Hologic Granted FDA Emergency Use Authorization for Its Second Molecular Test for COVID-19

Hologic (HOLX) expects to boost testing capacity by combining its manufacturing ability for the latest EUA of test with its largest installed base of high-throughput molecular instruments.

HOLX earnings call for the period ending March 31, 2020.

Hologic to Webcast Presentations at Upcoming Investor Conferences

HOLX vs. ABMD: Which Stock Is the Better Value Option?

Sorrento Therapeutics claimed Friday its experimental coronavirus treatment is a cure for Covid-19. Hologic stock advanced after it gained authorization for a second coronavirus test.

Q2 2020 Hologic Inc Earnings Call

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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 April 29)• Arvinas Inc (NASDAQ: ARVN) • Biondvax Pharmaceuticals Ltd - ADR (NASDAQ: BVXV) • Bio-Rad Laboratories, Inc. Class A Common Stock(NYSE: BIO) • Capricor Therapeutics Inc (NASDAQ: CAPR)( reacted to data that showed a 100% survival rate in COVID-19 patients treated with its CAP-1002 cell therapy) • Cue Biopharma Inc (NASDAQ: CUE) • DexCom, Inc. (NASDAQ: DXCM)(reacted to its quarterly results) • Erytech Pharma SA (NASDAQ: ERYP)(announced Fast Track Designation from the FDA for its cancer drug in pancreatic cancer) • GenMark Diagnostics, Inc (NASDAQ: GNMK) • I-Mab ADR (NASDAQ: IMAB) • Immunomedics, Inc. (NASDAQ: IMMU) • Keros Therapeutics Inc (NASDAQ: KROS) • Masimo Corporation (NASDAQ: MASI)(announced solid first-quarter results) • Mersana Therapeutics Inc (NASDAQ: MRSN) • Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL) • Zynex Inc. (NASDAQ: ZYXI)(announced its first-quarter results)None of the Nasdaq- or NYSE-listed biotech/medical device/diagnostics company hit 52-week lows Wednesday.Stocks In Focus Marker's Leukemia Drug Candidate Gets Orphan Drug Designation Marker Therapeutics, Inc. (NASDAQ: MRKR) said the FDA accorded Orphan Drug Designation to MT-401, its multi-tumor-associated antigen-specific T cell product for the treatment of patients with acute myeloid leukemia following allogenic stem cell transplant.In after-hours trading, the stock rallied 23.79% to $2.81.Evotec Unit to Work With Ology to Develop Antibodies Against Coronavirus German biopharma Evotec SE (OTC: EVOTF) said its Seattle-based subsidiary Just-Evotec Biologics has entered into a partnership with Ology Bioservices for the evaluation and analytical characterisation of antibodies against SARS-CoV-2 - the virus that causes COVID-19.The company noted this work was based on a contract awarded to Ology by the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies to develop, and manufacture monoclonal antibodies for the treatment and prevention of infections with SARS-CoV-2FDA Approves an Expanded Indication For GlaxoSmithKline's Ovarian Cancer Drug GlaxoSmithKline plc (NYSE: GSK) announced FDA approval for its sNDA for Zejula as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker statusThe stock was up 1.51% to $42.48 in pre-market trading.PDS Biotech Announces Expansion to Cancer Drug Collaboration With NCI PDS Biotechnology Corp (NASDAQ: PDSB) announced an expansion of its previously announced Cooperative Research and Development Agreement with the National Cancer Institute to include studies of PDS0103, a Versamune-based product incorporating novel mucin-1 epitopes developed by the NCI.NCI is already evaluating PDS0101 in combination with two separate immune-modulating agents - NHS-IL12 and M7824 - in a phase 2 clinical trial in advanced HPV-associated cancers.The stock was adding 2.61% to 97 cents in pre-market trading.BeiGene, IGM, Atreca To Work On Coronavirus Treatment Atreca Inc (NASDAQ: BCEL), Beigene Ltd (NASDAQ: BGNE) and IGM Biosciences Inc (NASDAQ: IGMS) announced plans to collaborate to develop novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19. The companies said work will commence immediately, with the financial and other terms to be finalized in the future.In pre-market trading, BeiGene was edging up 0.42% to $162.30 and Atreca was advancing 3.57% to $18.Offerings NeoGenomics, Inc. (NASDAQ: NEO) priced its proposed underwritten public offerings of 4.4 million newly issued shares at $28.50 per share. The company also said it's offering $175 million in aggregate principal amount of its 1.25% convertible senior notes due 2025.The company also said underwriters of the common stock offering are also offering 1.065 million worth of shares of NeoGenomics borrowed from third parties.View more earnings on IBBThe stock slid 4.90% to $29.50 in after-hours trading.Syndax Pharmaceuticals Inc (NASDAQ: SNDX) announced plans to offer shares of its common stock in an underwritten public offering. All the shares are being offered by the company.In pre-market trading, the stock was adding 0.27% to $18.75.Earnings Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) reported first-quarter revenues of $1.52 million, up from $858.44 million in the year-ago quarter. On a non-GAAP basis, earnings per share, or EPS, climbed from $1.14 to $2.56, ahead of the $1.84 per share consensus estimate. The company upwardly revised its full-year net product revenue guidance.The stock was adding 2.97% to $258.50 in pre-market trading.Hologic, Inc.'s (NASDAQ: HOLX) second-quarter revenues fell 7.6% to $756.1 million, primarily reflecting Cynosure divestiture. The company reported non-GAAP EPS of 57 cents, in line with the consensus. The company withdrew its guidance for the second quarter and full year.Separately, the company said it plans to launch a new Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its market-leading Panther system. The company expects to begin distributing a Research Use Only version of its test next week. It also plans to apply for Emergency Use Authorization with the FDA next week and register a CE Mark for diagnostic use in Europe later in May.In pre-market trading, the stock was jumping 9.07% to $53.39.Amarin Corporation plc's (NASDAQ: AMRN) first-quarter revenues climbed 112% to $155 million. The net loss per share on a non-GAAP basis narrowed from 5 cents to 3 cents. The results trumped the consensus that called for a loss of 7 cents per share on revenues of $137.43 million.Regarding the ANDA litigation, the company said hearing could happen in the third quarter or early fourth quarter, with a ruling likely in 2020 or in early 2021.Amarin said it believes that it has a strong basis for appeal, which will be set out in its opening brief proposed for filing on May 12th.In pre-market trading, Amarin shares were rallying 3.75% to $8.57.On The Radar Earnings • Agios Pharmaceuticals Inc (NASDAQ: AGIO) (before the market open) • ABIOMED, Inc. (NASDAQ: ABMD) (before the market open) • Baxter International Inc (NYSE: BAX) (before the market open) • BIO-TECHNE Corp (NASDAQ: TECH) (before the market open) • Genocea Biosciences Inc (NASDAQ: GNCA) (before the market open) • Novocure Ltd (NASDAQ: NVCR) (before the market open) • Syneos Health Inc (NASDAQ: SYNH) (before the market open) • PRA Health Sciences Inc (NASDAQ: PRAH) (before the market open) • Lantheus Holdings Inc (NASDAQ: LNTH) (before the market open) • Iradimed Corp (NASDAQ: IRMD) (before the market open) • Concert Pharmaceuticals Inc (NASDAQ: CNCE) (before the market open) • Amgen, Inc. (NASDAQ: AMGN) (after the close) • Emergent Biosolutions Inc (NYSE: EBS) (after the close) • Insmed Incorporated (NASDAQ: INSM) (after the close) • Gilead Sciences, Inc. (NASDAQ: GILD) (after the close) • Seattle Genetics, Inc. (NASDAQ: SGEN) (after the close) • Natus Medical Inc (NASDAQ: NTUS) (after the close) • Illumina, Inc. (NASDAQ: ILMN) (after the close) • PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close) • LeMaitre Vascular Inc (NASDAQ: LMAT) (after the close) • ResMed Inc. (NYSE: RMD) (after the close) • Viking Therapeutics Inc (NASDAQ: VKTX) (after the close) • Silk Road Medical Inc (NASDAQ: SILK) (after the close) • Corvus Pharmaceuticals Inc (NASDAQ: CRVS) (after the close) • CareDx Inc (NASDAQ: CDNA) (after the close) • Tandem Diabetes Care Inc (NASDAQ: TNDM) (after the close) • Ekso Bionics Holdings Inc (NASDAQ: EKSO) (after the close)See more from Benzinga * The Daily Biotech Pulse: Inovio's MERS Vaccine Data, Fast Track Designation For Erytech, FDA Approves Higher Dose Of Merck's Keytruda * The Daily Biotech Pulse: Pfizer Earnings, Roche's Spinal Muscular Dystrophy Treatment, Moderna COVID-19 Vaccine Update * The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

