http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Wed, 19 Aug 2026 06:45:04 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/Analyst+PT+Change/Oncolytics+Biotech+%28ONCY%29+PT+Lowered+to+%245+at+H.C.+Wainwright/26946956.html (Updated - August 19, 2026 6:45 AM EDT) <p>H.C. Wainwright analyst Pat Trucchio lowered the price target on Oncolytics Biotech (NASDAQ: ONCY) to $5.00 (from $10.00) while maintaining a Buy rating.</p><p>The analyst commented: "A registration-directed Part B for REO 033 and sharpened pipeline support advancement of pela toward pivotal development, in our view. On August 18, Oncolytics announced it received written FDA feedback that it believes represents important alignment on a potential pivotal Part B expansion of the ongoing randomized Phase 2 REO 033 trial evaluating pelareorep (pela), an intravenously (IV) delivered, non-genetically modified reovirus-based immunotherapy, in second-line (2L) RAS-mutated, microsatellite http://www.streetinsider.com/Analyst+PT+Change/Oncolytics+Biotech+%28ONCY%29+PT+Lowered+to+%245+at+H.C.+Wainwright/26946956.html Wed, 19 Aug 2026 06:45:04 -0400 ONCY http://www.streetinsider.com/Analyst+Comments/Oncolytics+Biotech+%28ONCY%29+PT+Lowered+to+%245+at+H.C.+Wainwright/26946956.html (Updated - August 19, 2026 6:45 AM EDT) <p>H.C. Wainwright analyst Pat Trucchio lowered the price target on Oncolytics Biotech (NASDAQ: ONCY) to $5.00 (from $10.00) while maintaining a Buy rating.</p><p>The analyst commented: "A registration-directed Part B for REO 033 and sharpened pipeline support advancement of pela toward pivotal development, in our view. On August 18, Oncolytics announced it received written FDA feedback that it believes represents important alignment on a potential pivotal Part B expansion of the ongoing randomized Phase 2 REO 033 trial evaluating pelareorep (pela), an intravenously (IV) delivered, non-genetically modified reovirus-based immunotherapy, in second-line (2L) RAS-mutated, microsatellite http://www.streetinsider.com/Analyst+Comments/Oncolytics+Biotech+%28ONCY%29+PT+Lowered+to+%245+at+H.C.+Wainwright/26946956.html Wed, 19 Aug 2026 06:45:04 -0400 ONCY http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Aug+18/26941704.html si-local-file:///var/storage/secattach/20260818/26941704.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Aug+18/26941704.html Tue, 18 Aug 2026 09:03:00 -0400 O.02608059 ONCY http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Aug+18/26941704.html si-local-file:///var/storage/secattach/20260818/26941704.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Aug+18/26941704.html Tue, 18 Aug 2026 09:03:00 -0400 O.02608059 ONCY http://www.streetinsider.com/Corporate+News/Oncolytics+gets+FDA+feedback+on+colorectal+cancer+trial+expansion/26941664.html <p>Oncolytics Biotech Inc. (Nasdaq: ONCY) announced it has received written feedback from the U.S. Food and Drug Administration regarding the design of a potential pivotal expansion of its REO 033 clinical study, which is evaluating pelareorep in second-line RAS-mutant, microsatellite stable metastatic colorectal cancer.</p><p>The company had submitted a Type D meeting request to the FDA seeking feedback on whether the ongoing randomized Part A of REO 033 could support expansion into a pivotal Part B, and whether that expansion could support a potential accelerated approval pathway based on objective response rate and duration of response, with progression-free survival as the http://www.streetinsider.com/Corporate+News/Oncolytics+gets+FDA+feedback+on+colorectal+cancer+trial+expansion/26941664.html Tue, 18 Aug 2026 09:01:50 -0400 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html <p align="center"><em>FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study</em></p> <p align="center"><em>Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full</em> <em>approval</em></p> <p align="center"><em>Pivotal expansion to follow initial clinical data from the ongoing randomized Part A</em></p> <p align="justify">SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the design http://www.streetinsider.com/Globe+Newswire/Oncolytics+Biotech%C2%AE+Aligns+with+FDA+on+Registrational+Path+for+Second-Line+RAS-Mutant+MSS+Colorectal+Cancer/26941520.html Tue, 18 Aug 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jun+30/26913204.html si-local-file:///var/storage/secattach/20260812/26913204.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jun+30/26913204.html Wed, 12 Aug 2026 16:19:00 -0400 O.02608059 ONCY http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jun+30/26913204.html si-local-file:///var/storage/secattach/20260812/26913204.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jun+30/26913204.html Wed, 12 Aug 2026 16:19:00 -0400 O.02608059 ONCY http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26814003.html si-local-file:///var/storage/secattach/20260724/26814003.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26814003.html Fri, 24 Jul 2026 16:40:00 -0400 O.02608059 ONCY http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26814003.html si-local-file:///var/storage/secattach/20260724/26814003.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26814003.html Fri, 24 Jul 2026 16:40:00 -0400 O.02608059 ONCY http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26787873.html si-local-file:///var/storage/secattach/20260720/26787873.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26787873.html Mon, 20 Jul 2026 09:03:00 -0400 O.02608059 ONCY http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26787873.html si-local-file:///var/storage/secattach/20260720/26787873.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++ONCOLYTICS+BIOTECH+INC++++For%3A+Jul+20/26787873.html Mon, 20 Jul 2026 09:03:00 -0400 O.02608059 ONCY http://www.streetinsider.com/Corporate+News/FDA+grants+fast+track+status+to+Oncolytics%27+pelareorep+for+anal+cancer/26787847.html <p>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.</p><p>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.</p><p>Fast Track designation allows for more frequent interactions with the FDA during development, rolling http://www.streetinsider.com/Corporate+News/FDA+grants+fast+track+status+to+Oncolytics%27+pelareorep+for+anal+cancer/26787847.html Mon, 20 Jul 2026 09:01:11 -0400 ONCY http://www.streetinsider.com/FDA/FDA+grants+fast+track+status+to+Oncolytics%27+pelareorep+for+anal+cancer/26787847.html <p>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.</p><p>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.</p><p>Fast Track designation allows for more frequent interactions with the FDA during development, rolling http://www.streetinsider.com/FDA/FDA+grants+fast+track+status+to+Oncolytics%27+pelareorep+for+anal+cancer/26787847.html Mon, 20 Jul 2026 09:01:11 -0400 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html <p align="center"><em>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</em></p> <p align="center"><em>Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration</em></p> <p align="justify">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 http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html Mon, 20 Jul 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html <p align="center"><em>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</em></p> <p align="center"><em>Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration</em></p> <p align="justify">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 http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html Mon, 20 Jul 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html <p align="center"><em>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</em></p> <p align="center"><em>Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration</em></p> <p align="justify">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 http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html Mon, 20 Jul 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html <p align="center"><em>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</em></p> <p align="center"><em>Third Fast Track designation in gastrointestinal cancers strengthens Oncolytics’ regulatory momentum and continues to advance the Company’s path toward registration</em></p> <p align="justify">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 http://www.streetinsider.com/Press+Releases/Oncolytics+Biotech%C2%AE+Receives+Fast+Track+Designation+for+Pelareorep+in+Second-Line+and+Later+Anal+Cancer/26787776.html Mon, 20 Jul 2026 09:00:00 -0400 A.06822034 O.02608059 O.20026344 ONCY