ImmunityBio refusal to file letter ‘surprising,’ says H.C. Wainwright

H.C. Wainwright analyst Andres Maldonado keeps a Buy rating on ImmunityBio (IBRX) after the company received a “surprising” refusal to file letter from the FDA regarding its supplemental applicating for Anktiva plus Bacillus Calmette-Guerin in BCG-unresponsive non-muscle invasive bladder cancer patients with papillary-only disease. The letter came despite prior, unanimous agency guidance in January encouraging the company to proceed with the filing, the analyst tells investors in a research note. The firm says that while the letter can be addressed, it does extend timelines for Anktiva in the papillary NMIBC setting. “Many questions remain,” according to H.C. Wainwright.