Applied Therapeutics Stock Rises as FDA Clears Path for Drug

Positive Momentum for Applied Therapeutics Stock

Applied Therapeutics, Inc. has recently seen a significant spike in its stock, with a remarkable increase in trading volume. On a recent trading session, the company’s shares went up with a noteworthy volume of 31.75 million shares changing hands, far surpassing the average volume of 1.26 million.

Update on New Drug Application

The recent surge follows the company’s announcement regarding its ongoing New Drug Application (NDA) review for govorestat, a potential treatment for Classic Galactosemia. This inherited metabolic disorder prevents the body from effectively processing galactose, a simple sugar.

FDA Guidelines and Expectations

In a groundbreaking development, the company recently concluded a late-cycle review meeting with the FDA. The agency announced that it would no longer require an Advisory Committee meeting that was tentatively scheduled for an upcoming date. Instead, they confirmed that the Priority Review of the NDA would continue on track, with discussions surrounding post-marketing requirements expected to take place in the future.

Upcoming Action Dates

Additionally, the Prescription Drug User Fee Act (PDUFA) target action date for this review remains unchanged and is set for the end of November. This maintains the momentum towards potentially launching a critical treatment in the near future.

Anticipated Launch and Market Potential

Financial analysts, including those from William Blair, forecast that Applied Therapeutics might launch govorestat in the galactosemia market by 2025. The expectation is high due to a significant unmet medical need in this area, as well as the absence of approved therapies currently available.

Sales Projections

Analysts predict that sales for govorestat could exceed $1 billion by 2030 if the company captures about 70% of market penetration in the galactosemia sector. This presents an exciting opportunity for investors as the company advances its innovative therapies.

Stock Performance Overview

As of the latest check, Applied Therapeutics saw its stock price increase significantly. The shares were noted to be up by 71.40%, reaching a price point of $7.97. This upward trend reflects the positive investor sentiment bolstered by the FDA's supportive stance on the company's new drug application.

Conclusion

The increasing interest in Applied Therapeutics and its innovative product for Classic Galactosemia highlights a pivotal evolution within the biotech sector. With an FDA review progressing smoothly and a strong market potential, there is growing optimism surrounding the company's future prospects.

Frequently Asked Questions

What triggered the increase in Applied Therapeutics stock?

The stock surged following the announcement from the FDA that an Advisory Committee meeting would not be necessary for the review of govorestat, coupled with a substantial increase in trading volume.

What is govorestat developed for?

Govorestat is designed to treat Classic Galactosemia, an inherited metabolic disorder that hinders the body's ability to process galactose.

When is the PDUFA target action date for govorestat?

The target action date set under the Prescription Drug User Fee Act is scheduled for November 28.

What are the market expectations for govorestat?

Analysts predict that govorestat could see sales exceeding $1 billion by 2030, capturing approximately 70% of the market in galactosemia.

What was the recent stock price for APLT?

Recently, APLT stock was reported to be trading at $7.97, reflecting a significant increase of 71.40%.

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