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Benzinga
3 days

Regulatory Setback For Applied Therapeutics' Lead Program, FDA Highlights Deficiencies In Clinical Application

1. FDA issued a Complete Response Letter for APLT's govorestat NDA. 2. Deficiencies in clinical application cited, delaying potential approval and launch. 3. William Blair downgraded success probability for galactosemia to 30%. 4. SORD program remains unaffected; potential revenue by late 2025 possible. 5. APLT stock dropped 67.2% following the FDA's decision.

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FAQ

Why Very Bearish?

The CRL significantly impairs approval timeline, similar past reactions saw deeper declines.

How important is it?

Article outlines a critical setback which directly impacts APLT's viability and investor perception.

Why Long Term?

Approval delays may affect long-term revenue projections, akin to other biotech cases.

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