BIO News

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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 5.) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) (announced a partnership with Catalent Inc (NYSE: CTLT) for manufacturing of a vaccine against the novel coronavirus) * BIO-TECHNE Corp (NASDAQ: TECH) * Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) * ChemoCentryx Inc (NASDAQ: CCXI) * DexCom, Inc. (NASDAQ: DXCM) (received Health Canada temporary authorization for its Dexcom G6 CGM for use in hospitals to monitor critically ill patients during COVID-19 pandemic) * Halozyme Therapeutics, Inc. (NASDAQ: HALO) (announced FDA approval for Johnson & Johnson (NYSE: JNJ) Janssen unit's subcutaneous formulation of Darzalex, which uses Halozyme's Enhanze technology, in treating multiple myeloma) * Imara Inc (NASDAQ: IMRA) * Immunomedics, Inc. (NASDAQ: IMMU) (announced the commercial availability of its recently-approved breast cancer drug Trodelvy in the U.S.) * Masimo Corporation (NASDAQ: MASI) * Minerva Neurosciences Inc (NASDAQ: NERV) * Vermillion, Inc. (NASDAQ: VRML) * Zynex Inc. (NASDAQ: ZYXI)None of the biotech/medical devices/diagnostics company hit 52-week lows Monday.Stocks In Focus Adverum's Gene Therapy Shows Robust Efficacy, Safety In Phase 1 Study For Wet Age-Related Macular Degeneration Adverum Biotechnologies Inc (NASDAQ: ADVM) announced new interim clinical data from Cohorts 1-3 of the OPTIC Phase 1 dose-ranging clinical study of single-dose of ADVM-022 intravitreal injection gene therapy in patients with wet age-related macular degeneration, which further demonstrated the transformative potential of ADVM-022 to greatly reduce anti-VEGF injection burden in wet AMD."It's impressive to see the long-term durability demonstrated at the higher dose of ADVM-022 in a patient population that previously required frequent injections to maintain their vision and are now beyond one year of follow-up with no rescue injections," Arshad Khanani, the study's principal investigator, said in a statement.The company also offered a business update, reporting cash, cash equivalents and short-term investments of $297 million as of March 31. Adverum said it expects to submit a NDA for ADVM-022 in diabetic retinopathy in the first half of 2020 and present data from all four cohorts of the OPTIC trial in the second half.Bio-Rad Droplet Digital PCR Test Kit For Coronavirus Receives EUA Bio-Rad said its SARS-CoV-2 Droplet Digital PCR test kit has been granted Emergency Use Authorization by the FDA. The SARS-CoV-2 Droplet Digital PCR test runs on Bio-Rad's QX200 and QXDx ddPCR systems.Chembio's Serological Test For Coronavirus Gets CE Marking Chembio Diagnostics Inc (NASDAQ: CEMI) said it has attained the CE Marking for its DPP COVID-19 System. The CE Marking allows the company commercialize the system within the member states of the European Union and the Caribbean region, except for Puerto Rico.The DPP COVID-19 System is a serological test and analyzer that provides numerical readings for both IgM and IgG antibody levels within 15 minutes from a simple finger stick drop of blood. The test has received EUA in the U.S.Separately, the company reported first-quarter results, showing a 20% decline in revenue to $6.9 million and a wider net loss of 29 cents per share.In premarket trading Tuesday, the stock was gaining 17.47% to $14.39.View more earnings on IBBSee also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates Regeneron, Sanofi Say PD-1 Inhibitor Libtayo Found Effective In Skin Cancer In Pivotal Study Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA (NASDAQ: SNY) announced top-line data from a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo in patients with advanced basal cell carcinoma who had progressed on or were intolerant to prior hedgehog