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Beigene Limited (NASDAQ: BGNE) provided a regulatory update on the anticipated US approval decision for the Biological License Application for tislelizumab in 2L metastatic esophageal squamous cell carcinoma (ESCC).
With the BLA filing initially having a PDUFA date of July 12, the FDA deferred action on the decision, as they have been unable to conduct required inspections in China due to recent COVID-19 travel restrictions.
SVB Leerink notes that BGNE did not receive a Complete Response Letter (CRL), and the application remains under review.
The company indicated that a new action date had not been provided by the FDA, as the public health situation in China continues to evolve.
BGNE and partner Novartis AG (NYSE: NVS) will work closely with the agency to help schedule the inspections when possible.
SVB thinks the reason for the decision may be favorable for some investors, as there has been speculation that the agency may view data from China unfavorably.
"Therefore, the decision to delay the application versus issuing a CRL and terminating the review cycle could be viewed as a positive." the analysts added.
Price Action: BGNE shares are up 2.69% at $174.30 during the market session on the last check Thursday.
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