The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical ...

While Applied Therapeutics has vowed to reapply or appeal the FDA’s recent rejection of its rare disease candidate govorestat ...

Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat ...

Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...

The pharma company's shares are getting crushed after regulators decline to green light a drug to treat a rare disease.

NEW YORK, NY / ACCESSWIRE / December 4, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Applied ...

Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...

Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, ...

This sharp decline in the company’s stock raises several questions about its future prospects, especially given the positive momentum it had been building throughout the year. Let’s delve into what ...

Leerink Partners analyst Joseph Schwartz has maintained their bullish stance on APLT stock, giving a Buy rating on November 29.Don't Miss our ...

The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.