Applied Therapeutics (NASDAQ:APLT) is now navigating a critical period as it engages with the FDA for its upcoming NDA review in SORD deficiency, with the hopes of securing an approval that could potentially bolster the company's position following the recent setback.
One positive note from InvestingPro analysis shows the company holds more cash than debt on its balance sheet, providing some financial flexibility during this challenging period. The next earnings report is expected on March 14, 2025, which could provide crucial updates on the company's regulatory progress.
One positive note from InvestingPro analysis shows the company holds more cash than debt on its balance sheet, providing some financial flexibility during this challenging period. The next earnings report is expected on March 14, 2025, which could provide crucial updates on the company's regulatory progress.
Applied Therapeutics is now navigating a critical period as it engages with the FDA for its upcoming NDA review in SORD deficiency, with the hopes of securing an approval that could potentially bolster the company's position following the recent setback.
One positive note from InvestingPro analysis shows the company holds more cash than debt on its balance sheet, providing some financial flexibility during this challenging period. The next earnings report is expected on March 14, 2025, which could provide crucial updates on the company's regulatory progress.
Despite the hurdles faced with the galactosemia drug, Baird's analyst remains optimistic about the company's prospects for its treatment for SORD deficiency.
The analyst believes that the approval process for SORD deficiency under Subpart H, which allows for accelerated approval for drugs treating serious conditions, might not require as much flexibility from the FDA as a full approval for the galactosemia treatment. According to the analyst, the likelihood of obtaining approval for the SORD deficiency treatment in 2025 is more probable than not.
Applied Therapeutics is now navigating a critical period as it engages with the FDA for its upcoming NDA review in SORD deficiency, with the hopes of securing an approval that could potentially bolster the company's position following the recent setback.
In other recent news, Applied Therapeutics has been the subject of recent analyst downgrades. Baird has cut the company's stock target, while RBC (TSX:RY) Capital Markets has downgraded the stock from Outperform to Sector Perform. Despite these adjustments, both firms see potential in the company's SORD deficiency program.
Applied Therapeutics has been in discussions with the FDA regarding the potential NDA review for the treatment of SORD deficiency. These developments are being closely monitored by investors as they could significantly influence the company's trajectory. The company also intends to discuss potential resubmission or appeal options with the FDA for its drug govorestat, which recently failed to meet approval criteria for the treatment of galactosemia.
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. These are among the recent developments in the companies.
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