FDA, Priority Review and REPL

REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA
Replimune Group, Inc. REPL announced that the FDA has accepted the biologics license application (BLA) for its lead pipeline candidate, RP1 (vusolimogene oderparepvec), in combination with Bristol Myers’ BMY Opdivo (nivolumab) to treat adult patients with advanced melanoma.
Strong Buy Rating for Replimune Group Due to Promising RP1 + Opdivo Results and Favorable FDA Review
In a report released today, Robert Burns from H.C. Wainwright reiterated a Buy rating on Replimune Group (REPL – Research Report), with a price
FDA accepts Replimune’s melanoma candidate for priority review
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma.
FDA Accepts BLA for RP1 With Nivolumab in Advanced Melanoma
The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the FDA with priority review.
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. For more information, please visit https://replimune.com/clinical-trials/ignyte-3/.
Replimune Stock Soars 16% on FDA Priority Review for Advanced Melanoma Therapy
Replimune Group ( REPL, Financials) shares surged 17% to $11.85 as of 10:18 a.m. ET Tuesday after the U.S. Food and Drug Administration granted Priority Review for its Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma.
Replimune's SWOT analysis: oncolytic immunotherapy stock faces pivotal year
Replimune Group Inc (NASDAQ:REPL), a biotechnology company specializing in oncolytic immunotherapy for cancer treatment, ...
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BLA Accepted for Melanoma Combination Therapy, RP1 and Nivolumab
The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22 ...
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Replimune's SWOT analysis: biotech firm's stock poised for growth in oncology
Recent developments have placed Replimune on a promising trajectory. The company is preparing for a crucial milestone: the submission of a Biologics License Application (BLA) for RP1 in advanced ...
Charles Schwab Posts Upbeat Earnings, Joins Redwire, Evolus, Replimune Group And Other Big Stocks Moving Higher On Tuesday
Evolus Inc EOLS shares jumped 35.6% to $14.25 after the company announced it expects FDA approval for Evolysse gels within 90 ...
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Replimune Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
WOBURN, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies ...
Replimune stock price target raised to $27 by BMO Capital
Replimune Group Inc . (NASDAQ:REPL), currently trading at $11.70, saw its price target increased to $27.00 from $18.00 by BMO Capital, with the firm maintaining an Outperform rating on the stock.