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Fly News Breaks for August 29, 2016
GSK, GILD
Aug 29, 2016 | 13:30 EDT
Piper Jaffray analyst Joshua Schimmer said he has received a number of questions regarding a Wall Street Journal article highlighting a potential 2-drug HIV regimen based on GlaxoSmithKline's (GSK) dolutegravir, stating in response that 2-drug options looking to replace the 3-drug standard "have come and gone without success." Though there is "always the chance that a new 2-drug combo will thread the needle," Schimmer said he still strongly doubts the field will "rush to a novel paradigm any time soon" as he believes the advantage of a 2-drug over a 3-drug regimen is minimal. Gilead (GILD) is doing a "very good job converting it's HIV Viread-based regimens to TAF based ones" and should remain the leader in the HIV space when it can also offer an unboosted integrase inhibitor, said Schimmer, who keeps an Overweight rating on the stock.
News For GILD;GSK From the Last 2 Days
GILD
Apr 25, 2024 | 17:21 EDT
Check out this evening's top movers from around Wall Street, compiled by The Fly. HIGHER AFTER EARNINGSSnap (SNAP) up... To see the rest of the story go to thefly.com. See Story Here
GILD
Apr 25, 2024 | 16:02 EDT
Reports Q1 revenue $6.7B, consensus $5.92B. "Gilead delivered another strong quarter of revenue growth in the first quarter with 6% year-over-year growth in our base business driven by HIV, Oncology and Liver Disease," said Daniel O'Day, Gilead's Chairman and Chief Executive Officer. "The acquisition of CymaBay brings us another potentially transformative therapy for people with liver disease, and a regulatory decision on seladelpar is expected in August. New HIV data demonstrates the continued progress in our long-acting HIV pipeline, and we look forward to providing updates on this and our broad Oncology portfolio throughout the rest of 2024."
GSK
Apr 24, 2024 | 07:56 EDT
Due to a rapidly changing epidemiological environment following the end of the COVID-19 pandemic, CureVac and GSK decided to end the Pandemic Preparedness Agreement jointly concluded with the Federal Republic of Germany in April 2022. This decision was made after consultation with the German Federal Ministry of Health and the German Center for Pandemic Vaccines and Therapeutics. The agreement included the provision of production capacity and supply of mRNA-based vaccines in the event of a public health emergency in Germany. Termination will take effect on May 31, 2024, with no further financial obligations. Completion of CureVac's GMP IV manufacturing plant for the production mRNA-based vaccines is unaffected and progressing. Contingent upon regulatory approval, the facility is expected to be certified in the second half of 2024.
GSK
Apr 24, 2024 | 07:29 EDT
CureVac (CVAC) announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A pre-pandemic vaccine candidate developed in collaboration with GSK (GSK). The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based on CureVac's proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen. The combined Phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of an investigational influenza A pre-pandemic vaccine candidate in healthy younger adults aged 18 to 64 and healthy older adults aged 65 to 85. In the initial Phase 1 dose-escalation part of the study, up to five dose levels will be assessed compared to a placebo control. The study will be conducted in the United States. The broad CureVac-GSK infectious disease collaboration was first announced in July 2020. It focuses on applying CureVac's mRNA-technology to the development of new products for infectious disease targets.