Eli Lilly & Co. said Thursday it received a complete response letter (CRL) from the U.S. Food and Drug Administration regarding its Biologics License Application (BLA) for its treatment for non-small cell lung cancer. The CRL says the FDA can’t approve the BLA for sintilimab in its present form, and includes a recommendation for an additional clinical study. The drug maker is assessing the next steps for sintilimab in the U.S. Lilly’s stock, which was still inactive in premarket trading, has gained 4.1% over the past three months while the S&P 500 has declined 5.7%.
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