Applied Therapeutics (NASDAQ:APLT) has encountered a tempestuous reckoning as its stock plummeted 30% in the after-hours trading on Thursday. The startling nosedive followed the revelation of a cocktail of news surrounding the disheartening results from a Phase 3 study of its cardiac drug AT-001, coupled with the company’s intention to scout for a partner for the embattled product.
The clinical trial had been painstakingly appraising the drug’s efficacy in mitigating the plight of patients suffering from diabetic cardiomyopathy, specifically those at severe risk of cascading into overt heart failure. Alas, the unveiled data from the investigative scrutiny discerned no discernible statistical divergence in the advancement or steadiness of cardiac functional capacity between patients administered with the medication and those receiving a placebo.
Despite this setback, a tinge of solace was furnished as the data did unearth the drug’s capacity to stabilize cardiac functional capability in a subset of patients abstaining from SGLT2 or GLP-1 drugs for diabetes treatment, as outlined by the company.
Faced with this adversity, the company outlined its strategy to chart a new course for the embattled drug through a strategic alliance, signaling its resolve to channel its finite resources toward the development of another crucial drug candidate, govorestat.
Notably, just a day earlier, Applied Therapeutics had announced its submission of a New Drug Application to the FDA for govorestat in December, marking its foray into the treatment landscape of classic galactosemia.