ONCOLYTICS BIOTECH INC 8K

Oncolytics Biotech received FDA Fast Track designation for pelareorep plus a checkpoint inhibitor in second-line and later squamous cell anal cancer, advancing its regulatory path in a high‑unmet‑need gastrointestinal indication.

Oncolytics Biotech Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational immunotherapy pelareorep, in combination with a checkpoint inhibitor, for the treatment of patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal who have progressed on or were intolerant to one or more prior systemic therapies, reinforcing a regulatory pathway toward a pivotal study in a second-line and later setting within an estimated $1 billion U.S. market that currently lacks FDA‑approved options after first-line checkpoint inhibitor plus chemotherapy. The designation, the company’s third Fast Track in gastrointestinal cancers following prior designations in KRAS‑mutated metastatic colorectal cancer and pancreatic cancer, provides enhanced FDA interaction, rolling BLA review, and potential Priority Review eligibility, and is supported by encouraging clinical results from the GOBLET study showing response rates and survival metrics materially better than historical benchmarks, which management believes de‑risks the development program and strengthens the company’s path toward registration.

Filing Facts

CIK

1129928

Ticker

-

Form

8K

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sec

Accession

0001129928-26-000045

Alert Tier

6