pathway inhibitor therapy. The data showed the investigational asset demonstrated clinically meaningful and durable responses in this group of patients for whom there are currently no approved treatments.The companies said they plan regulatory submissions in 2020.Libtayo was approved in September 2018 by the FDA to treat patients with metastatic cutaneous squamous cell carcinoma.Insmed Announces Secondary Offering Of Common Stock Insmed Incorporated (NASDAQ: INSM) 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.The stock was down 0.84% at $24.65 in Tuesday's premarket session.Earnings GenMark Diagnostics, Inc (NASDAQ: GNMK) announced first-quarter revenue of $38.7 million, in line with the number it mentioned in its April 8 pre-announcement and representing an 80% year-over-year increase. The loss per share narrowed from 21 cents to 12 cents, while analysts estimated a loss of 14 cents per share.The company raised its full-year revenue guidance to $120 million to $130 million, ahead of the $108.58-million consensus estimate, and it also increased its gross margin guidance to 38-40%.Separately, GenMark announced the appointment of Scott Mendel as CEO. Mendel has been serving as CEO on an interim basis since February.The stock was up 13.29% at $13.30 in the premarket session.On The Radar Earnings * Oxford Immunotec Global PLC (NASDAQ: OXFD) (before the market open) * Karyopharm Therapeutics Inc (NASDAQ: KPTI) (before the market open) * Haemonetics Corporation (NYSE: HAE) (before the market open) * Antares Pharma Inc (NASDAQ: ATRS) (before the market open) * Harvard Bioscience, Inc. (NASDAQ: HBIO) (before the market open) * Vericel Corp (NASDAQ: VCEL) (before the market open) * Regeneron * Neuronetics Inc (NASDAQ: STIM) (before the market open) * Mallinckrodt PLC (NYSE: MNK) (before the market open) * Akebia Therapeutics Inc (NASDAQ: AKBA) (before the market open) * Agile Therapeutics Inc (NASDAQ: AGRX) (after the market close) * Aquestive Therapeutics Inc (NASDAQ: AQST) (after the market close) * Akcea Therapeutics Inc (NASDAQ: AKCA) (after the market close) * Acorda Therapeutics Inc (NASDAQ: ACOR) (after the market close) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) (after the market close) * Synthetic Biologics Inc (NYSE: SYN) (after the market close) * T2 Biosystems Inc (NASDAQ: TTOO) (after the market close) * Iovance Biotherapeutics Inc (NASDAQ: IOVA) (after the market close) * MacroGenics Inc (NASDAQ: MGNX) (after the market close) * Zogenix, Inc. (NASDAQ: ZGNX) (after the market close) * Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the market close) * Exelixis, Inc. (NASDAQ: EXEL) (after the market close) * Myriad Genetics, Inc. (NASDAQ: MYGN) (after the market close) * Inspire Medical Systems Inc (NYSE: INSP) (after the market close) * Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the market close) * Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (after the market close) * Nevro Corp (NYSE: NVRO) (after the market close) * Clovis Oncology Inc (NASDAQ: CLVS) (after the market close) * InVitae Corp (NYSE: NVTA) (after the market close) * Cytosorbents Corp (NASDAQ: CTSO) (after the market close) * Cardiovascular Systems Inc (NASDAQ: CSII) (after the market close) * Cerus Corporation (NASDAQ: CERS) (after the market close) * Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) (after the market close) * Incyte Corporation (NASDAQ: INCY) (after the market close) * Orthopediatrics Corp (NASDAQ: KIDS) (after the market close)Related Link: The Week Ahead In Biotech: Smid-Cap Earnings News Flow Picks Up Pace See more from Benzinga * The Daily Biotech Pulse: Gilead Slips Despite Forecast-Beating Q1, Moderna Partners With Lonza For Coronavirus Vaccine Production, Lyra Therapeutics IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

