The OVATION-3 trial is designed to provide an early readout in HRD and BRCA1/2-mutated ovarian cancer patients, ideally leading to rapid filing and approval.

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.