11:35 AM EDT, 05/13/2024 (MT Newswires) -- A Type C meeting with the Food and Drug Administration in the coming few weeks will establish registrational pathway for Oncolytic Biotech's pelareorep in HR+/HER2- metastatic breast cancer, notes RBC.
Following discussions with the clinical advisors, collaborators, and potential partners over the last year, Oncolytics aims to conduct an "efficiently sized," cost-effective, randomized, controlled study that with positive data could lead directly to a registrational filing or to substantially de-risking a subsequent Phase 3 study, analyst Douglas Miehm writes.
Management reaffirmed the OS data readout from the BRACELET-1 trial in H2/24. The company also received approval from the German regulator to begin enrolling patients in a new pancreatic cancer cohort.
RBC is reiterating its positive outlook for Oncolytics, with an Outperform/speculative risk rating and $6 target