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Replimune Stock Plummets 75% After FDA Rejects Application for Skin Cancer Treatment

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1, its lead candidate to treat advanced melanoma in c

Fierce Biotech · 1d

Replimune's shares crater as FDA rejects melanoma drug

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to receive complete response letters from the new-look agency. Investors sent the biotech’s share price down 76% to below $3 in premarket trading.

Seeking Alpha on MSN · 11h

Replimune rebounds despite analyst downgrades on FDA rejection

Despite a sharp drop in the previous session following the FDA rejection of its skin cancer drug RP1, Replimune (NASDAQ:REPL) shares bounced back on Wednesday even as multiple Wall Street analysts downgraded the biotech,

pharmaphorum15h

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 – ...

Replimune (REPL) Shares Plummet After FDA Rejects Melanoma Drug, Sparking Investor Concerns - Hagens Berman

SAN FRANCISCO, July 23, 2025 (GLOBE NEWSWIRE) -- Investors in Replimune Group, a biotechnology company focused on cancer treatments, witnessed a dramatic collapse in their holdings on July 22. Shares ...

Targeted Oncology1d

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 ...

Investor's Business Daily on MSN1d

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 ...

Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application 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 ...

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 ...

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