ImmunityBio received an FDA "refusal to file" letter for its application to expand Anktiva's use in bladder cancer patients, causing a 25% stock plunge and prompting calls for agency clarification.
ImmunityBio has executed a $75 million registered direct offering with a single institutional investor, providing crucial working capital for its ongoing operations.
A second-generation BCMA-directed CAR T-cell therapy, MDC-CAR-BCMA001, demonstrated remarkable efficacy in patients with relapsed/refractory multiple myeloma and AL amyloidosis, achieving a 5/6 overall response rate with 4 complete responses.
ImmunityBio reports significant progress with ANKTIVA's approval and permanent J-code assignment for treating BCG-unresponsive bladder cancer CIS, marking a major advancement in treatment options.
Verastem Oncology will present additional analyses from the Phase 2 RAMP 201 trial evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer at SGO 2025, building on their FDA Priority Review submission.
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