Financial PerformanceAnalyst maintains a BUY rating and raises the Price Target to $21, based on expectation for positive ATA3219 data in NHL and Lupus.
Manufacturing And PartnershipsA second third-party manufacturer FUJIFILM Diosynth Biotechnologies (FDB) has recently been approved to manufacture Ebvallo for EMA, supporting the overall manufacturing process.
Regulatory ProgressThe CRL did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data in the BLA, and the FDA did not request any new clinical trials to support approval.