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Form 8-K ONCOLYTICS BIOTECH INC For: Jul 20

Mon, 20 Jul 2026 09:03:00 -0400

si-local-file:///var/storage/secattach/20260720/26787873.html

Form 8-K ONCOLYTICS BIOTECH INC For: Jul 20

Mon, 20 Jul 2026 09:03:00 -0400

si-local-file:///var/storage/secattach/20260720/26787873.html

FDA grants fast track status to Oncolytics' pelareorep for anal cancer

Mon, 20 Jul 2026 09:01:11 -0400

Oncolytics Biotech Inc. (NASDAQ: ONCY) announced that the U.S. Food and Drug Administration has granted Fast Track designation to 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 lines of systemic therapy.

The designation is the third granted to pelareorep in gastrointestinal cancers, following similar designations for KRAS-mutated metastatic colorectal cancer in February 2026 and pancreatic cancer in late 2022.

Fast Track designation allows for more frequent interactions with the FDA during development, rolling

FDA grants fast track status to Oncolytics' pelareorep for anal cancer

Mon, 20 Jul 2026 09:01:11 -0400

Fast Track designation allows for more frequent interactions with the FDA during development, rolling

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

SAN DIEGO, July 20, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to pelareorep in combination with a checkpoint inhibitor for the treatment

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer

Mon, 20 Jul 2026 09:00:00 -0400

Designation supports development in an estimated $1 billion market where there are no FDA-approved therapies for patients whose disease progresses following first-line standard of care therapy

Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration

H.C. Wainwright Reiterates Buy Rating on Oncolytics Biotech (ONCY)

Tue, 14 Jul 2026 07:00:16 -0400

H.C. Wainwright analyst Pat Trucchio reiterated a Buy rating and $10.00 price target on Oncolytics Biotech (NASDAQ: ONCY).

The analyst commented: "On July 13, Oncolytics provided a clinical and regulatory update on REO 033, its randomized controlled study of pelareorep (pela) plus FOLFIRI (irinotecan and 5- fluorouracil chemotherapy) and bevacizumab (an anti-VEGF monoclonal antibody, mAb) in second-line RAS-mutant, microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). Oncolytics reported rapid operational progress in Part A (n=60), with roughly half of planned clinical sites activated by the end of July, more than 20 patients already pre-identified across participating centers, and the remaining sites expected online

Form 8-K ONCOLYTICS BIOTECH INC For: Jul 13

Mon, 13 Jul 2026 09:04:00 -0400

si-local-file:///var/storage/secattach/20260713/26760696.html

Form 8-K ONCOLYTICS BIOTECH INC For: Jul 13

Mon, 13 Jul 2026 09:04:00 -0400

si-local-file:///var/storage/secattach/20260713/26760696.html

Oncolytics to meet FDA on registrational path for REO 033 trial

Mon, 13 Jul 2026 09:01:13 -0400

Oncolytics Biotech Inc. (NASDAQ: ONCY) announced a clinical and regulatory update on its REO 033 trial, a randomized controlled study evaluating pelareorep in combination with FOLFIRI and bevacizumab for second-line treatment of patients with RAS-mutant, microsatellite stable metastatic colorectal cancer.

The company said approximately half of the planned clinical sites for Part A of REO 033, which targets 60 patients, will be activated by the end of July 2026, with the remaining sites expected to be activated by the end of August. More than 20 patients have been pre-identified across participating centers. Enrollment at Rutgers Cancer Institute of New Jersey was

Oncolytics to meet FDA on registrational path for REO 033 trial

Mon, 13 Jul 2026 09:01:13 -0400

Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial

Mon, 13 Jul 2026 09:00:00 -0400

Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers

Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design