GRFS News

Grifols, S.A. ("Grifols") (MCE: GRF) (MCE: GRF.P) (NASDAQ: GRFS) announced that it has filed its 2019 Annual Report on Form 20-F with the United States Securities and Exchange Commission ("SEC") on April 6, 2020. Grifols' Annual Report on Form 20-F includes its audited financial statements for its fiscal year ended December 31, 2019.

Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs March 25.) * Ra Pharmaceuticals Inc (NASDAQ: RARX)Down In The Dumps (Biotech stocks that hit 52-week lows March 25.) * Anixa Biosciences Inc (NASDAQ: ANIX) * IMMUTEP LTD/S ADR (NASDAQ: IMMP) (reacted to breast cancer trial readout) * PLx Pharma Inc (NASDAQ: PLXP) * Taro Pharmaceutical Industries Ltd. (NYSE: TARO)Stocks In Focus Quidel COVID-19 Detection Assay Obtains Expanded EUA, CE Mark Approval Quidel Corporation (NASDAQ: QDEL) said its Lyra SARS-CoV-2 Assay has received expanded Emergency Use Authorization from the FDA to allow testing with three additional thermocyclers, namely Applied Biosystems' 7500, Roche Holdings AG's (OTC: RHHBY) LightCycler 480 and Qiagen NV's (NYSE: QGEN) Rotor Gene Q.Quidel said the initial EUA awarded allowed qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19. The expanded authorization includes nasal and nasal turbinate swabs.Quidel also said it received the CE-Mark on March 25, which will allow it market and sell the Lyra SARS-CoV-2 Assay in Europe as well as other countries that accept CE Mark.Alector Out-Licenses China Rights of AL008 In Oncology To Innovent Biologics Alector Inc (NASDAQ: ALEC) and Hong Kong-listed biopharma Innovent Biologics said they have entered into a licensing agreement to develop and commercialize an anti-SIRP-alpha antibody AL008 for the treatment of oncology indications in China.The companies did not disclose the financial terms of the deal. The agreement gives Innovent the responsibility of leading development and commercialization of the investigational compound in China, while Alector is in charge of developmental activities outside of China.See also: The Week Ahead In Biotech: Bristol-Myers, Rockwell Medical Await FDA Decisions, COVID-19 Updates In Focus Bristol-Myers Squibb Receives FDA Nod For Celgene's Multiple Sclerosis Drug Bristol-Myers Squibb Co (NYSE: BMY) announced FDA approval for ozanimod 0.92 mg as a treatment option for patients with relapsing forms of multiple sclerosis.In premarket trading Thursday, Bristol-Myers Squibb shares were adding 1.52% to $50.10.Cerecor To Test Role Of Inflammatory Cytokinin In COVID-19-Induced Acute Respiratory Distress Cerecor Inc (NASDAQ: CERC) said it plans to explore the role of an inflammatory cytokine -- LIGHT -- in patients with COVID-19-induced acute respiratory distress. It said it will use its proprietary free LIGHT assay as well as multiple assay to determine if there are differences in LIGHT levels and other inflammatory markers, including IL-18 and IFN-g, in patients with mild-to-moderate vs. severe disease with Acute Lung Injury or Acute Respiratory Distress Syndrome.Grifols To Develop Hyperimmune Globulin For COVID-19 Grifols SA - ADR (NASDAQ: GRFS) said it has entered a formal collaboration agreement with the U.S. BARDA, the FDA and other federal public health agencies to collect plasma from convalescent COVID-19 patients and process this specific plasma into a hyperimmune globulin.The company also said it will support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can be used to treat COVID-19 disease.In Spain, Grifols is working on a clinical trial with inactivated plasma from recovered patients through a collaboration with select donation centers and public hospitals.View more earnings on IBBThe company also said it has accelerated the development and validation of a proprietary technology transcription-mediated amplification-based diagnostic procedure to detect the virus, with a sensitivity equivalent or even superior to that of PCR test.The stock was rising 10.47% to $19.63 in premarket trading.Pfizer, Mylan Announce Delay In Merger Of Generic Businesses Pfizer Inc. (NYSE: PFE) and Mylan NV (NASDAQ: MYL) announced the proposed merger between Mylan and Pfizer's generic unit Upjohn will now close in the second half of 2020 due to the unprecedented circumstances surrounding the COVID-19 pandemic, including associated delays in the regulatory review process. The companies initially had a closing deadline of mid-2020.Biopharmx Gets Delisting Notice From NYSE American Specialty pharma company Biopharmx Corp (NYSE: BPMX) said it received a notification from NYSE American LLC on March 24 regarding its determination to delist the company's shares from the exchange. The decision is due to the company's non-compliance with certain continued listing standards.Biopharmx said it will appeal the delisting notice. The shares, according to the company, will continue to trade on the exchange during the appeal period.The company also clarified that the delisting does not affect its business operations, its intention to merge with Timber Pharma announced Jan. 28 or its SEC reporting requirements,The stock was down 2.83% at 28 cents at the time of publication.Xencor, Vir Agree To License Technology To Extend Half-Life Of COVID-19 Treatment Candidates Xencor Inc (NASDAQ: XNCR) said it entered into a technology license agreement with Vir Biotechnology Inc (NASDAQ: VIR) that provides Vir non-exclusive access to Xencor's Xtend Fc technology to extend the half-life of novel antibodies Vir is investigating as a potential treatment for COVID-19."Xtend Fc technology has demonstrated, in multiple antibodies and through numerous human clinical trials, the ability to extend antibody drug half-life and reduce dosing frequency in patients, an important feature in anti-viral therapy for pandemic use," Xencor CEO Bassil Dahiyat said in a statement. The companies did not disclose the financial terms of the deal.Vir shares were trading 3.22% higher at $31.74 in Thursday's premarket session.Earnings Biocept Inc's (NASDAQ: BIOC) fourth-quarter revenue climbed 108% year-over-year to $1.8 million. The net loss narrowed significantly from $1.43 per share to 20 cents per share. Analysts estimated a loss of 10 cents per share.The stock was trading 8.57% higher at 38 cents at the time of publication. On The Radar PDUFA Dates IntelGenx Technologies Corp.'s (OTC: IGXT) NDA for rizaport versafilm for the treatment of acute migraine is pending before the FDA, with the target action day fixed for Thursday. The company had faced three rejections for the investigational drug in the past.Earnings * Celsion Corporation (NASDAQ: CLSN) (before the market open) * Entera Bio Ltd (NASDAQ: ENTX) (before the market open) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) (before the market open) * IGM Biosciences Inc (NASDAQ: IGMS) (after the close) * NovaBay Pharmaceuticals, Inc. (NYSE: NBY) (after the close) * Vermillion, Inc. (NASDAQ: VRML) (after the close) * aTyr Pharma Inc (NASDAQ: LIFE) (after the close)Related Link: Hoth Therapeutics Shares Jump On COVID-19 Vaccine Development Plans See more from Benzinga * The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company with a track record of more than 100 years and a recognized leader in the development and production of plasma-derived medicines, today announced it has begun identifying, screening and selecting volunteer donors who have recovered from COVID-19 to donate their plasma in select U.S. cities.

