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Two Rejections, Messy Process: Replimune Finally Secures FDA Approval for Skin Cancer Treatment

The FDA has granted accelerated approval to Replimune Group Inc. for its novel oncolytic immunotherapy, Tudriqev, for advanced cutaneous melanoma. This approval comes after previous rejections and relies on promising clinical trial results from the IGNYTE trial, which showed a 24.2% objective response rate …

Is Repligen’s (RGEN) Rising Revenue But Softer Earnings Rewriting Its Profitability Story?

Repligen Corporation (RGEN) reported rising revenue in Q2 2026, reaching US$204.13 million, but net income and earnings per share fell compared to the previous year. This performance highlights a conflict between increased demand and pressure on profitability due to the company's cost structure and …

Law Offices of Frank R. Cruz Encourages Replimune Group, Inc. (REPL) Shareholders To Inquire About Securities Fraud Class Action

The Law Offices of Frank R. Cruz has filed a class action lawsuit against Replimune Group, Inc. (REPL) on behalf of shareholders who purchased securities between October 20, 2025, and April 10, 2026. The lawsuit alleges that Replimune made materially false and misleading statements …

Replimune Group Inc (REPL) Earnings Forecast: Future EPS & Revenue Growth Estimates

Replimune Wins FDA Skin Cancer Drug Approval on Third Try. Why the Stock Is Tumbling.

Replimune secures FDA approval for Tudriqev on its third attempt, making it the company’s first product on the market. Continue Reading

Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against Replimune Group, Inc. (REPL)

NEW YORK, Aug. 07, 2026 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the District of Massachusetts on behalf of all persons or entities who purchased or otherwise …

REPL INVESTOR ALERT: Class Action Lawsuit Filed on Behalf of Replimune Group Investors – Holzer & Holzer, LLC Encourages Investors With Significant Losses to Contact the Firm

ATLANTA, Aug. 07, 2026 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Replimune Group, Inc. (“Replimune”) (NASDAQ: REPL). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information, including allegations that: (1) …

Replimune Group Inc (REPL) Stock News Today

Replimune Wins FDA Accelerated Nod For TUDRIQEVTM In Advanced Melanoma

(RTTNews) - Replimune Group, Inc. (REPL) announced that the U.S. FDA has granted accelerated approval for TUDRIQEVTM, in combination with Nivolumab (Bristol Myers Squibb), for adults with unresectable advanced cutaneous melanoma who have progressed following anti-PD-1 antibody-based therapy. Advanced melanoma patients often face limited …

Stockholder Alert: Robbins LLP Informs Investors of the Replimune Group, Inc. Class Action

Robbins LLP has filed a class action lawsuit against Replimune Group, Inc. on behalf of investors who purchased securities between October 20, 2025, and April 10, 2026. The lawsuit alleges that Replimune misled investors regarding the efficacy of its lead product candidate, RP1, particularly …

Replimune Group, Inc. (REPL) Stock Price, News, Quote & History

This article provides comprehensive information on Replimune Group, Inc. (REPL), a clinical-stage biotechnology company focused on cancer immunotherapies. It includes current stock price, historical performance data, financial overview, analyst insights, and comparisons with similar companies. The stock showed an 8.71% increase at close on …

Replimune gains accelerated approval of Tudriqev for cutaneous melanoma

[Dermoscopic image of malignant melanoma skin tumor] Izzet Esmece/iStock via Getty Images * The US FDA has granted accelerated approval to Replimune's (REPL [https://seekingalpha.com/symbol/REPL]) gene therapy Tudriqev (vusolimogene oderparepvec) in combination with Bristol Myers Squibb's (BMY [https://seekingalpha.com/symbol/BMY]) Opdivo (nivolumab) as a second-line treatment for …

