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The future discussions with the FDA and the potential NDA review for the treatment of SORD deficiency are crucial next steps for Applied Therapeutics (NASDAQ:APLT). The outcome of these events will be closely watched by investors and could significantly influence the company's trajectory in the coming year.
With a market capitalization of nearly $1 billion and a FAIR overall financial health score from InvestingPro, the company's fundamentals will be key to monitoring its progress through these regulatory challenges. With a market capitalization of nearly $1 billion and a FAIR overall financial health score from InvestingPro, the company's fundamentals will be key to monitoring its progress through these regulatory challenges.
The future discussions with the FDA and the potential NDA review for the treatment of SORD deficiency are crucial next steps for Applied Therapeutics. The outcome of these events will be closely watched by investors and could significantly influence the company's trajectory in the coming year. With a market capitalization of nearly $1 billion and a FAIR overall financial health score from InvestingPro, the company's fundamentals will be key to monitoring its progress through these regulatory challenges.
The firm remains optimistic about the company's prospects, despite the setback. The analyst believes that the approval process for SORD deficiency under Subpart H, which allows for accelerated approval for certain drugs, may be more straightforward than obtaining full approval for galactosemia. Based on this, Baird anticipates that Applied Therapeutics could likely secure approval for the SORD deficiency treatment in 2025.
Applied Therapeutics has not publicly detailed how the FDA review process failed to meet approval criteria. This lack of clarity poses a significant hurdle for the company as it moves forward with its pipeline. The FDA's decision has raised concerns about the company's ability to recover from this setback.
The future discussions with the FDA and the potential NDA review for the treatment of SORD deficiency are crucial next steps for Applied Therapeutics. The outcome of these events will be closely watched by investors and could significantly influence the company's trajectory in the coming year.
In other recent news, Applied Therapeutics faced a downgrade from RBC Capital Markets from Outperform to Sector Perform. The repositioning follows the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the firm's drug govorestat, intended for the treatment of galactosemia. Despite the setback, the company is seen to hold potential in its SORD deficiency program, with an anticipated New Drug Application (NDA) submission in the first quarter of 2025.
Further, Applied Therapeutics intends to discuss potential resubmission or appeal options with the FDA for govorestat. The drug has demonstrated improvements in cognitive and behavioral outcomes in pediatric patients during clinical trials, despite the FDA's recent decline of approval due to clinical application deficiencies.
On the financial front, Applied Digital Corporation reported a fiscal first quarter revenue of $60.7 million, marking a 67% increase year-over-year. The company's adjusted net loss was $21.6 million or $0.15 per share, which was better than the anticipated loss of $0.27 per share. Adjusted EBITDA stood at $20.0 million, a significant increase from the previous year.
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