Month: April 2024

– Patients With Obesity Who Took NEXLETOL Were 23% Less Likely to Experience a Major Adverse Cardiovascular Event (MACE-4) Compared to Placebo – – NEXLETOL Demonstrated Clinical Benefit in Historically Underrepresented Groups: Women and Hispanic/Latinx Patients With and Without Cardiovascular Disease (CVD) – – CLEAR Outcomes Sets New Standards for Diversity and Inclusion with Enrollment of 48% Women and 17% Hispanic/Latinx Patients – ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) — Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion...

Three-year follow-up data of an investigator-initiated Phase 1 trial of the individualized mRNA cancer vaccine candidate autogene cevumeran (BNT122, RO7198457) continue to show polyspecific T cell responses up to three years and delayed tumor recurrence in patients with resected pancreatic ductal adenocarcinoma (“PDAC”) A randomized Phase 2 clinical trial with autogene cevumeran in patients with resected PDAC is currently enrolling patients at clinical trial sites in the United States, with additional sites planned to open globally The medical need in PDAC is high with a 5-year overall survival rate of only 8-10%1,2, high recurrence rates after surgery at nearly 80%3 and limited treatment options Autogene cevumeran, jointly developed by BioNTech and Genentech Inc. (“Genentech”), a member of the Roche Group, is the lead candidate of BioNTech’s...

– In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression – The data demonstrate that targeting near-complete transthyretin (TTR) stabilization with acoramidis may enable cardiac remodeling and functional recovery in patients with ATTR-CM – These results are the first prospective, longitudinal evaluation of cardiac structure and function by CMR imaging in a double-blind, placebo-controlled, interventional study in ATTR-CM – The findings from this study build upon positive results from BridgeBio’s global ATTRibute-CM Phase 3 trial, wherein the primary endpoint was met (Win Ratio of 1.8) with a high statistical significance (p

SHANGHAI, China, April 07, 2024 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for toripalimab (product code: JS001) in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (“RCC”). This is the first approved immunotherapy for renal carcinoma in China. Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma. There were approximately 77,000...

GUANGZHOU, China, April 07, 2024 (GLOBE NEWSWIRE) — EHang Holdings Limited (“EHang” or the “Company”) (Nasdaq: EH), the world’s leading Urban Air Mobility (“UAM”) technology platform company, today announced that EHang has successfully obtained the Production Certificate (“PC”) for its EH216-S passenger-carrying pilotless electric vertical takeoff and landing (“eVTOL”) aircraft issued by the Civil Aviation Administration of China (“CAAC”), which is the world’s first PC granted in the global eVTOL industry. Following the groundbreaking obtaining of the Type Certificate (“TC”) and the Standard Airworthiness Certificate (“AC”) for the EH216-S, this remarkable achievement is another significant leap towards mass production for the eVTOL aircraft and the following commercial operations. The PC granting ceremony was held at the International...

Oslo, 7 April 2024  Reference is made to the Extraordinary General Meeting(“EGM”) held in Ensurge Micropower ASA (the “Company”) on 10 November 2023 whereby the EGM resolved to issue convertible loans with total par value of NOK 4,500,000 (the “Convertible Loans”), whereby the Convertible Loans, plus accrued interest, were convertible into shares prior to the maturity date at a conversion price of NOK 0.105 per share (NOK 0.525 following the share consolidation approved by the Extraordinary General Meeting on 19 March 2024, which became effective on 5 April 2024).  The lender of an aggregated total of NOK 1,500,000 of the Convertible Loan, has provided its notification of conversion to the Company and requested that its part of the Convertible Loan, plus accrued interest, is converted into shares in...

V-INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively)1A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment1Results from usual care arm reinforce the urgent need for more aggressive LDL-C lowering in ASCVD patients, 92% of whom did not reach their LDL-C goal with statins alone1The Leqvio safety profile was consistent with the Phase III clinical studies and long-term open-label extension trials for up to 6 years of treatment1-4Basel, April 6, 2024 – Novartis today announced new...

— Findings Presented on VASCEPA/VAZKEPA Utility in REDUCE-IT Patient Subgroups by Baseline High/Low Lp(a), LDL-C Levels — — Lp(a) Results Published Simultaneously in the Journal of the American College of Cardiology (JACC) – DUBLIN, Ireland and BRIDGEWATER, N.J., April 06, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today highlighted two data presentations at ACC.24 describing the effects of VASCEPA®/VAZKEPA® (icosapent ethyl) on reducing MACE (Major Adverse Cardiovascular Events) in patients with baseline high or low Lipoprotein(a) [Lp(a)] levels, as well as reducing the risk of cardiovascular (CV) events in patients irrespective of baseline LDL-C level. The REDUCE-IT analysis results relating Lp(a) concentrations with CV risk were also published online today in the Journal of the American College...

Phase 2 data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p