FDA Meeting Set for August as Colorectal Cancer Trial Hits Key Milestones
ONCY sits 21% above its 52-week low of $0.77.
Summary
Oncolytics announced rapid site activation in its randomized colorectal cancer trial, with half of planned sites opening this month and over 20 patients pre-identified. The company will hold a Type D meeting with the FDA in August to discuss adding a registrational Part B to the study, designed to support both accelerated and full approval. This follows the April FDA alignment on the pivotal study design and the highly positive REO 022 data in May. The operational progress and clear regulatory pathway reduce development risk and could significantly shorten the timeline to market. Initial tumor response data from Part A is expected by year-end 2026, with Part B enrollment potentially starting in Q1 2027.
At the time of this announcement, ONCY was trading at $0.93 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $105.9M. The 52-week trading range was $0.77 to $1.51. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.