REPL BREAKING NEWS: Replimune Group, Inc. Stock Plummets 75% after FDA Response Letter – BFA Law Announces Securities Fraud Investigation and Urges Investors to Contact the Firm
Leading securities law firm Bleichmar Fonti & Auld LLP announces an investigation into Replimune Group, Inc. (NASDAQ: REPL) for potential violations of the federal securities laws. Share
If you invested in Replimune, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/replimune-group-class-action-lawsuit.
Why is Replimune being Investigated?
Replimune is a clinical-stage biotechnology company focused on developing and commercializing oncolytic immunotherapies for the treatment of cancer. Replimune's lead product candidate is RP1, a treatment for melanoma. On June 6, 2024, the Company announced positive top line results from its IGNYTE Phase 1/2 clinical trial for RP1 in combination with the immunotherapy drug nivolumab. On November 21, 2024, Replimune announced that it had submitted a biologics license application ('BLA') to the FDA for RP1 on the strength of the results of the IGNYTE Phase 1/2 trial.
During the relevant period, the Company repeatedly touted the results of the IGNYTE Phase 1/2 trial. In truth, the IGNYTE Phase 1/2 trial design was not adequate to produce reliable results.
The Stock Declines as the Truth is Revealed
On July 22, 2025, Replimune announced that it received a Complete Response Letter from the FDA regarding the BLA for RP1. According to the Company, '[t]he FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.' More specifically, 'the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population.' On this news, the price of Replimune stock fell more than 75% on July 22, 2025.
Click here for more information: https://www.bfalaw.com/cases-investigations/replimune-group-class-action-lawsuit.
What Can You Do?
If you invested in Replimune you may have legal options and are encouraged to submit your information to the firm.
All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.
Submit your information by visiting:
https://www.bfalaw.com/cases-investigations/replimune-group-class-action-lawsuit
Why Bleichmar Fonti & Auld LLP?
BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It has been named a top plaintiff law firm by Chambers USA, The Legal 500, and ISS SCAS, and its attorneys have been named 'Elite Trial Lawyers' by the National Law Journal, among the top '500 Leading Plaintiff Financial Lawyers' by Lawdragon, 'Titans of the Plaintiffs' Bar' by Law360 and 'SuperLawyers' by Thomson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd.
For more information about BFA and its attorneys, please visit https://www.bfalaw.com.
https://www.bfalaw.com/cases-investigations/replimune-group-class-action-lawsuit
Attorney advertising. Past results do not guarantee future outcomes.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
11 minutes ago
- Yahoo
Axon Soars Past 52-Week High As Outlook Ignites Investor Frenzy
Axon Enterprise Inc. (NASDAQ:AXON) shares surged during Tuesday's regular session after multiple analysts raised their price forecasts following the company's strong second-quarter results and increased full-year revenue guidance. According to Benzinga Pro, Raymond James maintained an Outperform rating on Axon and lifted its price forecast to $855 from $645. UBS reiterated a Neutral rating and raised its forecast to $840 from $820. Needham reaffirmed its Buy rating and boosted its price forecast to $870 from $820. The upgrades came as Axon stock soared past its 52-week high of $830.21. The stock's strong rebound from its 52-week low of $279.02 underscores its recent momentum. Also Read: Axon reported second-quarter earnings of $2.12 per share, beating the consensus estimate of $1.46 by 45.11%. Revenue was $669 million, ahead of the $641.24 million estimate and up from $504.1 million a year earlier. View more earnings on AXON Software and Services revenue rose 39% year-over-year to $292 million. Connected Devices revenue increased 29% to $376 million, while Platform Solutions revenue surged 86% to $67 million. Annual recurring revenue also grew 39% to $1.2 billion. Adjusted gross margin reached 63.3%, improving 20 basis points from the year-ago quarter, excluding stock-based compensation and intangible amortization. Outlook Axon raised its full-year revenue outlook to $2.65 billion to $2.73 billion, up from prior guidance of $2.6 billion to $2.7 billion, compared with the $2.66 billion consensus estimate. AXON is trading 15.75% above its 20-day, 13.04% above its 50-day, and 36.98% above its 200-day simple moving averages, reflecting strong short- and long-term momentum. Price Action: At last check Tuesday, AXON shares were trading higher by 16.4% to $867.17. Read Next:Image via Shutterstock Latest Ratings for AXON Date Firm Action From To Feb 2022 JP Morgan Upgrades Neutral Overweight Feb 2022 Needham Maintains Buy Dec 2021 Morgan Stanley Maintains Overweight View More Analyst Ratings for AXON View the Latest Analyst Ratings UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? AXON ENTERPRISE (AXON): Free Stock Analysis Report This article Axon Soars Past 52-Week High As Outlook Ignites Investor Frenzy originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
11 minutes ago
- Yahoo
What to Watch Ahead of DoorDash Q2 Earnings
DoorDash (NASDAQ:DASH) reports Q2 2025 results after the bell on August 6. Analysts expect $0.44 in EPS on $3.2 billion in revenue, a 20% top-line growth. The stock is up 53% year-to-date and 122% over the past 12 months, recently hitting all-time highs as investors price in margin expansion and platform monetization. The call will spotlight profitability and segment performance. In Q1, DoorDash posted positive adjusted EBITDA and improving contribution margins across U.S. and international markets. Analysts will watch whether new growth areas such as ads, DashPass subscriptions, and logistics infrastructure are contributing meaningfully to cash flow, without pressuring unit economics. Updates on retention, order frequency, and cost control will be central to gauging sustainability. Commentary on the integration of Deliveroo, which DoorDash recently acquired, will also be closely watched. Investors will assess how the acquisition affects DoorDash's international positioning, cost structure, and competitive leverage in key European markets. With sentiment bullish and valuation stretched, Q2 must validate that DoorDash's scale benefits, diversified offerings, and disciplined execution can hold up even if consumer delivery behavior normalizes. This article first appeared on GuruFocus.
Yahoo
11 minutes ago
- Yahoo
Raymond James Reiterates Outperform on Arm Holdings (ARM), Raises PT to $165
Arm Holdings plc (NASDAQ:ARM) is one of the AI Stocks Analysts Are Watching Closely. On July 31, Raymond James analyst Srini Pajjuri raised the price target on the stock to $165.00 (from $140.00) while maintaining an 'Outperform' rating. The rating affirmation follows Arm's fiscal first-quarter results, which were in-line with expectations. However, fiscal second-quarter outlook was weaker than anticipated. Royalty revenue grew 25% year-over-year backed by strong data center performance. This was, despite weakness in smartphone and IoT units. The firm also talked about royalty rate expansion. A financial analyst looking at a monitor filled with stock market charts of U.S. listed semiconductor companies. 'Secular royalty rate expansion remains on track driven by continued ARMv9 adoption. We are also encouraged by early CSS progress (including at Samsung, MSFT, Xiaomi), which essentially doubles the royalty rate. Licensing declined slightly y/y but was better than our model while annualized contract value (ACV) grew 28%.' Looking ahead, the firm is optimistic on the back of strong v9/CSS adoption and growing Data Center opportunity. 'Management also alluded to expanding into chiplets and full end solutions, which could significantly expand SAM, although margin impact remains unclear. We are lowering EPS partly due to higher OpEx but are raising price target from $140 to $165 on recent peer multiple expansion. Reiterate Outperform.' Arm Holdings plc (NASDAQ:ARM) is a semiconductor and software design company that designs and manufactures semiconductor technology and other related products. While we acknowledge the potential of ARM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 Must-Watch AI Stocks on Wall Street and Disclosure: None.
