Keep an eye on beaten-down shares of Applied Therapeutics (SYM: APLT).
After dropping from about $6.50 to $4.65, it appears to have caught strong support at its 200-day moving average and is starting to pivot. Helping, the company just provided a regulatory update on its treatment of classic galactosemia, a disorder that impacts how the body processes a simple sugar called galactose.
According to its latest press release, “The company completed its late-cycle review meeting with the FDA, which no longer intends to hold an Advisory Committee meeting. The FDA’s review of the New Drug Application (NDA) continues as planned, with the PDUFA target action date set for November 28, 2024.”
“The FDA communicated that the Priority Review of the NDA is proceeding as scheduled, with alignment on post-marketing requirements expected in October 2024. Applied Therapeutics expressed satisfaction with the ongoing collaborative dialogue with the FDA and remains committed to bringing the first potential treatment to Classic Galactosemia patients.”