There are still unanswered questions about the accuracy of some COVID-19 tests, the prevalence of antibodies among Americans, and whether those antibodies provide the kind of immunity safety net needed to protect people from future infections.

Hologic (HOLX) exhibits robust segmental growth in second-quarter fiscal 2020, fueled by strong performance by the Diagnostics segment amid the coronavirus pandemic.

Calgary, Alberta--(Newsfile Corp. - May 15, 2020) - Braveheart Resources Inc. (TSXV: BHT) ("Braveheart" or the "Company") announces that it has received a positive system impact study ("SIS") from British Columbia Hydro and Power Authority ("BCH") on the Company's planned reconnection to grid power at a proposed load of 5 MW. The SIS determined that it is technically feasible to interconnect the proposed Bull River Mine load to the BCH transmission system. ...

The medical device maker is issuing new advice to doctors for use of its rapid test for Covid-19 after the Food and Drug Administration warned of new data suggesting the test could return false negatives.

Hologic Inc said on Friday the U.S. Food and Drug Administration granted emergency use authorization for its COVID-19 diagnostic test that can provide initial results in about three hours and process more than 1,000 tests in 24 hours. Diagnostic test makers are rushing to offer their own kits to combat the fast-spreading new coronavirus that has killed nearly 300,000 people globally and hammered financial markets. The medical device maker, which had launched its first COVID-19 test after receiving emergency use authorization in March, said it has started distribution of the latest test and expects to produce an average of 1 million tests per week.

The U.S. death toll from the coronavirus that causes COVID-19 rose above 87,000 on Saturday, as new outbreaks were reported from states where stay-at-home orders are set to expire and in states that never imposed them, raising concerns that the reopening of economies will spur new infections.

Shares of Hologic Inc. gained 1.9% in premarket trading on Friday after the company announced that it received its second emergency use authorization (EUA) for a COVID-19 test from the Food and Drug Administration. Hologic said it "expects to produce an average of one million tests per week." Funding from the Biomedical Advanced Research and Development Authority was used to develop the test. The company previously received an EUA for a molecular COVID-19 test in mid-March. Hologic's stock is down 1.5% year-to-date, while the S&P 500 is down 11.7%.

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Announcement of Periodic Review: Moody's announces completion of a periodic review of ratings of Hologic, Inc. New York, May 20, 2020 -- Moody's Investors Service ("Moody's") has completed a periodic review of the ratings of Hologic, 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.

The health care industry has been rallying so far this year on constant testing and COVID-19 vaccine trials.

Diagnostic testing, treatment, and a coronavirus vaccine could allow near-normal distancing and nonessential business recovery by mid-2021.