ImmunityBio (IBRX) shares jumped past 18% in recent Thursday trading after it provided an update on its ongoing discussions with the US Food and Drug Administration regarding its cancer pipeline and submissions of marketing authorization applications in Europe and the UK.
Late Wednesday, the company said it is eying to submit a supplemental biologics license application this year for its treatment targeting Bacillus Calmette-Guerin unresponsive non-muscle invasive bladder cancer or NMIBC in the papillary indication.
The company said it also plans a regulatory submission for an alternative source of BCG in Q1 and to submit a BLA this year for second- and third-line treatment of patients with non-small cell lung cancer.
In a separate statement late Wednesday, the company said it completed the submissions of its marketing authorization applications in the EU and the UK for Anktiva plus BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors.
ImmunityBio said it is responding to requests for information from the EU's European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency, with the potential of approval by next year.
Price: 2.83, Change: +0.44, Percent Change: +18.20
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