FDA issued second Complete Response Letter (CRL) on January 12, 2026. ALLELE trial data deemed inadequate for approval. BLA resubmission was accepted July 2025 with PDUFA Jan 10, 2026.
⚠️ Not Investment Advice: This information is provided for educational purposes only.
PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on
historical base rates and do not account for drug-specific factors. Always consult a financial advisor
before making investment decisions.
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