This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
Full approval will depend on verification of clinical benefit in a confirmatory trial
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements
The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
GS-098, a first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor, is designed to rapidly block the pathogenic activity of thyroid-stimulating autoantibodies
The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies
The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first
Adverse events were similar to placebo, and no AP-101-induced antibody responses were detected
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