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.

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.

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

In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.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 update is based on data from the FLEX study in patients with HR-positive, HER2-negative early-stage breast cancer.

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

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

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

The company is restarting its solid tumor program with the Phase I trial after the company paused it to focus on blood cancer.

The firm reported positive results this week from a biomarker analysis in a Phase IIb trial of OST-HER2, which it will submit to regulators.

The announcement comes on the heels of promising preliminary Phase II data, in which OCU410 reduced lesion growth in patients' eyes.

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