With an FDA IND clearance, the firm will test IKS014 as an alternative for HER2-positive solid tumor patients in the US who have relapsed on other therapies.

The firms are planning two clinical trials of the anti-CTLA-4 agent muzastotug in colorectal cancer and in solid tumors.

As part of the deal, AbbVie will acquire Capstan's targeted LNP platform technology and its lead candidate for B cell-mediated autoimmune diseases.

The firm is advancing its AI-driven multi-modal digital pathology platform as a tool for guiding clinical trial design and patient identification.

The approval in the second-line EGFR- and MET-altered setting was based on results from the SACHI trial, which compared Orpathys and Tagrisso against chemo.

The company is developing treatments for autism and substance use disorders tailored to patient subgroups identified by clinico-genomic signatures.

The firm will take a different reimbursement strategy for the test than its prior owner Biocept, which stopped selling it after filing for bankruptcy in 2023.

The agency will allow BMS to discontinue REMS programs for both therapies and reduce certain patient monitoring requirements.

The company said the therapy is the first allogenic therapy developed with its Tmod technology to be tested in humans.

The firm hopes to overcome common dose-limiting toxicities with its PSMA-targeted radiotherapy while boosting potency versus competitors.

The company established a new protocol for the study and will advance its drug response predictor as a companion diagnostic.