Oncolytics Biotech

Oncolytics Biotech has announced a "Type D" meeting with the FDA for early August to discuss adding a randomized part B to the REO 033 study, intended to support both accelerated and full approvals for pelareorep. Part B would retain the existing study design, increase the number of participants and incorporate a blinded independent central review to generate randomized efficacy data without starting a separate trial. The company reports progress in part A (target: 60 patients): about half of the sites are expected to be activated by the end of July and more than 20 patients have been pre-identified; full site activation is planned by the end of August. Oncolytics expects a first tumor response update from part A by the end of 2026 and, subject to FDA feedback, aims to begin recruitment for part B in the first quarter of 2027. » Altro su de.investing.com

Oncolytics has set a Type C meeting with the FDA for April 16 to discuss a registration‑relevant, single‑arm study plan for pelareorep plus a checkpoint inhibitor in squamous cell carcinoma of the anus in second‑line and later therapy. The planned study would include around 60–70 patients with objective response rate (ORR) as the primary endpoint; earlier data (GOBLET cohort 4) showed an ORR of ~30% with a median duration of response of 17 months versus real‑world rates of 10–14%. The company has a market capitalization of USD 111.52 million, reported a negative free cash flow of USD 26.48 million over the past twelve months, and is given a weak financial rating by InvestingPro. » Altro su de.investing.com

Oncolytics Biotech has completed the first part of its planned relocation and moved its jurisdiction of incorporation from Alberta to British Columbia via a process described as a “continuance.” The common shares, company name and NASDAQ trading symbol remain unchanged; the CUSIP and ISIN will remain the same until the completion of the second phase. Shareholders approved the move on January 15, 2026; the second phase foresees a transfer to Nevada effective March 31, 2026, after which the CUSIP and ISIN will change and outstanding shares will be converted into U.S. par value shares. The company adopted new articles of incorporation in British Columbia that differ in part from its previous founding documents. » Altro su de.investing.com