FDA Seeks Further Safeguards for AstraZeneca's Ultomiris Therapy, But Efficacy Not in Question
Portfolio Pulse from Vandana Singh
The FDA has issued a complete response letter (CRL) to AstraZeneca regarding its supplemental Biologics License Application for Ultomiris therapy for neuromyelitis optica spectrum disorder (NMOSD). The FDA did not question the efficacy or safety data from the trial but requested modifications to enhance the Ultomiris Risk Evaluation and Mitigation Strategy (REMS). AstraZeneca's shares are down 0.78% in premarket trading.
September 06, 2023 | 11:51 am
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NEGATIVE IMPACT
AstraZeneca's shares are down 0.78% in premarket trading following the FDA's request for further safeguards for its Ultomiris therapy.
The FDA's request for further safeguards for AstraZeneca's Ultomiris therapy could potentially delay its approval, which may have led to the decrease in AstraZeneca's share price. However, the FDA did not question the efficacy or safety data from the trial, which could limit the negative impact on the stock price.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100