Shares of Applied Therapeutics (APLT, Financial) surged 66.55% today following a significant announcement from the U.S. Food and Drug Administration (FDA). The FDA revealed that a previously scheduled Advisory Committee meeting to review the New Drug Application (NDA) for govorestat in treating galactosemia is no longer required. This boosts the likelihood of FDA approval for the drug, which has its PDUFA date set for November 28, 2024.
Applied Therapeutics Inc. (APLT, Financial) is a clinical-stage biopharmaceutical company headquartered in New York, USA. The company focuses on developing a pipeline of novel product candidates against validated molecular targets for indications of high unmet medical need. Their pipeline includes compounds such as AT-007 for the treatment of rare metabolic diseases like galactosemia and Sorbitol Dehydrogenase (SORD) Deficiency, AT-001 for diabetic cardiomyopathy, and AT-003 for diabetic retinopathy.
As of today, APLT trades at $7.74 per share. Despite the recent surge, the stock still has several financial weaknesses. The Altman Z-score of -3.67 indicates financial distress, suggesting a potential bankruptcy risk within the next two years. Furthermore, the Piotroski F-Score of 3 signifies poor business operation, and the Sloan Ratio at -143.09% reflects poor quality of earnings predominantly made up of accruals.
On the positive side, APLT holds a comfortable interest coverage ratio, meaning the company has sufficient cash to cover its debt obligations. This provides some stability in its financial situation.
From a valuation perspective, the company's Price-to-Book (P/B) ratio stands at 12.29, which is relatively high compared to its peers. The GF Value provides no specific valuation for APLT, indicating that it cannot be evaluated through the GF Value method.
In terms of market performance, the stock has seen a year-to-date increase of 38.81% and a 52-week price range that oscillates between $1.79 and $9.39. This highlights the volatility inherent in investing in clinical-stage biopharmaceutical companies like APLT.
Investors should keep an eye on the next earnings report estimated on November 8, 2024, as well as the upcoming FDA decision on govorestat, which will be pivotal for the future trajectory of APLT's stock price.
