Regeneron says Sanofi to have sole Praluent responsibility outside U.S. » 17:0904/0604/06/20
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Fly Intel: Wall Street's top stories for Monday » 16:5704/0604/06/20
DAL, UAL, JBLU, LUV, ALK, BA, EADSY, ZM, MSFT, FB, TSN, IMMU, W, CODX, CCL, LK, SMPL
Stocks jumped to start…
Fly Intel: Wall Street's top stories at midday » 13:2104/0604/06/20
DAL, UAL, JBLU, BRK.A, BRK.B, LUV, BA, ZM, MSFT, IMMU, W, CODX, CCL, CUK, LK, SMPL
The S&P, Dow and…
Cantor pharma/biotech analysts to hold analyst/industry conference call » 10:2504/0604/06/20
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Cantor Fitzgerald Pharmaceuticals Analyst Chen & Kim, Biotech Analysts Young, Kumar & Kluska, along with Dr. Robert Fine from New York-Presbyterian/Columbia University Medical Center review current treatment paradigm for advanced and metastatic colorectal cancer (CRC) and discuss new treatments for CRC on an Analyst/Industry conference call to be held on April 6 at 11 am.
Unusually active option classes on open April 6th » 09:4004/0604/06/20
MNK, PENN, LUV, DAL, USO, ACB, M, MSFT, TEVA, GILD
Unusual total active…
Unusual total active option classes on open include: Mallinckrodt (MNK), Penn National (PENN), Southwest (LUV), Delta Air Lines (DAL), United States Oil Fund (USO), Aurora Cannabis (ACB), Macy's (M), Microsoft (MSFT), Teva (TEVA), and Gilead (GILD).
Fly Intel: Pre-market Movers » 09:1104/0604/06/20
CODX, AXSM, SEAS, TEN, XBIT, TSLA, SMPL, DGLY, DAL, TDY, MNLO
Check out this morning's…
GlaxoSmithKline, Vir Biotechnology collaborate for coronavirus solutions » 08:5404/0604/06/20
GlaxoSmithKline plc (GSK)…
GlaxoSmithKline plc (GSK) and Vir Biotechnology, Inc. (VIR) announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines. Due to the urgent patient need for COVID-19 solutions, the initial focus of the collaboration will be to accelerate the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832, that have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralising SARS-CoV-2 in live virus-cellular assays. Subject to regulatory review, the companies plan to proceed directly into a phase 2 clinical trial within the next three to five months. The collaboration will also utilise Vir's CRISPR screening and machine learning approach to identify cellular targets whose inhibition can prevent viral infection. Vir has identified multiple potential targets against flu and other respiratory pathogens, as well as hepatitis B virus, and will now focus on SARS-CoV-2. Additionally, the companies have also agreed to conduct research into SARS-CoV-2 and other coronavirus vaccines by coupling GSK's vaccines technologies and expertise with Vir's ability to identify neutralising epitopes that are present across entire viral families. These efforts will be additive to other initiatives GSK is advancing to develop a potential vaccine for COVID-19. In addition, to gain access to Vir's technology, GSK will make an equity investment in Vir of $250M, priced at $37.73, a 10% premium to the closing share price on Friday, March 27, 2020. The equity investment and collaboration agreement will complete at the same time and are conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.
Inovio: FDA accepts IND application for INO-4800 » 08:4104/0604/06/20
Inovio announced that the…
Inovio announced that the U.S. FDA has accepted the company's Investigational New Drug application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing is planned for April 6.
Co-Diagnostics COVID-19 test obtains EUA from FDA » 06:3404/0604/06/20
Co-Diagnostics announced that its Logix Smart coronavirus COVID-19 Test has obtained emergency use authorization, or EUA, by the FDA to be used for the diagnosis of SARS-CoV-2. The company's test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments, or CLIA, to detect the presence of the virus that causes COVID-19, and is available for purchase from the company's Utah-based facility. Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs in March as a result of the FDA's policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the company had initiated sales of its CE-IVD test to the European community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration. The Co-Diagnostics Logix Smart coronavirus COVID-19 Test uses the company's patented CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus. The advanced nature of CoPrimers has allowed Co-Diagnostics to design a highly-specific, single-well PCR test, allowing higher throughput over tests that require multiple wells.
Gilead, Second Genome collaborate on IBD treatments » 06:1704/0604/06/20
Gilead Sciences and…
Gilead Sciences and Second Genome announced that the companies have entered into a four-year strategic collaboration to identify biomarkers associated with clinical response in up to five of Gilead's pipeline compounds in inflammation, fibrosis and other diseases, and to identify potential new targets and drug candidates for the treatment of inflammatory bowel disease. Under the terms of the agreement, Second Genome will utilize its proprietary Microbiome Analytics Platform to identify novel biomarkers associated with clinical response to Gilead's investigational medicines. This work will harness the latest insights in microbiome science to help inform patient stratification and optimize potential treatments for patients in the future. The platform, in combination with additional discovery and development tools, will also seek to identify new targets and drug candidates relevant to IBD. This will include the identification of up to five novel IBD targets or drug candidates over the next four years, with an option to extend the collaboration for an additional two years. Second Genome will receive $38M in an upfront payment, and up to approximately $300M in success-based preclinical, clinical, regulatory and commercial milestones for each of five target discovery programs as well as low double-digit royalties for any approved products. In addition, it will receive success-based milestones for each validated biomarker delivered under the agreement. Gilead will have the option to worldwide rights for up to five programs for all diseases as well as exclusive rights to all biomarkers developed under the collaboration.