|Bid||41.00 x 1300|
|Ask||41.90 x 900|
|Day's Range||40.95 - 41.28|
|52 Week Range||31.43 - 48.25|
|Beta (5Y Monthly)||0.44|
|PE Ratio (TTM)||41.55|
|Earnings Date||Feb 01, 2017 - Feb 06, 2017|
|Forward Dividend & Yield||1.89 (4.58%)|
|Ex-Dividend Date||May 14, 2020|
|1y Target Est||47.70|
GlaxoSmithKline's HIV business ViiV is within weeks of resubmitting its request for approval of its long-acting injection Cabenuva to U.S. drug regulators, ViiV's head of research said on Thursday. ViiV executive Kimberly Smith told a media briefing that the company would stick to its previous guidance of refiling the request around mid-year and that this would happen "within weeks".
GlaxoSmithKline (GSK) closed at $40.55 in the latest trading session, marking a -1.39% move from the prior day.
Sanofi SA (NASDAQ: SNY), which is in the race to develop a vaccine for SARS-CoV-2, which causes COVID-19, is unveiling an accelerated timeline for the vaccine program it is pursuing with GlaxoSmithKline plc (NYSE: GSK).Sanofi has also expanded its collaboration with mRNA vaccine company Translate Bio Inc (NASDAQ: TBIO).Sanofi Moves Up Vaccine Rollout Timeline: Sanofi said it expects to begin a Phase 1/2 study of the recombinant protein vaccine candidate it is co-developing with GlaxoSmithKline in September, and full approval is likely to be obtained at the earliest by the first half of 2021, the company said at its Virtual R&D Investor Day.GlaxoSmithKline is contributing its adjuvant AS03.In mid-April, when the companies announced the collaboration, they gave a timeline of the second half of 2021 for the probable commercial launch of the vaccine."Sanofi is advancing the only vaccine in the race that's off a proven platform that works at scale," Fierce Pharma reported, quoting Sanofi CEO Paul Hudson.Hudson expressed skepticism regarding the efficacy and the ability to scale manufacturing of the new breed of vaccines being developed by frontrunners working on the coronavirus. Translate Bio Pact: Sanofi is also strengthening its vaccine partnership with Translate Bio.The proposed expanded relationship is a collaboration and licensing agreement with the smaller biopharma to develop mRNA vaccines for infectious diseases, including COVID-19.Sanofi and Translate Bio are in the process of shortlisting a coronavirus mRNA vaccine candidate from animal studies and intend to start human trials in the fourth quarter of 2020.SNY Price Action: At last check, Sanofi shares were up 0.53% at $52.78.Related Links:The Week Ahead In Biotech: Karyopharm, Zogenix, Heron, Chiasma On The Radar Ahead Of FDA Decisions The Daily Biotech Pulse: Sanofi Expedites COVID-19 Vaccine Timeline, Apyx Cleared For Market Expansion, Miragen's Positive Readout See more from Benzinga * The Daily Biotech Pulse: Sanofi Expedites COVID-19 Vaccine Timeline, Apyx Cleared For Market Expansion, Miragen's Positive Readout * The Daily Biotech Pulse: Eloxx Resumes Cystic Fibrosis Study, Rexahn's Reverse Merger, Ultragenyx, Epizyme Await FDA Decisions(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Sanofi said Tuesday (June 23) it expects to get approval for a potential coronavirus vaccine by the first half of next year - faster than was previously thought. The French drugmaker is developing the medicine with Britain's GlaxoSmithKline. In April, they had said the vaccine would be available in the second half of 2021. Many drugmakers are racing to come up with a safe and effective vaccine that can be produced on a large scale. Moderna, AstraZeneca and Pfizer all moved to human trials as early as March. But Sanofi CEO Paul Hudson said their rivals were not assured of securing victory - and claimed moving at speed could lead to less effective results. He said the probability of success for his company is 'higher than anybody else'. Sanofi is currently working on two vaccine projects. Clinical trials of the drug developed with GSK are due to start in September. Sanofi said trials of a separate vaccine should begin around the end of 2020. The drugmaker said it had capacity to produce up to 1 billion doses a year of the vaccine it is working on with GSK.
French drugmaker Sanofi SA said on Tuesday it expects to get approval for the potential COVID-19 vaccine it is developing with Britain's GlaxoSmithKline Plc by the first half of next year, faster than previously anticipated. Sanofi, which is hosting a virtual research and development event, and GSK had said in April the vaccine, if successful, would be available in the second half of 2021. "We are being guided by our dialogue with regulatory authorities," Sanofi research chief John Reed told reporters, when asked about the accelerated time frame.
Glaxo (GSK) has several collaborations to make its pandemic adjuvant technology available to partners who are making adjuvanted COVID-19 vaccine candidates.
There is a notable name missing from the frontrunners in the race to test experimental immunisations against the novel coronavirus: the world's largest vaccine maker GlaxoSmithKline <GSK.L>. The company laid out plans in May to produce 1 billion doses of the efficacy boosters for COVID-19 shots next year, compared to the 700 million or so vaccine doses against a range of diseases it usually produces in a year.
Moody's Investors Service ("Moody's") has assigned an A2 rating to GSK Finance (No.3) plc's new exchangeable senior unsecured notes due 2023. - the proposed exchangeable notes do not provide loss absorption, in part because they could not lead to new equity creation.
FDA approves Glaxo's (GSK) oral suspension formulation of its three-drug regimen for HIV, Tivicay, as a treatment for patients aged at least four weeks and weighing at least 3kg.
Shares of GlaxoSmithKline were down 0.05% in premarket trading on Monday after the Food and Drug Administration late on Friday approved its HIV drug Tivicay as a treatment for infants and children. Tivicay is the company's second-best selling drug in its HIV portfolio. About 2,200 children in the U.S. had been diagnosed with HIV in 2016, according to statistics provided by the Centers for Disease Control and Prevention. GSK's stock has gained 14.9% since the start of the year. The S&P 500 is down 5.8% year-to-date. The FDA is granting the approval of Tivicay and Tivicay PD to ViiV Healthcare.
The U.S. Food and Drug Administration has approved a drug to treat infants and children with HIV, with the drug having been developed by drugmaker GlaxoSmithKline's HIV drugs division ViiV Healthcare, the FDA and the GSK unit said. The FDA said on Friday it was granting Viiv the approval of Tivicay and Tivicay PD tablets "for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kgs in combination with other antiretroviral treatments". The drug is currently under review by the European Medicines Agency, ViiV, in which Pfizer and Shionogi have small stakes, said in a separate statement.
GlaxoSmithKline (LSE/NYSE: GSK) announced that Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1% (NSAID) arthritis pain reliever) recently became available over-the-counter (OTC) online and in stores nationwide, providing the over 30 million1 osteoarthritis patients across the country broader access to a leading pain relief option.
Two drugs used to treat inflammatory diseases and cancer are being tested as potential therapies for patients with COVID-19, the Universities of Birmingham and Oxford announced on Wednesday. Severe cases of COVID-19 are believed to be triggered by an over-reaction of the immune system, known as a cytokine storm, and researchers are investigating whether drugs that suppress certain elements of the immune system can play a role in arresting a rapid escalation of symptoms. Izana Bioscience's Namilumab, a monoclonal antibody already in late-stage tests to treat rheumatoid arthritis and an inflammatory disease called ankylosing spondylitis, is the first of four candidates in the CATALYST trial.