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) Mon, 01 Jun 2026 05:42:41 -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/Options/Replimune+%28REPL%29+call+put+ratio+1+call+to+1.2+put+amid+sharp+rally/26578100.html <p>Replimune (NASDAQ: REPL) 30-day option implied volatility is at 127; compared to its 52-week range of 77 to 401. Call put ratio 1 call to 1.2 put amid sharp rally.</p> http://www.streetinsider.com/Options/Replimune+%28REPL%29+call+put+ratio+1+call+to+1.2+put+amid+sharp+rally/26578100.html Mon, 01 Jun 2026 05:42:41 -0400 REPL http://www.streetinsider.com/Corporate+News/Replimune+presents+final+data+for+RP2+cancer+treatment+at+oncology+meeting/26577768.html <p>Replimune Group Inc. (NASDAQ: REPL) presented final first-in-human data for its RP2 oncolytic immunotherapy at the American Society of Clinical Oncology annual meeting on May 31, 2026.</p><p>The Phase 1 trial enrolled 85 patients with advanced solid tumors who had received a median of 2 prior systemic therapies. The study evaluated RP2 both as a single treatment and in combination with nivolumab.</p><p>RP2 monotherapy achieved an objective response rate of 19.0% among 21 evaluable patients, with responses in uveal melanoma, esophagogastric adenocarcinoma, chordoma, and mucoepidermoid carcinoma. The combination with nivolumab showed a 19.1% response rate among 47 evaluable patients and a disease http://www.streetinsider.com/Corporate+News/Replimune+presents+final+data+for+RP2+cancer+treatment+at+oncology+meeting/26577768.html Mon, 01 Jun 2026 02:53:47 -0400 REPL http://www.streetinsider.com/FDA/Replimune+presents+final+data+for+RP2+cancer+treatment+at+oncology+meeting/26577768.html <p>Replimune Group Inc. (NASDAQ: REPL) presented final first-in-human data for its RP2 oncolytic immunotherapy at the American Society of Clinical Oncology annual meeting on May 31, 2026.</p><p>The Phase 1 trial enrolled 85 patients with advanced solid tumors who had received a median of 2 prior systemic therapies. The study evaluated RP2 both as a single treatment and in combination with nivolumab.</p><p>RP2 monotherapy achieved an objective response rate of 19.0% among 21 evaluable patients, with responses in uveal melanoma, esophagogastric adenocarcinoma, chordoma, and mucoepidermoid carcinoma. The combination with nivolumab showed a 19.1% response rate among 47 evaluable patients and a disease http://www.streetinsider.com/FDA/Replimune+presents+final+data+for+RP2+cancer+treatment+at+oncology+meeting/26577768.html Mon, 01 Jun 2026 02:53:47 -0400 REPL http://www.streetinsider.com/Upgrades/JPMorgan+Upgrades+Replimune+Group+%28REPL%29+to+Neutral/26577651.html <p>JPMorgan analyst Anupam Rama upgraded Replimune Group (NASDAQ: REPL) from Underweight to Neutral with a price target of $8.00.</p><p>The analyst comments: “Earlier this morning, Replimune noted that following discussions with the FDA, the company and the Agency have agreed on a path for resubmission of RP1+nivolumab in advanced / refractory melanoma.</p><p>Net-net, this is a clear win as potential approval for RP1 in refractory melanoma is back on the table (which is of course balanced against what has been a volatile regulatory process). That said, sentiment on REPL shares will shift more positively on today’s update.</p><p>Indeed, sentiment will also likely improve http://www.streetinsider.com/Upgrades/JPMorgan+Upgrades+Replimune+Group+%28REPL%29+to+Neutral/26577651.html Mon, 01 Jun 2026 01:06:01 -0400 REPL http://www.streetinsider.com/Analyst+Comments/JPMorgan+Upgrades+Replimune+Group+%28REPL%29+to+Neutral/26577651.html <p>JPMorgan analyst Anupam Rama upgraded Replimune Group (NASDAQ: REPL) from Underweight to Neutral with a price target of $8.00.</p><p>The analyst comments: “Earlier this morning, Replimune noted that following discussions with the FDA, the company and the Agency have agreed on a path for resubmission of RP1+nivolumab in advanced / refractory melanoma.</p><p>Net-net, this is a clear win as potential approval for RP1 in refractory melanoma is back on the table (which is of course balanced against what has been a volatile regulatory process). That said, sentiment on REPL shares will shift more positively on today’s update.</p><p>Indeed, sentiment will also likely improve http://www.streetinsider.com/Analyst+Comments/JPMorgan+Upgrades+Replimune+Group+%28REPL%29+to+Neutral/26577651.html Mon, 01 Jun 2026 01:06:01 -0400 REPL http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Press+Releases/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html <p>WOBURN, Mass., May 31, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented final first-in-human data for RP2 alone and in combination with nivolumab in patients with advanced solid tumors during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>Key findings are detailed below.</p> <p><strong>Oral Presentation</strong>: RP2 oncolytic immunotherapy alone and in combination with nivolumab (nivo) in patients with advanced solid tumors: Final safety, efficacy, and biomarker results from the phase 1 first-in-human (FIH) study; <strong>Date/Time</strong>: May 31, http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+Final+First-in-Human+Data+for+RP2+in+Advanced+Solid+Tumors+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577379.html Sun, 31 May 2026 08:00:00 -0400 A.50216726 O.21612337 O.38725784 REPL http://www.streetinsider.com/Press+Releases/Replimune+Presents+3-Year+Landmark+Overall+Survival+Analysis+from+IGNYTE+Clinical+Trial+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577177.html <p>WOBURN, Mass., May 30, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented 3-year landmark overall survival data from the IGNYTE clinical trial of RP1 plus nivolumab in patients with anti-PD-1 failed melanoma during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>“The overall