Applied Therapeutics Surges 124% in a Month: Here's Why

Applied Therapeutics, Inc. a clinical-stage company, is currently focused on developing novel therapies against rare neurological, cardiac and ophthalmic disorders where there are high unmet medical needs.

The company’s lead candidate is govorestat (also known as AT-007), a novel central nervous system penetrant ARI, which is being developed for three rare neurological diseases at present, including galactosemia, sorbitol dehydrogenase (SORD) deficiency and phosphomannomutase 2 deficiency.

Apart from govorestat, Applied Therapeutics’ pipeline comprises two other investigational candidates, namely AT-001 for the treatment of diabetic cardiomyopathy (a fatal fibrosis of the heart) and AT-003 for the treatment of diabetic retinopathy.

In the past month, shares of APLT have skyrocketed 124.3% compared with the industry’s 2.9% growth, fueled by encouraging regulatory/developmental updates from the developmental programs for govorestat to treat galactosemia and SORD deficiency.

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The upward stock price movement was triggered around mid-February when Applied Therapeutics announced positive interim 12-month results from its ongoing phase III INSPIRE registrational study of govorestat for the SORD deficiency indication. Per the data readout, the late-stage study achieved its clinical efficacy and pharmacodynamic biomarker primary endpoints, along with several key secondary endpoints, at the end of 12 months.

The INSPIRE study is evaluating the efficacy of once-daily oral govorestat in 56 patients aged 16-55 years with SORD deficiency in the United States and the EU.

Applied Therapeutics believes that the encouraging 12-month interim analysis data confirm the role of sorbitol as a key driver of disease severity and progression over time. The company will again read out data from the phase III INSPIRE study at 24 months, with the 10-meter walk-run test as its primary clinical efficacy endpoint.

Presently, given the urgent need for treatment and the absence of any other options, management is planning to meet with the FDA to discuss the potential of a regulatory filing for govorestat to treat SORD deficiency based on the results from the 12-month interim analysis of the INSPIRE study.

In late February, APLT announced that the FDA accepted its approval-seeking application for govorestat to treat classic galactosemia under its Priority Review pathway. This further boosted the stock price.

A filing designated as a Priority Review reduces the review period by four months. A final decision from the regulatory body is expected on Aug 28, 2024. The regulatory body has also reported that it will hold an advisory committee meeting to discuss the application.

Subject to approval, govorestat would be the first medication indicated for the treatment of galactosemia and Applied Therapeutics’ first commercial product.

A regulatory filing for govorestat to treat classic galactosemia is also currently under review in the EU. The company expects a decision by the EU regulatory body in the fourth quarter of 2024.

Applied Therapeutics Inc. Price and Consensus

Zacks Rank and Stocks to Consider

Applied Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the drug/biotech industry are ADMA Biologics，FibroGen，and Adicet Bio, Inc.While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ACET carry a Zacks Rank #2 (Buy) each at present.

In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past month, shares of ADMA have gained 16.7%.

ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.

In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past month, shares of the FGEN have lost 16%.

FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.

In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has widened from $1.80 to $1.81. In the past month, shares of ACET have lost 18.6%.

ACET beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.

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