News

pharmaphorum3h

Replimune receives CRL on BLA for RP1 for advanced melanoma

Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...
Investor's Business Daily on MSN18h

Why Replimune's Surprise Rejection Rattled Wall Street, And Cratered Its Stock

Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...
Targeted Oncology22h

FDA Issues CRL for RP1 in Advanced Melanoma

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

Replimune: A Surprise CRL Exposes Fragility Of The Melanoma Program

Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...
PharmExec21h

FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (CT03767348) trial in advanced melanoma was not ...
Healio20h

FDA rejects RP1 for advanced melanoma, says IGNYTE not a ‘well-controlled’ trial

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...
Explore more

Iovance: I'm Switching From Sell To Buy Despite Likely Approval For Rival Drug

Iovance Biotherapeutics, Inc. stock faces challenges with disappointing Q1 earnings and competition. Click for why potential ...