survival analysis from IGNYTE shows that nearly half of all treated patients in the study were alive at three years, including 83.5% of responders to RP1 plus nivolumab,” said Kostas Xynos, MD, PhD, MBA, Chief http://www.streetinsider.com/Press+Releases/Replimune+Presents+3-Year+Landmark+Overall+Survival+Analysis+from+IGNYTE+Clinical+Trial+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577177.html Sat, 30 May 2026 08:00:00 -0400 REPL http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+3-Year+Landmark+Overall+Survival+Analysis+from+IGNYTE+Clinical+Trial+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577177.html <p>WOBURN, Mass., May 30, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented 3-year landmark overall survival data from the IGNYTE clinical trial of RP1 plus nivolumab in patients with anti-PD-1 failed melanoma during an oral session at the 2026 American Society of Clinical Oncology annual meeting.</p> <p>“The overall survival analysis from IGNYTE shows that nearly half of all treated patients in the study were alive at three years, including 83.5% of responders to RP1 plus nivolumab,” said Kostas Xynos, MD, PhD, MBA, Chief http://www.streetinsider.com/Globe+Newswire/Replimune+Presents+3-Year+Landmark+Overall+Survival+Analysis+from+IGNYTE+Clinical+Trial+During+Oral+Presentation+at+the+2026+American+Society+of+Clinical+Oncology+Annual+Meeting/26577177.html Sat, 30 May 2026 08:00:00 -0400 REPL http://www.streetinsider.com/Upgrades/JPMorgan+Upgrades+Replimune+Group+%28REPL%29+to+Neutral/26572859.html <p>JPMorgan analyst Anupam Rama upgraded Replimune Group (NASDAQ: REPL) from Underweight to Neutral with a price target of $8.00.</p><p>For an analyst ratings summary and ratings history on Replimune Group <a href="http://www.streetinsider.com/rating_history.php?q=REPL">click here</a>. For more ratings news on Replimune Group <a href="http://www.streetinsider.com/stock_lookup_news.php?q=REPL&amp;type=analyst">click here</a>.</p><p>Shares of Replimune Group closed at $4.68 yesterday.</p> http://www.streetinsider.com/Upgrades/JPMorgan+Upgrades+Replimune+Group+%28REPL%29+to+Neutral/26572859.html Fri, 29 May 2026 13:15:55 -0400 REPL http://www.streetinsider.com/Options/Replimune+%28REPL%29+call+put+ratio+1.4+calls+to+1+put+as+share+price+up+83%25/26572429.html <p>Replimune (NASDAQ: REPL) 30-day option implied volatility is at 133; compared to its 52-week range of 77 to 401. Call put ratio 1.4 calls to 1 put as share price up 83%.</p> http://www.streetinsider.com/Options/Replimune+%28REPL%29+call+put+ratio+1.4+calls+to+1+put+as+share+price+up+83%25/26572429.html Fri, 29 May 2026 10:49:27 -0400 REPL http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Replimune+Group%2C+Inc.+++++For%3A+May+29/26571753.html si-local-file:///var/storage/secattach/20260529/26571753.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Replimune+Group%2C+Inc.+++++For%3A+May+29/26571753.html Fri, 29 May 2026 09:56:00 -0400 O.38725784 REPL http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Replimune+Group%2C+Inc.+++++For%3A+May+29/26571753.html si-local-file:///var/storage/secattach/20260529/26571753.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++Replimune+Group%2C+Inc.+++++For%3A+May+29/26571753.html Fri, 29 May 2026 09:56:00 -0400 O.38725784 REPL http://www.streetinsider.com/Corporate+News/Replimune+plans+RP1+cancer+drug+resubmission+after+FDA+talks/26570914.html <p>Replimune Group Inc. (NASDAQ: REPL) announced it will resubmit its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment following discussions with the U.S. Food and Drug Administration.</p><p>The Woburn, Massachusetts-based biotechnology company said the FDA indicated it would treat the BLA resubmission as urgent and prioritize its review. The resubmission will occur in the coming days, according to a company statement.</p><p>RP1, also known as vusolimogene oderparepvec, is an oncolytic immunotherapy based on a genetically engineered herpes simplex virus. The treatment is designed for patients with advanced melanoma who have progressed on prior anti-PD-1 based therapy.</p><p>"We are http://www.streetinsider.com/Corporate+News/Replimune+plans+RP1+cancer+drug+resubmission+after+FDA+talks/26570914.html Fri, 29 May 2026 08:01:50 -0400 REPL http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html <p>WOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.</p> <p>The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html Fri, 29 May 2026 08:00:00 -0400 A.06822034 O.20026344 O.38725784 REPL http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html <p>WOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.</p> <p>The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html Fri, 29 May 2026 08:00:00 -0400 A.06822034 O.20026344 O.38725784 REPL http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html <p>WOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.</p> <p>The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html Fri, 29 May 2026 08:00:00 -0400 A.06822034 O.20026344 O.38725784 REPL http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html <p>WOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.</p> <p>The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent http://www.streetinsider.com/Press+Releases/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html Fri, 29 May 2026 08:00:00 -0400 A.06822034 O.20026344 O.38725784 REPL http://www.streetinsider.com/Globe+Newswire/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html <p>WOBURN, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.</p> <p>The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent http://www.streetinsider.com/Globe+Newswire/Replimune+Announces+Planned+RP1+BLA+Resubmission+Following+Productive+Discussion+with+FDA/26570886.html Fri, 29 May 2026 08:00:00 -0400 A.06822034 O.20026344 O.38725784 REPL