Replimune Group (REPL): Montanova-affiliated investors report over 7% ownership

Montanova Capital, LLC and affiliated investors, including Aaron Cowen, have reported a significant ownership stake in Replimune Group, Inc. (REPL) via a Schedule 13G/A filing. Montanova Capital and Aaron Cowen each beneficially own 7.9% of Replimune's common stock, while Averill Master Fund, Ltd. holds …

FDA Approves Replimune’s Melanoma Drug on Third Attempt

The FDA has approved Replimune Group's melanoma drug, Tudriqev, after two prior rejections due to clinical data quality concerns. Tudriqev is a genetically modified virus injected into tumors to kill cancer cells and activate an immune response. This approval marks the end of a …

US FDA approves Replimune's skin cancer drug after prior rejections

The U.S. FDA has approved Replimune's drug Tudriqev, in combination with Bristol Myers Squibb's Opdivo, for a difficult-to-treat form of advanced melanoma. This approval marks Replimune's first marketed product after previous rejections, and the drug will compete with Iovance Biotherapeutics' Amtagvi. The decision was …

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

Replimune announced that the FDA has granted accelerated approval for TUDRIQEVTM (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who have progressed on anti-PD-1 therapy. This approval is based on objective response rate and duration of response from the …

Melanoma therapy after anti-PD-1 progression gets FDA accelerated approval

Replimune announced that the FDA has granted accelerated approval for TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed on anti-PD-1 therapy. This approval is based on results from the Phase 1/2 IGNYTE trial, showing a 24.2% objective …

BioLife Solutions (NASDAQ: BLFS) plans cash-stock merger with Repligen

Bragar Eagel & Squire, P.C. is Investigating Replimune Group Inc. on Behalf of Replimune Stockholders and Encourages Investors to Contact the Firm

If you purchased or acquired stock in Replimune and would like to discuss your legal rights, contact Bragar Eagel & Squire partners Brandon Walker or Melissa Fortunato by email at investigations@bespc.com or by telephone at (212) 355-4648. Click here to participate in the action. …

California State Teachers Retirement System Raises Holdings in Repligen Corporation $RGEN

The California State Teachers Retirement System increased its stake in Repligen Corporation (NASDAQ:RGEN) by 22.1% in the first quarter, now holding 61,860 shares valued at $7.3 million. Repligen exceeded analyst expectations with quarterly revenue of $204.13 million and earnings of $0.54 per share, and …

Moody National Bank Trust Division Makes New Investment in Repligen Corporation $RGEN

Moody National Bank Trust Division has acquired a new stake in Repligen Corporation (NASDAQ:RGEN), purchasing 17,728 shares valued at approximately $2.42 million. This investment comes as institutional investors collectively own 97.64% of the biotechnology company. Repligen recently reported strong quarterly earnings, exceeding analyst expectations …

Biotech Stocks At 52-Week Highs - UFPT +25%, INFU +33%, SOPH +20% On Q2 Reports, REPL, PBLS

(RTTNews) - The following biotech stocks reached a 52-week high on August 4, 2026, driven by key catalysts like positive quarterly results or certain regulatory milestones. UFP Technologies Inc. (UFPT) UFP Technologies is a contract development and manufacturing organization specializing in solutions for medical …

REPL SHAREHOLDER ALERT: Replimune Group Inc. Investors Encouraged to Contact Kirby McInerney LLP About Potential Securities Laws Violations

Kirby McInerney LLP is investigating Replimune Group Inc. (NASDAQ: REPL) following a significant drop in its stock price. The decline occurred after the FDA deemed Replimune's mid-stage study for its skin cancer drug "non interpretable," raising concerns about potential federal securities law violations. Investors …

Replimune Group : REPL

This article provides an overview of Replimune Group Inc. (REPL), a biotechnology firm specializing in oncolytic immunotherapies for cancer treatment. It

Leerink Partners Upgrades Replimune Group to Outperform From Market Perform, Adjusts Price Target to $17 From $11

