Shots:

• The company has received the FDA’s CRL declining the approval of Vicineum’s BLA to treat BCG-unresponsive NMIBC
• The FDA has provided recommendations to conduct additional clinical/statistical data and analyses of roxadustat in addition to CMC issues related to a recent pre-approval inspection and product quality
• The company plans to meet with the FDA as soon as possible to discuss the next steps for regulatory approval. Additionally- the therapy is currently in a P-III registration trial in the US for the treatment of BCG-unresponsive NMIBC

Ref: Businesswire | Image: Businesswire