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Fly News Breaks for May 26, 2016
GSK, IONS
May 26, 2016 | 13:38 EDT
Leerink analyst Michael Schmidt remains cautious on Ionis Pharmaceuticals (IONS) after GlaxoSmithKline (GSK) decided not to initiate the planned Phase III trial ofIONS-TTR-Rx in patients with TTR amyloid cardiomyopathy. The analyst believes the severe thrombocytopenia events "clearly increase the risk" around the Ionis platform. He notes that the TTR program currently reflects 36% of his valuation for the company. Schmidt keeps a Market Perform rating on Ionis with the stock down 39% to $21.44.
News For IONS;GSK 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.