APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
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Applied Therapeutics' stock dropped by 77% following the FDA's issuance of a Complete Response Letter (CRL) for the company's New Drug Application (NDA) for govorestat, a treatment for classic galactosemia.
November 28, 2024 | 4:30 pm
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Applied Therapeutics' stock fell 77% after the FDA issued a CRL for its NDA for govorestat, a drug intended to treat classic galactosemia. This indicates significant regulatory challenges for the company.
The FDA's issuance of a CRL is a major regulatory setback, indicating that the NDA for govorestat is not approvable in its current form. This has led to a significant drop in APLT's stock price, reflecting investor concerns about the company's future prospects and the potential delay in bringing the drug to market.
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