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Replimune stock soars on FDA priority review for melanoma treatment

Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1,

Business Insider · 1d

Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. 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.

Zacks.com on MSN · 12h

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.

Hosted on MSN · 1d

FDA accepts Replimune's advanced melanoma therapy BLA

Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has been accepted by the U.

1don MSN

Sanofi says FDA lifted clinical hold on trial for Cialis OTC switch

Sanofi’s (NASDAQ:SNY) consumer healthcare unit Opella announced Tuesday that the U.S. FDA has lifted a clinical hold on a ...

Nasdaq12d

FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab

The FDA filing is supported by data from the phase ... We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that ...

Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia

Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...

1don MSN

Atara extends losses after FDA clinical hold

Atara Biotherapeutics (ATRA) stock slips as company faces an FDA clinical hold after rejection of lead candidate Ebvallo.

Hosted on MSN21h

Surging stocks and FDA approval propel Koh Young’s U.S. market ambitions

Koh Young Technology, a South Korean mid-sized company specializing in 3D inspection equipment, has seen its stock price ...

Nasdaq13d

FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV Vaccines Abrysvo And Arexvy

(RTTNews) - The FDA has required the manufacturers of the ... opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...

Nacuity Pharmaceuticals Granted U.S. FDA Fast Track Designation for NPI-001 (N-acetylcysteine amide) Tablets for the Treatment of Retinitis Pigmentosa

A drug that receives Fast Track designation may benefit from more frequent interactions with the FDA throughout drug development. In addition, the Fast Track program allows for Accelerated Approval ...

1don MSN

FDA lifts clinical hold on Amylyx ALS drug study

Shares of Amylyx Pharmaceuticals (NASDAQ:AMLX) fell 13% in morning trading Tuesday amid news that an FDA clinical hold on a Phase 1 study for its ALS drug candidate AMX0114 has been lifted. Amylyx ...

Nasdaq4d

FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...

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