Applied Therapeutics reported its Q2 2021 financial results, highlighting the advancement of their pediatric Galactosemia program and preparations for NDA submission in Q3 2021. The company ended the quarter with a strong balance sheet, holding $125.6 million in cash and cash equivalents.
NDA submission for AT-007 in Galactosemia expected in Q3 2021.
Commercial preparations are ongoing for the anticipated launch in 2022.
Registrational study in SORD is expected to launch later this year.
Enrollment in ARISE-HF is expected to complete later this year.
The company provided forward-looking statements regarding the timing of NDA submission for AT-007, expansion programs in SORD Deficiency, initiation and completion of clinical trials, and the likelihood of obtaining regulatory approval of product candidates.