- Beigene Limited 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 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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