Efficacy Highlights - The study demonstrated a high Objective Response Rate (ORR) of 65.2% in ICI-naive advanced melanoma patients treated with lifileucel + pembrolizumab [25], with a Complete Response (CR) rate of 30.4% [25] - All response-evaluable patients (N=22) showed regression of target lesions [5, 25] - The median Duration of Response (mDOR) was not reached, indicating durable responses, with a median follow-up of 21.7 months [36, 39] - 73.3% of responders had a Duration of Response (DOR) of at least 6 months, and 53.3% had a DOR of at least 12 months [36] Safety Profile - The safety profile of lifileucel combined with pembrolizumab is considered manageable and differentiated from ICI combination regimens [5, 51] - Common non-hematologic Treatment-Emergent Adverse Events (TEAEs) included chills (82.6%), pyrexia (78.3%), and nausea (78.3%) [18] - Grade 3/4 hematologic lab abnormalities, such as neutropenia, lymphopenia, leukopenia, and thrombocytopenia, resolved to Grade ≤2 by Day 30 in a high percentage of patients (ranging from 78.3% to 100%) [22] Trial Design and Future Directions - IOV-COM-202 is a Phase 2, multicohort, multicenter study evaluating lifileucel + pembrolizumab in patients with solid tumors, including ICI-naive melanoma [9, 10] - These results support the ongoing TILVANCE-301, a registrational, randomized Phase 3 trial assessing lifileucel + pembrolizumab in frontline advanced melanoma [5, 43]

Core Viewpoint - Iovance Biotherapeutics, Inc. is facing a class action securities lawsuit due to alleged securities fraud that negatively impacted investors between May 9, 2024, and May 8, 2025 [1][2]. Group 1: Allegations and Financial Impact - The lawsuit claims that Iovance provided misleadingly positive statements while concealing material adverse facts about its growth potential and ability to meet demand for its treatments [2]. - On July 25, 2024, Iovance announced a reduction in its revenue guidance for fiscal year 2024, attributing this to maintenance issues, lower-than-expected Proleukin sales, and a variable pace of treatment initiation at approved centers [2]. - Following the announcement, Iovance's stock price plummeted from $3.17 per share on May 8, 2025, to $1.75 per share on May 9, 2025, marking a decline of approximately 44.8% in one day [2]. Group 2: Legal Proceedings and Participation - Investors who suffered losses during the specified period have until July 14, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without incurring any out-of-pocket costs or fees [3]. Group 3: Legal Firm Background - Levi & Korsinsky, LLP has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the United States [4].

Core Viewpoint - Iovance Biotherapeutics, Inc. is facing a class action lawsuit due to allegations of providing misleading statements about its growth potential and financial performance, leading to a significant drop in stock price [1][2]. Summary by Relevant Sections Allegations - The complaint claims that during the class period from May 9, 2024, to May 8, 2025, Iovance made overwhelmingly positive statements while concealing material adverse facts about its ability to generate demand for its treatments [1]. - The company announced reduced revenue guidance for fiscal year 2024, attributing this to maintenance issues, lower-than-expected Proleukin sales, and a variable pace in treatment initiation [1]. Financial Impact - Following the announcement of reduced guidance, Iovance's stock price plummeted from $3.17 per share on May 8, 2025, to $1.75 per share on May 9, 2025, marking a decline of approximately 44.795% in one day [1]. Next Steps for Shareholders - Shareholders who purchased Iovance shares during the specified class period are encouraged to register for the class action by July 14, 2025, to potentially become lead plaintiffs [2]. - Registered shareholders will receive updates through a portfolio monitoring software regarding the case's progress [2]. Law Firm's Commitment - The Gross Law Firm aims to protect investors' rights and seeks recovery for losses incurred due to misleading statements that artificially inflated Iovance's stock price [3].

Core Viewpoint - Iovance Biotherapeutics, Inc. is facing a class action lawsuit due to allegations of providing misleading statements about its growth potential while failing to meet revenue expectations, leading to a significant drop in stock price [1][3]. Summary by Relevant Sections Class Period and Allegations - The class period for the lawsuit is from May 9, 2024, to May 8, 2025 [3]. - Allegations include that Iovance made overwhelmingly positive statements while concealing material adverse facts about its ability to generate demand for its treatments [3]. Financial Performance and Stock Impact - On July 25, 2024, Iovance announced disappointing financial results for Q2 2024 and reduced its revenue guidance for the full fiscal year 2024 [3]. - Contributing factors to the lowered guidance included maintenance of the iCTC, lower than expected Proleukin sales, and a variable pace of treatment initiation at approved centers [3]. - Following the announcement, Iovance's stock price plummeted from $3.17 per share on May 8, 2025, to $1.75 per share on May 9, 2025, marking a decline of approximately 44.8% in one day [3]. Next Steps for Shareholders - Shareholders are encouraged to register for the class action by July 14, 2025, to potentially become lead plaintiffs [4]. - Registered shareholders will receive updates through a portfolio monitoring software regarding the case [4]. Law Firm Information - The Gross Law Firm is representing the shareholders and is recognized for its commitment to protecting investor rights against deceit and fraud [5].

