Applied Therapeutics up after details posted for confirmatory govorestat study

Applied Therapeutics (APLT) shares have advanced after the clinicaltrials.gov website was updated to show details about a planned confirmatory trial designed to assess the long-term efficacy and clinical benefit of AT-007 in patients with CMT-SORD, a rare genetic disorder. The international, multi-center, randomized, double-blinded, placebo-controlled, Phase 3 study is designed to assess the efficacy and clinical benefit of long-term govorestat administration to patients with CMT-SORD utilizing functional, patient-reported, and clinical outcomes measures including the CMT-HI, 10MWRT, dorsiflexion, the CMT-FOM, and CMT-related lower extremity muscle MRI parameters along with the long-term effect of govorestat on whole blood sorbitol, according to the posting. Long-term safety of govorestat will also be evaluated, the site noted. Baird analyst Brian Skorney says the listing “could imply” that the company’s Q3 meeting with FDA “went well as the classification of a study as ‘confirmatory’ vs. ‘pivotal’ implies that the drug could have Subpart H approval by the time it reads out.” In afternoon trading, shares of micro-cap Applied are up 40c, or 71%, to 96c.