APLT Stock Forecast & Price Target

Applied Therapeutics Inc. is experiencing a positive shift in market sentiment, particularly following the cancellation of an Advisory Committee meeting, which has led to predictions of a potential stock increase and an implied market capitalization of approximately $2.0 billion. The company's commitment to developing novel therapies, specifically for conditions like Galactosemia and Sorbitol Dehydrogenase deficiency, has seen an increase in the probability of success (PoS) ratings, improving from 70% to 85% for govorestat treatments. Additionally, the anticipated regulatory flexibility from the FDA and strong clinical outcomes, including significant reductions in galactitol and improvements in various metrics, further underscore a promising outlook for the company's pipeline.

The financial outlook for Applied Therapeutics Inc is negatively impacted by uncertainties surrounding regulatory approvals for its lead candidate, govorestat, particularly in regard to SORD and galactosemia, with potential market cap implications of approximately $300 million if the FDA issues a complete response letter (CRL). Additionally, the company's core business and product sales may fail to meet expectations, and the risk of disappointing pipeline candidates could further diminish stock value. Concerns about data integrity raised by the FDA's recent Warning Letter further heighten the risks associated with the company's developmental path, potentially leading to significant declines in share value.