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]

Key Takeaways ABBV is expanding its pipeline with over 20 early-stage deals across immunology, oncology and neuroscience. The $2.1 billion Capstan deal adds a first-in-class CAR-T therapy and proprietary RNA delivery platform. Acquisitions of ImmunoGen and Cerevel have diversified ABBV's portfolio across multiple therapeutic areas.AbbVie (ABBV) has been actively ramping up its deal-making efforts lately, thereby strengthening its pipeline. While immunology remains its core area, the company is also signin ...

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 ...

Together, Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven add 30 satellite locations to enroll patients in BriaCell’s pivotal Phase 3 studyBriaCell’s Phase 3 study currently has 58 active clinical sites across 15 states, including Smilow Cancer Hospital, Los Angeles Cancer Network, University of Arizona, DHR Health Oncology Institute, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hema ...

Tuesday, July 1, 2025Markets were mixed on this first trading day of July, kicking off a holiday-shortened week. Off successive all-time closing highs on the S&P 500 and Nasdaq, both took a breather: -0.11% and -0.82%, respectively. The blue-chip Dow and small-cap Russell 2000, however, were able to catch up somewhat: +0.91% and +0.94%, respectively.This was about as clear-cut and regimented a rotation play as we are likely to see: on the first day of the second half of 2025 (2H25), tech stocks lagged after ...

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, ...

LAUSANNE, Switzerland, July 1, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that the Company has made grants of options to purchase an aggregate of 17,000 of the Company's common shares to one new employee on July 1, 2025 (each, a "Grant").The Grants were offered as material inducement to the employees' employment. The grants were approved by the Compensation Committee of the Company's Boa ...

LOS ANGELES, July 01, 2025 (GLOBE NEWSWIRE) -- Glancy Prongay & Murray LLP reminds investors of the upcoming August 11, 2025 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired Rocket Pharmaceuticals, Inc. (“Rocket” or the “Company”) (NASDAQ: RCKT) securities between February 27, 2025 and May 26, 2025, inclusive (the “Class Period”). IF YOU SUFFERED A LOSS ON YOUR ROCKET INVESTMENTS, CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING CL ...

Core Viewpoint - A class action lawsuit has been filed against Sarepta Therapeutics, Inc. for misleading statements regarding the safety and efficacy of its gene therapy product, ELEVIDYS, during the specified Class Period from June 22, 2023, to June 24, 2025 [1][5]. Group 1: Lawsuit Details - The lawsuit claims that Sarepta made false and misleading statements about ELEVIDYS, which is intended for patients with Duchenne muscular dystrophy, including significant safety risks and failure to detect severe side effects [5]. - It is alleged that the adverse events from ELEVIDYS treatment would lead to a halt in recruitment and dosing in trials, attract regulatory scrutiny, and increase risks around the therapy's approvals [5]. - Investors are encouraged to join the class action to seek compensation without upfront costs through a contingency fee arrangement [2][3]. Group 2: Legal Representation - The Rosen Law Firm, known for its success in securities class actions, is representing the investors and has a strong track record, including recovering hundreds of millions for investors [4]. - Investors are advised to select qualified legal counsel with a proven history in similar cases, as not all firms have comparable experience or resources [4]. Group 3: Next Steps for Investors - Interested investors can join the class action by visiting the provided link or contacting the law firm directly for more information [3][6]. - It is noted that no class has been certified yet, and investors may choose to remain absent or select their own counsel [7].