Biotechnology

Replimune

FDA rejection of Replimune's cancer drug leads to stock price drop

Replimune released FY2026 Q3 earnings on February 3, 2026 (EST), with actual revenue of USD 0 (forecast USD 0) and actual EPS of USD -0.7699 (forecast USD -0.8069)

Replimune released FY2026 9 Months Earnings on February 3, 2026 (EST) with actual revenue of USD 0 and EPS of USD -2.6207

Replimune Group's IGNYTE Clinical Trial Shows PD-1 Resistance Reversal

Replimune Publishes Clinical Research Document on Non-Small Cell Skin Cancer and MSI-H/dMMR Solid Tumors

Replimune released FY2026 Semi-Annual earnings on November 6, 2025 (EST), with actual revenue of USD 0 and EPS of USD -1.8512

Replimune released FY2026 Q2 earnings on November 6 (EST), actual revenue USD 0 (forecast USD 500K), actual EPS USD -0.904 (forecast USD -0.787)

HC Wainwright Maintains Replimune Group 'Buy' Rating, Projects Earnings Per Share of $0.53

Replimune Group's RP1 Application Accepted by FDA

Leerink Partners Raises Replimune's Rating to Outperform

FDA Accepts Replimune Group's RP1 Biologics License Application Resubmission

Replimune reports 44% objective response rate for RP1 and nivolumab combination in treating acral melanoma

Replimune Group Releases Data on Combined Therapy Clinical Trial

Replimune Group Inc. Communicates With FDA On RP1 For Late-Stage Melanoma

Replimune Group Inc. Schedules A-Category Meeting with FDA to Discuss RP1 Treatment

Replimune Group Inc. Discusses RP1 Biologics License Application with FDA

Replimune Group Inc. CFO Reports Common Stock Disposition

Replimune released FY2026 Q1 earnings on August 7 (EST), actual revenue USD 0 (forecast USD 0), actual EPS USD -0.9499 (forecast USD -0.8)

Cantor Fitzgerald Upgrades Replimune Rating

FDA Issues CRL to Replimune, Causing Stock to Plunge

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In Wednesday's intraday session, Quantum Cyber (NASDAQ:QUCY) saw a significant gain of 163.0%, reaching $0.85, while Whitehawk Therapeutics (NASDAQ:WHWK) rose 29.59% to $5.08. Other notable gainers included Replimune Group (NASDAQ:REPL) up 29.09% to $5.28, and MaxCyte (NASDAQ:MXCT) up 27.09% to $1.04. Conversely, WORK Medical Tech Gr (NASDAQ:WOK) experienced a sharp decline of 70.3% to $1.98, with Reviva Pharma (NASDAQ:RVPH) down 44.59% to $0.44. TriSalus Life Sciences (NASDAQ:TLSI) fell 40.36% to $2.72, and OptimizeRx (NASDAQ:OPRX) decreased by 25.56% to $4.72. Q1 earnings reports influenced these movements.

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12 Health Care Stocks Moving In Wednesday's Intraday Session

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Bicara Therapeutics has appointed Chris Sarchi as its chief commercial officer as it prepares for a potential accelerated approval of its cancer drug next year. Sarchi, previously at Replimune and Sanofi, joins at a crucial time following significant layoffs after an FDA rejection of a melanoma drug. Bicara aims to leverage a $362 million IPO to support trials for its lead asset, ficerafusp alfa, currently in a pivotal trial for head and neck cancer. Sarchi's role will be pivotal in transitioning Bicara into a commercial biotech.

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Bicara Therapeutics hires Replimune, Sanofi alum as CCO

LABD

Replimune Inc. (NASDAQ:REPL) is facing significant stock decline, down 15.18% to $2.58, amid criticism of FDA leadership by Commissioner Marty Makary. The FDA's rejection of Replimune's melanoma treatment has raised concerns over inconsistent review processes and limited patient access to potentially life-saving therapies. Makary defended the FDA's decisions, stating that multiple independent review teams supported the rejections. Replimune's stock has dropped approximately 63.5% over the past month, contrasting with a 10.3% rise in the S&P 500.

Replimune(REPL.US)

12 Health Care Stocks Moving In Wednesday's Intraday Session

Bicara Therapeutics hires Replimune, Sanofi alum as CCO

What's Going On With Replimune Stock On Tuesday?