “Today’s regulatory filing potentially will expand the approved indications for BRACAnalsyis as companion diagnostic test in Japan,” said Gary King, executive vice president of International Operations at Myriad.
Myriad Genetics, Inc. (MYGN), a global leader in molecular diagnostics and precision medicine, announced today that S. Louise Phanstiel has been appointed as chair of the Board of Directors. John T. Henderson, M.D., will remain on the Board of Directors.
Myriad Genetics (MYGN) registers soft Hereditary Cancer, GeneSight, Vectra as well as Prenatal revenues in second-quarter fiscal 2020.
Myriad Genetics, Inc. (MYGN), a global leader in molecular diagnostics and precision medicine, announced that the National Comprehensive Cancer Network (NCCN) updated its professional guidelines for prostate cancer to recommend biomarker-based testing for men with unfavorable intermediate and high-risk disease. Myriad’s Prolaris test was one of only two prognostic tests for prostate cancer recommended by NCCN for the new expanded indications and is now broadly recommended for use in low, intermediate and high-risk disease. “NCCN’s endorsement of Prolaris testing in unfavorable intermediate and high-risk disease is a major step forward for men and will help in expanding access to testing,” said Todd D. Cohen, M.D., vice president of Medical Affairs for Urology at Myriad Genetics.