Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer
Oncolytics Biotech Inc. - Common Shares (ONCY)
Last oncolytics biotech inc. - common shares earnings: 11/12 04:00 pm
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Company Research
Source: GlobeNewswire
Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026 Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin®) and leucovorin, fluorouracil, irinotecan (“FOLFIRI”) for the treatment of patients with KRAS (“Kirsten rat sarcoma”)-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”) in the second-line (“2L”) setting. A
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News
- $207B Market Shift: The Race for Fast Track Approval in Oncology [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- The $71 Billion Cancer Shift: Why The FDA Is Speeding UpGlobeNewswire
- $170B Patent Cliff Ignites Biotech Deal Wave: Late-Stage Platforms Command Premium [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- $668B Oncology Surge: 5 Platforms Cracking the Code on GI Tumors [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- $668B Oncology Surge: 5 Platforms Cracking the Code on GI TumorsPR Newswire
ONCY
Earnings
- 11/12/25 - Miss
ONCY
Sec Filings
- 2/4/26 - Form 8-K
- 1/20/26 - Form 4
- 1/15/26 - Form 8-K
- ONCY's page on the SEC website