$ONCY

ONCOLYTICS BIOTECH INC (ONCY) filed an SEC Form 8-K — Other Events. Oncolytics Biotech ® Announces Publication Demonstrating Pelareorep Creates Immune Responses in Liver Cancer That Make Tumors Susceptible to Immunotherapy Data support pelareorep’s potential as a backbone therapy to transform immunologically inactive liver tumors into a phenotype

Oncolytics Biotech (Nasdaq: ONCY) announced data published in the Proceedings of the National Academy of Sciences showing pelareorep can alter the tumor microenvironment in liver cancer, making it susceptible to immunotherapy. The study demonstrated increased PD-L1 expression, ICOSL levels, and CD8+ T cell density. Oncolytics is developing pelareorep for metastatic gastrointestinal cancers and is pursuing strategic partnerships.

ONCOLYTICS BIOTECH INC (ONCY) filed an SEC Form 8-K — Other Events. Oncolytics Biotech ® Reports Accelerating Enrollment in Randomized REO 033 RAS-Mutant, MSS Colorectal Cancer Study Substantially all planned REO 033 clinical sites are now activated, with multiple patients currently on study Company expects to have sufficient Part A data to provi

Oncolytics Biotech (ONCY) reported positive preclinical results for pelareorep combined with a pan-RAS inhibitor in colorectal cancer. The combination reduced tumor growth, with the greatest reductions in the RAS inhibitor and combination groups. The company plans to expand preclinical evaluation, aiming to characterize pelareorep's impact on tumor response and resistance development. Pelareorep is an investigational immunotherapy with a dual mechanism of action.

Oncolytics Biotech (ONCY) said the U.S. FDA provided written feedback aligning the registrational path for its REO 033 study of pelareorep in second-line RAS-mutant, MSS metastatic colorectal cancer. The FDA supports expanding into a pivotal Part B, with accelerated approval possible via ORR and DoR, and PFS for full approval. ONCY plans an End-of-Phase 2 meeting. Shares trade at $0.83.

Oncolytics Biotech (NASDAQ:ONCY) received FDA Fast Track for pelareorep plus a checkpoint inhibitor in 2L+ squamous cell anal cancer, citing GOBLET results of about 30% ORR, 15.5-month DOR, and 82% 12-month OS. Separately, ONCY received a Nasdaq notice for trading below the $1.00 minimum bid for 30 business days and must regain compliance by Jan 19, 2027.

The FDA granted fast track designation to pelareorep plus a checkpoint inhibitor for second-line treatment of inoperable, locally recurrent, or metastatic squamous cell anal canal cancer, according to Oncolytics Biotech. The decision cites phase 1/2 GOBLET trial results: ORR 30% (6/20), median DOR 15.5 months, 12-month OS 82%.

The FDA granted Fast Track status to pelareorep, an investigational oncolytic reovirus, combined with a checkpoint inhibitor for inoperable, locally recurrent or metastatic squamous cell anal canal cancer after prior systemic therapy. The designation cites the phase 1/2 GOBLET trial with pelareorep plus atezolizumab, reporting ORR 30% (6/20) and median DOR 15.5 months in 2L+ patients. Oncolytics Biotech said it received FDA feedback on a registrational path.

Oncolytics Biotech (Nasdaq: ONCY) said FDA granted Fast Track for pelareorep in RAS-mutant, microsatellite stable metastatic colorectal cancer. The company is enrolling REO 033 Part A (60 patients), with about half the sites activated by end of July and 20+ patients pre-identified. It plans an FDA Type D meeting in August to discuss Part B, a randomized registrational design.

Oncolytics Biotech (NASDAQ:ONCY) shares rose about 5.9% premarket after the company said it will hold a Type D meeting with the FDA in the first half of August to discuss a registrational pathway for its REO 033 trial. It plans to add Part B to support potential accelerated and full approval of pelareorep. Part A enrollment targets 60 patients, with sites activating through July and August.