Mira is bringing its version of Oxford Cancer Biomarkers' PGx test to the US in the newly launched ToxNav Advantage assay.

The company discussed plans to leverage MRD in drug development during a call to discuss Q4 and full-year 2025 financials.

In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.

The proceeds may in part fund R&D of its product candidates, which include the pan-RAS molecular glue ERAS-0015 and the KRAS inhibitor ERAS-4001.

The firm will conduct a Phase I trial of its KRAS G12D inhibitor in solid tumors and a Phase II trial of its G12C inhibitor plus an ERK1/2 inhibitor in NSCLC.

Otsuka Pharmaceutical, which licensed the antisense oligonucleotide from Ionis, has rights to commercialize it in Europe and Asia.

The firm filed data from the Phase III VIKTORIA-1 trial, which evaluated gedatolisib with fulvestrant with or without a CDK4/6 inhibitor.

CAR031's global reach," including in China, as a potential treatment for liver and other solid tumors, AbelZeta CEO Tony Liu said.

The update is based on data from the FLEX study in patients with HR-positive, HER2-negative early-stage breast cancer.

The companies struck the deal as Atsena prepares to initiate enrollment of a pivotal cohort of its lead program in XLRS.

After JP Morgan, the company is focusing on getting ready to submit a biologics license application to the FDA for miv-cel in ...