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Precipio, Inc. (PRPO)

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  • GlobeNewswire

    Precipio Announces Q2-2020 Corporate Update Call For Shareholders

    Conference Call to be held on Monday, August 17th, 2020 at 5:00 PM ESTNEW HAVEN, Conn., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), will be hosting its Q2-2020 corporate update call on Monday, August 17th at 5:00 PM ET. The call will include updates on the company’s current core businesses, as well as an update on the company’s COVID-19 testing initiative. The conference call may be accessed by calling 844-695-5519 (international callers dial 1-412-902-6760). All callers should ask for the Precipio Inc. conference call. Participants may also pre-register for the conference call at http://dpregister.com/10147220 and will receive a calendar invite and a direct dial-in number, bypassing the operator.Listeners interested in submitting questions in advance should email their questions to investors@precipiodx.com and management will do its best to address those questions during the call.A replay of the call will be available approximately 24 hours after the call and may be accessed via the Investors page on Precipio's website, http://www.precipiodx.com/investors.html.About PrecipioPrecipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, among others, statements related to the expected or potential impact of the novel coronavirus (COVID-19) pandemic, and the related responses of the government, consumers, and the company, on our business, financial condition and results of operations, and any such forward-looking statements, whether concerning the COVID-19 pandemic or otherwise, involve risks, assumptions and uncertainties. Except for historical information, statements about future volumes, sales, growth, costs, cost savings, margins, earnings, earnings per share, diluted earnings per share, cash flows, plans, objectives, expectations, growth or profitability are forward-looking statements based on management’s estimates, beliefs, assumptions and projections. Words such as “could,” “may,” “expects,” “anticipates,” “will,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “predicts,” and variations on such words, and similar expressions that reflect our current views with respect to future events and operational, economic and financial performance, are intended to identify such forward-looking statements. These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed. Important factors that could affect performance and cause results to differ materially from management’s expectations, or could affect the company’s ability to achieve its strategic goals, include the uncertainties relating to the impact of COVID-19 on the company’s business, operations and employees and the other factors that are described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis” in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated from time to time in the company’s Securities and Exchange Commission filings. The company’s forward-looking statements in this press release are based on management’s current views, beliefs, assumptions and expectations regarding future events and speak only as of the date of this release. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by the federal securities laws. CONTACT: Inquiries: investors@precipiodx.com +1-203-787-7888 Ext. 523

  • GlobeNewswire

    Precipio Launches Covid-19 Antibody Test in its CLIA laboratory

    Test initially offered to Precipio’s customer base, then expanding distribution reachNEW HAVEN, Conn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced it has completed the internal validation of the FDA-approved COVID-19 serology antibody test in its CLIA laboratory, and has launched the test commercially to its pathology customer base (phase 1). Upon obtaining further approval for expanded use by FDA, phase 2 will broaden our distribution to POC (point-of-care) healthcare facilities including hospitals, medical centers, urgent care facilities and physician practices. Physicians will be able to conduct a simple blood draw from each patient who wishes to be tested. The samples will be shipped overnight to Precipio’s laboratory in New Haven, where they will be received the next day, tested, and results shall be returned to the physician the same day, offering a 24-hour turnaround (subject to volume and capacity capabilities). Reimbursement is approximately $45 per test. Precipio is currently able to process 1,000 tests per day, increasing testing capacity to 10,000 tests per day by the end of Q3-20 as demand grows.Physicians and other non-medical groups wishing to utilize our rapid testing services may contact us at covidtest@precipiodx.com, or by calling us at 203.787.7888.While this ramp up has required a modest capital investment, management believes that the company is adequately financed, and has the appropriate access to capital for the company’s current operating cash needs, through its existing equity line. At this time, Management has not, and does not anticipate conducting a public offering in the foreseeable future.“Providing immediate access and rapid results to our customer base is our first phase of commercializing our COVID-19 antibody test, in line with our strong level of service and commitment to our customers”, said Ilan Danieli, Precipio’s CEO. “As we continue to execute on our strategy, we aim to bring increasing value to our customers and to the company.”About PrecipioPrecipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, among others, statements related to the expected or potential impact of the novel coronavirus (COVID-19) pandemic, and the related responses of the government, consumers, and the company, on our business, financial condition and results of operations, and any such forward-looking statements, whether concerning the COVID-19 pandemic or otherwise, involve risks, assumptions and uncertainties. Except for historical information, statements about future volumes, sales, growth, costs, cost savings, margins, earnings, earnings per share, diluted earnings per share, cash flows, plans, objectives, expectations, growth or profitability are forward-looking statements based on management’s estimates, beliefs, assumptions and projections. Words such as “could,” “may,” “expects,” “anticipates,” “will,” “targets,” “goals,” “projects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “predicts,” and variations on such words, and similar expressions that reflect our current views with respect to future events and operational, economic and financial performance, are intended to identify such forward-looking statements. These forward-looking statements are only predictions, subject to risks and uncertainties, and actual results could differ materially from those discussed. Important factors that could affect performance and cause results to differ materially from management’s expectations, or could affect the company’s ability to achieve its strategic goals, include the uncertainties relating to the impact of COVID-19 on the company’s business, operations and employees and the other factors that are described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis” in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as updated from time to time in the company’s Securities and Exchange Commission filings.The company’s forward-looking statements in this press release are based on management’s current views, beliefs, assumptions and expectations regarding future events and speak only as of the date of this release. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by the federal securities laws.  CONTACT: Inquiries: investors@precipiodx.com +1-203-787-7888 Ext. 523

