NEW YORK, July 02, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT). Shareholders who purchased shares of RCKT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/rocket-pharmaceuticals-inc-loss-submission-form/?id=155081&from=3 CLA ...

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].

NEW YORK, July 02, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT). Shareholders who purchased shares of SRPT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/sarepta-loss-submission-form/?id=155065&from=3 CLASS PERIOD: June 22, 2 ...

Core Viewpoint - Investors in Rocket Pharmaceuticals, Inc. have the opportunity to lead a securities fraud class action lawsuit due to substantial losses incurred [1][2]. Group 1: Lawsuit Details - The lawsuit alleges that from February 27, 2025, to May 26, 2025, Rocket Pharmaceuticals failed to disclose significant risks, including serious adverse events (SAEs) such as participant deaths in clinical studies [3]. - The complaint states that Rocket amended the trial protocol to include a new immunomodulatory agent without informing shareholders, leading to misleading positive statements about the company's operations and prospects [3]. Group 2: Participation Information - Investors who suffered losses in Rocket Pharmaceuticals are encouraged to contact the Law Offices of Howard G. Smith before August 11, 2025, to participate in the ongoing lawsuit [2][4]. - Individuals interested in learning more about the class action or their rights can reach out to the law firm via email or phone [4][5].

Core Insights - I-Mab announced positive Phase 1b combination data for givastomig, showing a confirmed objective response rate (ORR) of 83% at selected doses for ongoing expansion studies [1][2][3] - The study demonstrated favorable tolerability and safety profile, with no Grade 3 or greater events for nausea and vomiting [2][21] - Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB, being developed for first-line treatment of Claudin 18.2-positive gastric cancers [15][18] Study Results - The Phase 1b study showed an overall ORR of 71% across all doses and 83% at doses selected for expansion (8 mg/kg and 12 mg/kg) [2][10] - Responses were observed in tumors with low PD-L1 and/or Claudin 18.2 expression, indicating broad potential for the therapy [2][3] - The disease control rate (DCR) was 100% across all dose levels, with a median follow-up of 9.0 months [12][13] Safety Profile - Treatment-related adverse events (TRAEs) leading to discontinuation were 12%, with common TRAEs being Grade 1 or 2 [21] - No dose-limiting toxicities (DLT) were observed, and a maximum tolerated dose (MTD) was not reached [21] - Grade 3 TRAEs were rare, with only isolated cases reported [21] Future Plans - I-Mab plans to host a virtual investor event on July 8 to discuss the Phase 1b data further [1][4] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [16][18]

TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Lynozyfic was granted accelerated approval bas ...

Financial Position & Pipeline - Cytokinetics had approximately $1.1 billion in cash, cash equivalents, and investments as of March 31, 2025[9] - Cytokinetics has further access to capital, including up to $275 million in term loan facilities with Royalty Pharma[176] - Royalty Pharma has the option to invest up to $150 million in a Phase 3 trial of CK-586 in exchange for an additional 3.5% revenue participation interest in worldwide net sales of CK-586[9, 176] - 2025 GAAP operating expense is guided to be between $670 million and $710 million, including $110 million to $120 million in stock-based compensation[178] Aficamten Program - The U S PDUFA date for aficamten is December 26, 2025, with China NDA and EU MAA on file[8, 92, 181] - Positive topline results from MAPLE-HCM demonstrated superiority of aficamten to metoprolol in patients with obstructive HCM[96, 99, 181] - SEQUOIA-HCM pivotal Phase 3 trial enrolled 282 patients with oHCM treated with standard of care[42] - SEQUOIA-HCM showed a statistically significant improvement in exercise capacity compared to placebo, with a least squares mean difference of 1 74 mL/kg/min (p=0 000002)[46, 47] - In the SEQUOIA-HCM CMR sub-study, aficamten was associated with a significant improvement in Left Ventricular Mass Index (LVMI) of -15 4 g/m2 (p=0 001)[62, 63] Omecamtiv Mecarbil Program - COMET-HF is a Phase 3 confirmatory clinical trial for omecamtiv mecarbil[128, 181] - The COMET-HF trial is targeting a patient population of approximately 840,000 high-risk heart failure patients with EF<30% in the US[21, 133] CK-586 Program - AMBER-HFpEF is a Phase 2 clinical trial evaluating CK-586 in HFpEF patients with LVEF ≥ 60%[163, 166] - Approximately 84% of HFpEF patients will die within five years of initial hospitalization[143, 144]

Core Insights - AbbVie is actively enhancing its deal-making efforts to strengthen its pipeline, focusing on immunology while also exploring early-stage deals in oncology and neuroscience [2][4] Group 1: Recent Acquisitions - AbbVie signed a definitive agreement to acquire Capstan Therapeutics for nearly $2.1 billion, expected to close in Q3, which will add a first-in-class CAR-T therapy and proprietary RNA delivery platform to its immunology pipeline [3][11] - The company has completed over 20 early-stage deals since last year, including a long-acting amylin analog for obesity from Gubra, marking its entry into the obesity treatment space [4][11] - Recent larger acquisitions include ImmunoGen, adding the ovarian cancer drug Elahere, and Cerevel Therapeutics, diversifying AbbVie's therapeutic portfolio across multiple modalities [5][11] Group 2: Market Context and Competitors - Broader macroeconomic concerns have impacted deal-making, but major pharmaceutical companies continue to pursue strategic assets in key growth areas [7] - Eli Lilly announced its intent to acquire Verve Therapeutics for up to $1.3 billion, marking its third targeted M&A deal this year, indicating a selective M&A strategy focused on long-term strength across therapeutic areas [8] - Sanofi's $9.5 billion acquisition of Blueprint Medicines aims to strengthen its immunology pipeline and reduce reliance on Dupixent, showcasing ongoing consolidation in the industry [9] Group 3: Financial Performance and Valuation - AbbVie shares have outperformed the industry year to date, trading at a P/E ratio of 14.42, slightly below the industry average of 14.86, but higher than its five-year mean of 12.46 [10][13] - The Zacks Consensus Estimate for AbbVie's 2025 EPS has increased from $12.26 to $12.28, while the estimate for 2026 remains at $14.06 [14]

LOS ANGELES, July 2, 2025 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against Sarepta Therapeutics, Inc. ("Sarepta" or "the Company") (NASDAQ: SRPT) for violations of the federal securities laws.Shareholders who purchased the Company's securities between June 22, 2023 and June 24, 2025, inclusive (the "Class Period"), are encouraged to contact the firm before August 25, 2025.CASE DETAILS:  The complaint alleges that the Company made false and misleading statements to the ma ...

Core Insights - BriaCell Therapeutics Corp. is expanding its pivotal Phase 3 clinical study by adding two major cancer centers, Los Angeles Cancer Network and Smilow Cancer Hospital, which will increase patient enrollment capabilities [1][7] - The study is focused on evaluating BriaCell's lead candidate, Bria-IMT™, in combination with an immune checkpoint inhibitor for advanced metastatic breast cancer [2][3] - The company anticipates completing patient enrollment by late 2025 or early 2026, with top line data potentially available in the first half of 2026 [1][3] Clinical Study Details - The Phase 3 study aims to compare overall survival (OS) in patients treated with the Bria-IMT combination regimen against those receiving physician's choice, with 144 patient events (deaths) required for interim data analysis [3] - Positive results from this study could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [3] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential significance in treating this patient population [3] Clinical Site Expansion - With the addition of the two cancer centers, BriaCell's Phase 3 study now has a total of 58 active clinical sites across 15 states [7] - The expanded network includes notable institutions such as the University of Arizona and Northwestern University, enhancing patient access to the study [7]