Leerink Partners has upgraded Replimune Group to "Outperform" from "Market Perform" and raised its price target to $17 from $11. This upgrade follows a series of positive developments for Replimune, including favorable outcomes from an FDA Advisory Committee meeting for its lead product candidate, …

Class Action Alert: Levi & Korsinsky Reminds Replimune Group, Inc. (REPL) Investors of September 22, 2025 Deadline

Levi & Korsinsky reminds investors of Replimune Group, Inc. (REPL) about a class action lawsuit with a September 22, 2025 deadline. The lawsuit alleges that Replimune Group, Inc. made false and misleading statements about the IGNYTE trial, which the FDA deemed inadequate. Investors who …

Repligen Corporation (BLFS) sets cash and stock terms for BioLife Solutions buyout

Repligen Corporation has announced an agreement to acquire BioLife Solutions for a combination of cash and stock. BioLife shareholders will receive $11.25 in cash plus 0.1442 shares of Repligen common stock for each BioLife share. The transaction, described as a strategic combination in the …

BioLife Solutions (NASDAQ: BLFS) shares Repligen merger video with staff

BioLife Solutions (NASDAQ: BLFS) has informed its employees about its pending merger with Repligen Corporation, distributing an internal email with a video from Repligen's CEO. The video introduces Repligen and discusses the anticipated benefits of the combination, particularly growth opportunities in the cell therapy …

How Repligen Corporation (RGEN) Affects Rotational Strategy Timing

This article analyzes Repligen Corporation (RGEN) using AI models to offer trading strategies. It highlights a strong near-term sentiment with a neutral mid- and long-term outlook, identifying an exceptional risk-reward setup. The analysis provides specific entry, target, and stop-loss levels for position, momentum, and …

Repligen Number of Employees 2026 | Employee Count & Headcount Data

Repligen Corp. (NASDAQ: RGEN) had approximately 1,994 employees worldwide as of March 2026, representing a 1.7% growth from 2023. The company is actively hiring, though job postings declined by 16.1% in 2026. The majority of its workforce is located in the United States, and …

Repligen: Acquisition To Add Cell Therapy Capabilities (NASDAQ:RGEN)

Why Repligen (RGEN) Is Up 6.9% After Mixed Q2 2026 Results With Higher Revenue And Lower EPS

Repligen (RGEN) stock increased by 6.9% despite mixed Q2 2026 results which showed higher revenue but lower EPS. The company reported revenue of US$204.13 million, up from US$182.37 million year-over-year, but net income and diluted EPS declined. Analysts have revised earnings estimates higher, maintaining …

Why Replimune Group (REPL) Is Up 15.5% After Key FDA Panel Backing For RP1 Data - And What's Next

Replimune Group's stock (REPL) rose 15.5% after an FDA advisory committee voted 10–3 that the efficacy data from its IGNYTE trial for RP1 in advanced melanoma are evaluable and clinically meaningful, ahead of an August 2, 2026 action date. The article highlights the importance …

Repligen Corp (RGEN) Institutional Confidence

Repligen Corp (RGEN) has an institutional confidence score of 10.00, placing it first in its industry. Institutional shareholding increased by 3.23% quarter-over-quarter, with Lee Ainslie being the largest shareholder. The article lists the top institutional shareholders and their recent activity.

Replimune Group, Inc. Actuals & Estimates (NASDAQ:REPL)

This article provides an overview of Replimune Group, Inc. (NASDAQ:REPL) financial actuals, estimates, and stock performance. It covers current stock price, historical highs and lows, market capitalization, earnings reports, and analyst forecasts. The article also addresses frequently asked questions about investing in REPL stock …

This Biotech Stock Soars 107% After Key FDA Panel Vote on Skin Cancer Treatment

Replimune Group's stock surged by 107% after an FDA panel voted 10-3 in favor of its experimental skin cancer treatment. This positive vote indicates a significant step forward for the biotechnology company's new therapy.