The regulator is allowing the firm to submit data on 4D-150 from a single Phase III trial and draw on readouts from previously conducted studies in wet AMD.

In a retrospective analysis of patients who received peptide vaccines via n-of-1 programs, 89 percent had immune reactions.

The FDA granted priority review to the application and will decide whether to approve the treatment by Dec. 5.

The firm will evaluate the drug's safety and early efficacy in patients with advanced AKT1 E17K-mutant solid tumors.

The firm will continue developing Lava's two partnered bispecific gamma delta T-cell engager programs with Pfizer and Johnson & Johnson.

Under Project Impact, one of four programs backed by $200 million in funds, researchers aim to harmonize EHR data and build an AI model to improve cancer care.