  • The Daily Biotech Pulse: Sanofi-GSK Land $2.1B Funding For Coronavirus Vaccine, D-Day For GW Pharma, FDA Nod For Roche
    Benzinga

    The Daily Biotech Pulse: Sanofi-GSK Land $2.1B Funding For Coronavirus Vaccine, D-Day For GW Pharma, FDA Nod For Roche

    Scaling The Peaks (Biotech Stocks Hitting 52-week Highs July 30) * Achieve Life Sciences Inc (NASDAQ: ACHV) * Annexon Inc (NASDAQ: ANNX) (IPOed July 24) * Atossa Therapeutics Inc (NASDAQ: ATOS) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * Bio-Rad Laboratories, Inc. Class B (NYSE: BIO-B) * Catalent Inc (NYSE: CTLT) * Dr.Reddy's Laboratories Ltd (NYSE: RDY * Edesa Biotech Inc (NASDAQ: EDSA)(announced filing of an IND for a Phase 2/3 study of a COVID treatment candidate) * Hologic, Inc. (NASDAQ: HOLX) * Horizon Therapeutics PLC (NASDAQ: HZNP) * Immunic Inc (NASDAQ: IMUX) * Ligand Pharmaceuticals Inc. (NASDAQ: LGND) * Merit Medical Systems, Inc. (NASDAQ: MMSI) * NeoGenomics, Inc. (NASDAQ: NEO) * OraSure Technologies, Inc. (NASDAQ: OSUR) * Penumbra Inc (NYSE: PEN) * Precipio Inc (NASDAQ: PRPO)( announced a distribution agreement for its FDA-authorized COVID-19 serology antibody tests) * Repligen Corporation (NASDAQ: RGEN) * TIZIANA LF SCIE/S ADR (NASDAQ: TLSA) * Veracyte Inc (NASDAQ: VCYT) * Zoetis Inc (NYSE: ZTS)Down In The Dumps (Biotech Stocks Hitting 52-week Lows July 30) * Acorda Therapeutics Inc (NASDAQ: ACOR) * Genfit SA (NASDAQ: GNFT) * Gritstone Oncology Inc (NASDAQ: GRTS) * Happiness Biotech Group Ltd (NASDAQ: HAPP) * Orchard Therapeutics PLC - ADR (NASDAQ: ORTX) * ORIC Pharmaceuticals Inc (NASDAQ: ORIC) * Pandion Therapeutics Holdco LLC (NASDAQ: PAND) * RA Medical Systems Inc (NYSE: RMED) * Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) * Tricida Inc (NASDAQ: TCDA) * Verrica Pharmaceuticals Inc (NASDAQ: VRCA)Stocks In Focus Pfizer/BioNTech Agrees to Supply 120M Doses of Coronavirus Vaccine to Japan Pfizer Inc. (NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) announced an agreement with the Ministry of Health, Labour and Welfare in Japan to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, beginning in the first half of 2021.The companies have already signed agreements with the U.K. and U.S. governments for supplying BNT162.Tiziana Applies For Patent For Nasal Administration of its Monoclonal Antibody as a Potential COVID-19 Cure Tiziana said it has submitted a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of COVID-19, either alone or in combination with other anti-viral drugs.The stock was soaring 47.53% to $7.30 in pre-market trading Friday.Roche's Combo Therapy Gets FDA Nod For Skin Cancer Roche Holdings AG (OTC: RHHBY) said the FDA approved Tecentriq plus Cotellic and ZelboraF for the treatment of BRAF V600 mutation-positive advanced melanoma patients.Sanofi/GSK Gets $2.1B U.S. Government Funding For COVID-19 Vaccine Supply Sanofi SA (NASDAQ: SNY) and GlaxoSmithKline plc (NYSE: GSK) announced an agreement with the U.S. government under the Operation Warp Speed project, for up to $2.1 billion in funding, more than half of which is to support further development of the vaccine, including clinical trials, with the remainder used for manufacturing scale-up and delivery of an initial 100 million doses of the vaccine. Sanofi will receive the majority of the funding.The U.S. government