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Rocket Pharmaceuticals, Inc. (RCKT) Investors Who Lost Money Have Opportunity to Lead Securities Fraud Lawsuit
Prnewswire· 2025-07-02 16:00
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].
I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Globenewswire· 2025-07-02 15:15
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]
Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma
Globenewswire· 2025-07-02 15:00
Core Viewpoint - The FDA has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy, marking a significant advancement in treatment options for this patient population [1][5][6]. Group 1: FDA Approval and Clinical Trial Results - Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody, allowing for a flexible dosing schedule that can adapt based on patient response [2][3]. - The approval is based on the LINKER-MM1 trial, where 70% of patients achieved an overall response rate, with 45% achieving a complete response or better [6][5]. - The median time to first response was 0.95 months, and the median duration of response was not reached, with an estimated 89% of responders maintaining their response at 9 months [6][12]. Group 2: Safety and Administration - Lynozyfic has a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, with common adverse reactions including musculoskeletal pain, cough, and fatigue [4][18]. - The treatment involves a step-up dosing regimen, requiring hospitalization for safety during the initial doses [10][20]. - Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS) due to the associated risks [4][22]. Group 3: Company Commitment and Future Development - Regeneron is committed to advancing the treatment landscape for multiple myeloma and has launched Lynozyfic Surround™, providing financial and educational resources for patients [5][6]. - The company is rapidly advancing its clinical development program for Lynozyfic, exploring its use in earlier lines of therapy and in combination with other treatments [5][13]. - Regeneron utilizes its proprietary VelocImmune technology to develop Lynozyfic, showcasing its expertise in creating fully human antibodies [9][17].
Cytokinetics (CYTK) Earnings Call Presentation
2025-07-02 14:16
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]
Will AbbVie's Acquisition Spree Aid Pipeline Growth?
ZACKS· 2025-07-02 13:51
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]
SRPT Shareholders Have the Right to Lead the Sarepta Therapeutics, Inc. Securities Lawsuit - Contact the DJS Law Group Before the Final Deadline - SRPT
Prnewswire· 2025-07-02 13:24
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 ...
BriaCell Highlights Additional Phase 3 Clinical Sites Including Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven
Globenewswire· 2025-07-02 11:30
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]
Trading Rotation Kicks Off 2nd Half of 2025
ZACKS· 2025-07-01 23:11
Market Overview - The stock market experienced mixed results on the first trading day of July, with the S&P 500 and Nasdaq declining by -0.11% and -0.82% respectively, while the Dow and Russell 2000 increased by +0.91% and +0.94% respectively [1] - A rotation occurred in the market, with tech stocks lagging after a strong first half of 2025, while healthcare stocks led, exemplified by Amgen (AMGN) gaining +4% and Merck (MRK) up +3.4% [2] Economic Indicators - The Job Openings and Labor Turnover Survey (JOLTS) for May reported 7.8 million job openings, exceeding expectations of 7.3 million, with job quits at 3.3 million and layoffs/discharges at 1.6 million [4] - The highest job openings were in Accommodation/Food Service (+314K) and Finance/Insurance (+91K), while the Federal Government saw a decrease of -39K jobs [5] - Manufacturing data showed stronger than expected results, with S&P final Manufacturing PMI at 52.9 and ISM Manufacturing at 49.0%, while Construction Spending for May fell to -0.3% [6] Company Performance - Constellation Brands (STZ) reported Q1 earnings of $3.22 per share on revenues of $2.52 billion, missing estimates of $3.38 per share and $2.57 billion, attributed to softer consumer demand in wine and beer sales, with shares down -24% year to date [7]
Cidara Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)
Globenewswire· 2025-07-01 20:59
SAN DIEGO, July 01, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company applying its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the Compensation and Human Capital Committee of its Board of Directors (Compensation Committee) granted non-qualified stock option awards and restricted stock units (RSUs) for an aggregate of 12,100 shares of its common stock to two new employees, pursuant to the Cidara Therapeutics, ...
ADC Therapeutics Makes Grant to New Employee Under Inducement Plan
Prnewswire· 2025-07-01 20:05
Core Points - ADC Therapeutics SA has granted options to purchase 17,000 common shares to a new employee as an inducement for employment [1][2] - The grants were approved by the Compensation Committee under the Company's Inducement Plan to motivate and reward employees [2] - The options will vest 25% on the first anniversary of the grant date and 1/48th monthly thereafter, fully vesting by the fourth anniversary [3] Company Overview - ADC Therapeutics is a global leader in antibody drug conjugates (ADCs) and is focused on transforming treatment for hematologic malignancies and solid tumors [4] - The company's ADC ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma [5] - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [6]