Core Viewpoint - A lawsuit has been filed against Iovance Biotherapeutics, Inc. and certain senior executives for potential violations of federal securities laws, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 [1][2]. Company Overview - Iovance Biotherapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for melanoma and other solid tumor cancers [3]. - The company launched its key melanoma treatment, Amtagvi, in February 2024, administered at authorized treatment centers (ATCs) [3]. Allegations and Issues - The lawsuit alleges that Iovance misrepresented the effectiveness of its ATCs as a driver of demand for Amtagvi, while in reality, these centers faced long timelines for patient treatment and high patient drop-off rates due to ineffective patient identification and selection [4]. - Following disappointing financial results for Q1 2025, Iovance revised its full-year 2025 revenue guidance, citing slow treatment timelines and high patient drop-off as contributing factors [5]. Stock Performance - On May 8, 2025, Iovance's stock price fell over 44%, dropping from $3.17 per share to $1.75 per share the following day, in response to the negative news regarding its financial performance and operational challenges [6].

Core Viewpoint - A class action lawsuit has been filed against Iovance Biotherapeutics, Inc. concerning allegations of securities fraud and unlawful business practices [2][4]. Financial Performance - Iovance reported a total product revenue of $49.3 million for Q1 2025, down from $73.7 million in the previous quarter, indicating a significant decline [4]. - The company revised its full fiscal year 2025 total product revenue guidance from a range of $450 million - $475 million to $250 million - $300 million, representing a reduction of over 40% at the midpoint [4]. - The updated revenue forecast reflects recent launch dynamics affecting Amtagvi, the company's lead product candidate, and considers growth trajectories and treatment timelines for new authorized treatment centers (ATCs) [4]. Stock Market Reaction - Following the financial results announcement, Iovance's stock price fell by $1.42 per share, or 44.79%, closing at $1.75 per share on May 9, 2025 [4].

NEW YORK, June 30, 2025 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) securities between May 9, 2024 and May 8, 2025, both dates inclusive (the "Class Period"), of the important July 14, 2025 lead plaintiff deadline.So What: If you purchased Iovance securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.What to do nex ...

Core Viewpoint - The Gross Law Firm is notifying shareholders of Iovance Biotherapeutics, Inc. regarding a class action lawsuit due to alleged misleading statements and a significant stock price decline following disappointing financial results [1][2]. Group 1: Allegations and Financial Performance - The class period for the allegations is from May 9, 2024, to May 8, 2025, during which Iovance allegedly provided overly positive statements while concealing material adverse facts about its growth potential [2]. - On July 25, 2024, Iovance announced its Q2 fiscal 2024 results and reduced its revenue guidance for the full fiscal year 2024, attributing this to maintenance issues, lower-than-expected Proleukin sales, and a variable pace of treatment initiation [2]. - Following the announcement, Iovance's stock price plummeted from $3.17 per share on May 8, 2025, to $1.75 per share on May 9, 2025, marking a decline of approximately 44.795% in one day [2]. Group 2: Next Steps for Shareholders - Shareholders are encouraged to register for the class action by July 14, 2025, to participate in the case without any cost or obligation [3]. - Registered shareholders will be enrolled in a portfolio monitoring system to receive updates on the case's progress [3]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights against deceit and fraud, ensuring companies adhere to responsible business practices [4].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of Iovance Biotherapeutics, Inc. during the specified Class Period of the upcoming lead plaintiff deadline on July 14, 2025, for a class action lawsuit [1][2] Group 1: Class Action Details - The class action lawsuit claims that during the Class Period, Iovance made false and misleading statements regarding the effectiveness of new Authorized Treatment Centers (ATCs) in treating patients with Amtagvi, leading to higher costs and lower revenue [3] - The lawsuit alleges that the delays in treatment timelines and ineffective patient identification by Iovance's sales team resulted in increased patient drop-offs, which negatively impacted the company's financial performance [3] Group 2: Legal Representation - Investors are encouraged to select qualified legal counsel with a proven track record in securities class actions, as many firms may not have the necessary experience or resources [4] - The Rosen Law Firm has a history of successful settlements in securities class actions, having recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4]

Core Insights - Biotechnology stocks, with exceptions like Novo Nordisk and Eli Lilly, faced challenges in attracting investment capital in 2024 due to a high interest rate environment [1] - The FDA's cautious approach to drug approvals, particularly in breakthrough areas like gene therapy, has impacted large-cap drug companies [2] - The biotech industry is leveraging AI to enhance efficiencies and accelerate drug development, particularly in precision medicine [3] Company-Specific Insights - **Iovance Biotherapeutics**: Received FDA approval for Amtagvi, the first TIL therapy for solid tumors, transitioning from clinical stage to revenue generation. However, the stock is down 75.8% in 2025, with concerns over slow sales and cash burn projected at $300 million for the year [5][6][8] - **Neurocrine Biosciences**: Projecting revenue between $2.5 billion and $2.6 billion in 2025 from its Ingrezza therapy. The approval of Crenessity for congenital adrenal hyperplasia could boost revenue significantly, with peak U.S. sales estimated at $800 million to $1 billion [9][10][11] - **Viking Therapeutics**: Stock is down 33% as it awaits Phase 2 results for its GLP-1 candidate VK2735. The company faces competition from Eli Lilly and has significant short interest, but claims of durable weight loss could provide a competitive edge [13][14][15]