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Fly News Breaks for December 4, 2018
TSRO, GSK, CLVS
Dec 4, 2018 | 09:41 EDT
As previously reported, Leerink analyst Andrew Berens upgraded Clovis Oncology (CLVS) to Outperform from Market Perform after the European Patent Office upheld claims of a European patent on Rubraca. He said the finding of inventiveness in Europe strengthens his confidence in the U.S. patent estate and removes a near-term intellectual property overhang on Clovis shares. Berens now sees a 50% chance of branded exclusivity through 2023 in the U.S. in the "worst case" and through 2031 in the "best case." He also said Glaxo's (GSK) acquisition of competitor Tesaro (TSRO) brings a "return of optionality" to Clovis shares. Berens raised his price target on Clovis to $40 from $22.
News For CLVS;GSK;TSRO From the Last 2 Days
GSK
Apr 17, 2024 | 06:13 EDT
GSK announced positive results from the pivotal EAGLE-1 phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea in adolescents and adults. These results will be presented on 30 April 2024 at the European Society of Clinical Microbiology and Infectious Diseases, ESCMID, Global in Barcelona, Spain. The results from EAGLE-1 are based on a primary endpoint of microbiological response at the Test-of-Cure visit 3-7 days after treatment. The trial showed that gepotidacin was non-inferior with 92.6% success rates when compared to 91.2% success rates for intramuscular ceftriaxone plus oral azithromycin combined therapy, a leading combination treatment regimen for gonorrhoea. The safety and tolerability profile of gepotidacin in the EAGLE-1 trial was consistent with results seen in phase I and II trials. The most commonly reported adverse events in gepotidacin subjects were gastrointestinal. All AEs were mild or moderate except for one severe, unrelated event in each treatment arm and one unrelated serious event in the gepotidacin arm.