Baird analyst Brian Skorney raised his price target on Applied Therapeutics to $43 from $24 following the release of its positive top-line data on adults with galactosemia. He raised his probability of success for AT-007 in galactosemia from 20% to 50%. Skorney reiterated his Outperform rating on Applied Therapeutics shares.
Citi analyst Yigal Nochomovitz raised his price target for Applied Therapeutics to $44 from $29 saying he continues to see upside following the pivotal galactosemia data for AT-007. AT-007 now demonstrated activity in galactosemia patients, and the statistically significant 50% reduction in key biomarker plasma galactitol is sufficient for Applied to file for regulatory approval, Nochomovitz tells investors in a research note. The analyst keeps a Buy rating on the shares.
What caused the price target hikes is that on January 8, 2020, Applied Therapeutics Inc. (Nasdaq:APLT) announced positive topline results from the Pivotal Phase 2 portion of the ACTION-Galactosemia study of AT-007, a central nervous system (CNS) penetrant Aldose Reductase inhibitor, in adult Galactosemia patients. ACTION-Galactosemia is a double-blind placebo-controlled trial evaluating safety and pharmacokinetics of AT-007 in healthy volunteers, as well as safety, pharmacokinetics, and biomarker effects in adult Galactosemia patients over 28 days of once daily oral dosing. The key biomarker outcome of the study was reduction in galactitol, an aberrant toxic metabolite of galactose, formed by Aldose Reductase in Galactosemia patients.
AT-007 treatment resulted in a statistically significant and robust reduction in plasma galactitol vs placebo in adult Galactosemia patients. Reductions in galactitol were dose dependent, with higher concentrations of AT-007 resulting in a greater magnitude of reduction in galactitol. At the highest dose tested (20mg/kg), AT-007 significantly reduced plasma galactitol 45-54% from baseline vs. placebo (p<0.01). Galactitol reduction was rapid and sustained over time. No substantial change from baseline was observed in placebo treated patients. AT-007 was well tolerated, with no drug-related adverse events noted to date in Galactosemia patients or in the 72 healthy volunteers treated in Part 1 of the trial.
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