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Fly News Breaks for December 14, 2018
GSK, TSRO, CLVS
Dec 14, 2018 | 11:03 EDT
Leerink analyst Andrew Berens noted that GlaxoSmithKline (GSK) and Tesaro (TSRO) disclosed background details for their deal agreement in a filing this morning. The documents show several parties were interested in a strategic transaction with Tesaro at various points over the last year, though the strategic interest appears to have been driven by Glaxo and one additional company, identified as "Party A", Berens said. It is not clear why the six other contacted parties were not interested in pursuing a strategic transaction, but he thinks Party A's co-promote proposal and the initial interest of other potential acquirers indicates strategic interest in the economics surrounding a PARP. Berens, who continues to see Clovis (CLVS) being well-positioned as the remaining stand-alone PARP-focused company, keeps an Outperform rating on Clovis and Market Perform rating on Tesaro.
News For CLVS;TSRO;GSK From the Last 2 Days
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.