In this episode of Yahoo Finance Presents, correspondent Jen Rogers speaks with co-founder of Palantir and founding partner at 8VC Joe Lonsdale about investing during the coronavirus pandemic as well as the technology his companies have been using to help fight the virus.

Bio-Rad Laboratories Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad’s QX200 and QXDx ddPCR systems.

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Bio-Rad (BIO) 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.

Bio-Rad (BIO) delivered earnings and revenue surprises of 36.43% and 4.75%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced financial results for the first quarter ended March 31, 2020.

Each of Bio-Rad's (BIO) key segments registers solid growth across three major geographies of America, Europe and Asia.

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Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the FDA. Bio-Rad’s blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2, the virus associated with COVID-19 disease. The test has also met the CE mark requirements for Europe.

Bio-Rad's (BIO) first-quarter 2020 results reflect strong segmental performance boosted by coronavirus-led increased testing demand.

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Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, will report financial results for the first quarter 2020 on Wednesday, May 6, 2020, following the close of the market. The company will discuss these results in a conference call scheduled for 2 PM Pacific Time (5 PM Eastern Time) that day.

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Ladies and gentlemen, thank you for standing by, and welcome to the Q1 2020 Bio-Rad Laboratories Inc. Earnings Conference Call. With me on the phone are Norman Schwartz, our Chief Executive Officer; Ilan Daskal, Executive Vice President and Chief Financial Officer; Andy Last, Executive Vice President and Chief Operating Officer; Annette Tumolo, President of the Life Science Group; and Dara Wright, President of the Clinical Diagnostics Group.

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To get ready for earnings season, focus on stocks in or near a potential buy range ahead of their next quarterly report. One company that meets that criteria is Bio Rad Labs (BIO). It's expected to release its latest numbers around May 6. It's trading approximately 3% above a 413.12 buy point from a second-stage cup without handle. Understand that...

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Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced the commercial launch of its SARS-CoV-2 Total Ab test, a blood-based immunoassay kit to help determine if an individual has developed antibodies to SARS-CoV-2, the virus associated with COVID-19 disease. Bio-Rad has applied for Emergency Use Authorization offered by the U.S. Food and Drug Administration and has met the CE mark requirements for Europe.

Announcement of Periodic Review: Moody's announces completion of a periodic review of ratings of Bio-Rad Laboratories, Inc. New York, May 15, 2020 -- Moody's Investors Service ("Moody's") has completed a periodic review of the ratings of Bio-Rad Laboratories, Inc. and other ratings that are associated with the same analytical unit. The review was conducted through a portfolio review in which Moody's reassessed the appropriateness of the ratings in the context of the relevant principal methodology(ies), recent developments, and a comparison of the financial and operating profile to similarly rated peers.

May incidentally prove useful in tracking plant development.

Bio-Rad Laboratories Inc. (BIO) has started the commercial launch of its blood-based kit test which is used to screen if patients have developed antibodies against SARS-CoV-2, the virus causing COVID-19.The company, which makes test systems for medical diagnostics products, said that the test can help clinicians detect patients who have been infected by SARS-CoV-2 by checking if they develop an immune reaction to the virus. The test can be done manually or by using automated equipment. Bio-Rad asserts that antibody testing provides a more complete account of infection rates and immunity to help public health officials in their efforts to reduce containment rates.Clinical evaluation of the SARS-CoV-2 antibody test has demonstrated diagnostic specificity of more than 99% and diagnostic sensitivity of 98%, Bio-Rad said. In addition, cross-reactivity testing showed specificity of 100% with no response against other interfering specimens including non-CoV-2 coronaviruses.On an update on regulatory hurdles, Bio-Rad said the company has met the CE mark requirements for Europe and has applied for Emergency Use Authorization status awarded by the U.S. Food and Drug Administration.“Having applied for FDA Emergency Use Authorization and meeting the requirements for CE marking, we have begun shipping the test and are in the process of scaling up manufacturing to meet demand in the weeks and months ahead,”  Dara Wright, Bio-Rad Clinical Diagnostics Group EVP & President said.Bio-Rad shares advanced 0.5% to $426.94 around midday trading on the New York Stock Exchange. Citigroup analyst Patrick B Donnelly yesterday raised the company’s price target to $480 from $425, while maintaining a Buy rating.TipRanks data shows that Donnelly is 1 of 4 Wall Street analysts recommending investors buy the company’s stock adding up to a Strong Buy consensus rating. However, the $450 average price target suggests shares are poised to gain a mere 5.9% in the next 12 months. (See Bio-Rad Laboratories stock analysis on TipRanks).Related News: Pre-Market: Vaxart Pops 35% On Positive Covid-19 Vaccine Data SAP Sees New Software Business Shelved; 1Q Earnings Miss Estimates 3 “Strong Buy” Penny Stocks That Could See Outsized Gains More recent articles from Smarter Analyst: * Apple Shores Up $8.5 Billion in Debt For Dividend Payout, Share Buybacks * Amarin (AMRN): All Eyes on Vascepa Appeal Verdict * Nokia Stock Is a Long-Term Play, Says Top Analyst * $370 Is the Number to Watch for Apple Stock, Says 5-Star Analyst

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