Applied Therapeutics Faces Pivotal Week with Key Catalysts Ahead

Investors in Applied Therapeutics are bracing for a potentially transformative period as the biotechnology firm approaches several critical milestones. Currently trading around $1.16, the company's shares could experience significant volatility following Thursday's quarterly earnings release and ongoing regulatory developments surrounding its lead candidate, Govorestat.

All eyes will be on Applied Therapeutics when it reports third-quarter 2025 results on Thursday, November 6. Market analysts project a loss of $0.15 per share for the quarter. While the company demonstrated some resilience last quarter by surpassing expectations by $0.02, the broader financial outlook remains challenging. Current projections indicate anticipated losses of $1.00 per share for both 2025 and 2026.

The company's financial metrics reveal substantial pressures: a negative EBIT margin of 56,283%, a price-to-sales ratio of 666.74, and negative operating income of $21.3 million. With $79.4 million in cash reserves against a market capitalization of $175.69 million, the company operates within tight financial constraints. The stock has demonstrated considerable volatility throughout the year, trading between a 52-week low of $0.30 and a high of $10.62.

Regulatory Crossroads for Govorestat

Beyond quarterly results, the primary catalyst for Applied Therapeutics remains the regulatory pathway for Govorestat in treating CMT-SORD. The company concluded crucial discussions with the FDA in late September, though official meeting minutes remain pending. The central question facing investors is whether the drug candidate will receive accelerated approval, a decision that could dramatically impact the company's valuation.

Should investors sell immediately? Or is it worth buying Applied Therapeutics?

The stock has already experienced substantial swings related to Govorestat's development. Following positive clinical data, shares surged from $0.51 to $1.18, only to retreat after the FDA meeting. This volatility echoes previous regulatory setbacks in late 2024 when Govorestat failed to gain approval for galactosemia treatment.

Institutional Sentiment and Market Positioning

Institutional investors maintain overwhelming control with 98.31% ownership. Marshall Wace LLP notably increased its position by 18.1% during the second quarter. Analyst opinions reflect the company's uncertain position, with a consensus "Hold" rating alongside a price target of $4.13—representing potential upside of 257%. However, these targets date back to May 2025, while current technical indicators suggest bearish momentum.

The coming days will prove decisive for Applied Therapeutics as market participants weigh quarterly performance against regulatory prospects. The company stands at a critical juncture, with potential for either a significant turnaround or continued downward pressure on its valuation.