On Wednesday, Applied Therapeutics, Inc. (NASDAQ:APLT) stock traded higher with a session volume of 31.75 million, compared to an average volume of 1.26 million, according to data from Benzinga Pro.
The company announced an update on the ongoing New Drug Application (NDA) review of govorestat for Classic Galactosemia.
Galactosemia is an inherited metabolic disorder that makes the body unable to process a sugar called galactose.
Also Read: Why Is Rare Disease-Focused Applied Therapeutics Stock Trading Higher Today?
The company recently completed its late-cycle review meeting with the FDA, and the agency communicated that an Advisory Committee meeting, previously tentatively scheduled for October 9, would no longer be required.
The FDA informed the company that the Priority Review of the NDA is continuing as planned, with alignment on post-marketing requirements expected in October 2024.
The previously announced Prescription Drug User Fee Act (PDUFA) target action date remains on track for November 28.
In April, the FDA extended the review period for Applied Therapeutics’ marketing application, seeking approval for its potentially first marketed drug govorestat (AT-007) for Classic Galactosemia, by three months.
William Blair anticipates that Applied Therapeutics will launch govorestat in the galactosemia market in 2025, predicting a successful rollout due to the high unmet medical need, absence of other approved therapies, well-identified patient population, and the strong performance of first-in-class rare disease products.
The analyst estimates 2030 sales of govorestat to exceed $1 billion with 70% peak penetration in the galactosemia market.
Price Action: At last check on Wednesday, APLT stock was up 71.40% at $7.97.
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This article Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic Disorder Drug originally appeared on Benzinga.com
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