Andexxa10/22/2023 “We expect AndexXa to receive EU approval in 1Q19. The analysts maintained their Outperform rating and US$80 price target on Portola Pharmaceuticals. “We forecast AndexXa peak sales of US$1.25bn in 2029 based on 50% penetration of 85K patients in the US on Factor Xa inhibitors with life-threatening or uncontrolled bleeding and generic erosion beginning in 2030,” wrote the analysts. The analysts said Ciraparantag which has been in development since 2013 “still has more clinical work ahead” before contemplating regulatory submissions. “As the only approved reversal agent for Xarelto and Eliquis, we believe AndexXa should remain relatively free of competitors for some time based on ciraparantag's: 1) seemingly inferior efficacy, 2) potential safety concerns, and 3) apparent dosing issues,” wrote the Oppenheimer analysts. The analysts expect a Ph3 study to be required for regulatory purposes, potentially with AndexXa as an active comparator versus ciraparantag. READ: Portola Pharmaceuticals has 3 'differentiated assets' with strong potential, says Oppenheimer Both studies have primary completion in July. It is in separate Ph2 studies for the reversal of Xarelto and Eliquis. Perosphere Pharmaceuticals Inc.’s Ciraparantag is the only potential competitor to AndexXa currently in clinical development. the NBI and S&P 500 both up 4% YTD), we explore one of the bear theses we consider potentially misleading,” wrote Oppenheimer analysts Jay Olson and Silvan Tuerkcan in a research note released Thursday. “With Portola shares down 16% YTD despite FDA approval of AndexXa on May 4 (vs. In May, AndexXa became the first and only antidote for life-threatening or uncontrolled bleeding in patients taking blood thinners made with rivaroxaban and apixaban. Analysts at Oppenheimer debunked the idea that there was any serious competitive threat to Portola Pharmaceuticals Inc.’s ( NASDAQ:PTLA) bleeding antidote AndexXa.
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