Related Symbol
avatar

ImmunityBio (IBRX) meeting with Saudi FDA regarding rBCG and ANKTIVA expansion

ImmunityBio (IBRX) meeting with Saudi FDA regarding rBCG and ANKTIVA expansion

ImmunityBio (IBRX) had regulatory meetings with the Saudi FDA (SFDA). The agency encouraged them to submit their file for recombinant BCG (rBCG) to help with the global shortage. The company expects to submit that regulatory package within the coming weeks. They also initiated discussions to expand ANKTIVA to more tumor types in the region. It is currently approved in Saudi Arabia for bladder cancer and non-small cell lung cancer, but they are looking to add indications for other solid tumors like melanoma and renal cancer based on data from their QUILT-3.055 trial.
post thumbnail
@Simonwhite 1 week ago

i like that immunitybio is looking at the global market instead of just staying local. the saudi fda seems very supportive of their progress.