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Grifols today announces that it has entered into a formal collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients, process this specific plasma into a hyperimmune globulin and support the necessary preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease. Grifols will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies; process plasma into hyperimmune globulin in its purpose-built facility in Clayton, North Carolina, for the isolated processing of immune globulins to treat emerging infectious diseases; and support preclinical and clinical studies to determine whether hyperimmune globulin made from the plasma of convalescent donors can live up to its promise as a viable treatment for COVID-19 disease and as a platform for the treatment of future emerging infectious diseases.

Image source: The Motley Fool. Repro-Med Systems, or KORU Medical Systems (NASDAQ: KRMD)Q1 2020 Earnings CallMay 05, 2020, 9:00 a.m. ET Contents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: Operator Greetings and welcome to the KORU Medical Systems reports first-quarter 2020 financial results.

Grifols (GRFS) has been upgraded to a Zacks Rank 1 (Strong Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Worst hit is Italy. Close behind is Spain, which said on Saturday that its death toll from the virus-caused Covid-19 illness had reached more than 1,300 after having surpassed 1,000 the previous day. Spain has just completed the first week of a national lockdown.

Spain's Grifols has agreed to work with the U.S. Food and Drug Administration and other agencies to gather plasma from patients who have recovered from COVID-19 and test potential therapies for the disease, the pharmaceutical firm said on Wednesday. The plasma will be processed to produce hyperimmune immunoglobins, which will then be put to pre-clinical and clinical tests to see if they can help treat the disease, Grifols said in a statement.

Grifols (GRFS) has seen solid earnings estimate revision activity over the past two months, and belongs to a strong industry as well.

While the world battles the COVID-19 pandemic, a drugmaker with a massive presence in North Carolina is looking for recovered COVID-19 patients to donate plasma toward the cause – and if successful, will mass-produce a treatment in Johnston County.

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Grifols (MCE:GRF, MCE:GRF.P NASDAQ:GRFS), a leading global producer of plasma-derived medicines, today announced the launch of a new 3-mL (900-IU) vial for HyperRAB (rabies immune globulin [human]), a treatment for rabies postexposure prophylaxis.

We hate to say this but, we told you so. On February 27th we published an article with the title Recession is Imminent: We Need A Travel Ban NOW and predicted a US recession when the S&P 500 Index was trading at the 3150 level. We also told you to short the market and buy […]

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.

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Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced that it has received FDA approval for the Procleix Panther System featuring ART for use with the following U.S. licensed products: Procleix Ultrio Elite Assay, Procleix WNV Assay, Procleix Zika Virus Assay and the Procleix Babesia Assay.

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