has a further option for the supply of an additional 500 million doses longer term, the companies said.Axovant Announces Manufacturing Supply Agreement With U.K. Gene Therapy Company Axovant Gene Therapies Ltd (NASDAQ: AXGT) said its subsidiary has signed a three-year Clinical Supply Agreement with U.K.'s Oxford Biomedica plc, under which the latter will manufacture GMP batches for Axovant to support the ongoing and future clinical development of AXO-Lenti-PD, a clinical-stage gene therapy product to treat moderate to severe Parkinson's Disease.J&J's Psoriasis Drug Gets Label Expansion; Coronavirus Vaccine Produces Positive Results in Pre-clinical Studies Johnson & Johnson's (NYSE: JNJ) Janssen unit said the FDA approved an expanded indication for Stelara as a treatment for pediatric patients, who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis.Separately, J&J announced publication in the journal Nature results of preclinical studies of its adenovirus serotype 26 vector-based vaccine, which showed the investigational vaccine elicited a robust immune response as demonstrated by "neutralizing antibodies," successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates. The company expects to commence Phase 3 studies in September.Earnings Corvus Pharmaceuticals Inc's (NASDAQ: CRVS) second-quarter loss narrowed from the year-ago period but was wider than the consensus estimate.The stock fell 6.32% to $4 in after-hours trading.Opko Health Inc. (NASDAQ: OPK) said its second-quarter revenues increased from $226.4 million to $301.2 million. The company reversed from a loss of 10 cents per share to a profit of 5 cents per share.View more earnings on IBBThe stock lost 6.09% to $5.55 in after-hours trading.Emergent Biosolutions Inc (NYSE: EBS) reported a 62.3% year-over-year jump in second-quarter revenues and its adjusted EPS exceeded estimates. The company raised its 2020 guidance.The shares were climbing 6.04% to $102.82.Gilead Sciences, Inc. (NASDAQ: GILD) said its second-quarter revenues fell from $5.7 billion in 2019 to $5.1 billion in 2020. The non-GAAP EPS fell from $1.72 to $1.11, missing the consensus estimate of $1.45. The company raised its product sales and EPS guidance for the full year.Gilead shares were retreating 3.43% to $69.85.DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT) reported a higher operating income for the first half but its net loss widened year-over-year.The stock was advancing 8.05% to $4.16.On The Radar PDUFA Dates GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) awaits FDA verdict on its sNDA for Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.Earnings AbbVie Inc (NYSE: ABBV) (before the market open) ImmunoGen, Inc. (NASDAQ: IMGN) (before the market open) GlycoMimetics Inc (NASDAQ: GLYC) (before the market open)See more from Benzinga * The Daily Biotech Pulse: Bristol-Myers, Bluebird Bio Resubmit Multiple Myeloma Drug BLA, FSD To Close Medicinal Cannabis Business, Hologic's Blowout Quarter * The Daily Biotech Pulse: Merck's Breakthrough Therapy Designation, Sonoma Surges On Sanitizer News, Sanofi-Glaxo And More * The Daily Biotech Pulse: Spectrum's Positive Dementia Readout, Pfizer, BioNTech Start Late-Stage Coronavirus Trial, resTORbio Receives COVID-19 Funding(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.