Month: March 2023

Broad response demonstrated through deep cyclic inhibition of MAPK pathway, independent of specific RAS mutation Phase 1/2a clinical trial with IMM-1-104 underway in patients with advanced solid tumors harboring RAS mutations CAMBRIDGE, Mass., March 05, 2023 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, announced today that it will be presenting preclinical data on its lead program IMM-1-104 at the American Association for Cancer Research (AACR) special conference targeting RAS, held March 5-8, 2023, in Philadelphia. The data shows response to IMM-1-104 across a diverse panel of RAS mutant preclinical models, regardless of mutation position or amino acid substitution,...

Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023 TOKYO and CAMBRIDGE, Mass., March 05, 2023 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional...

Nuvei is enabling eCommerce businesses in the world’s 12th largest economy to accelerate their growth MONTREAL, March 05, 2023 (GLOBE NEWSWIRE) — Nuvei Corporation (“Nuvei” or the “Company”) (Nasdaq: NVEI) (TSX: NVEI), the Canadian fintech company, announces today that businesses operating in Australia can now access its full suite of market-leading payments solutions including acquiring, processing, alternative payment methods and risk management. Australian businesses operating locally and globally will benefit from Nuvei’s cutting-edge, agile technology that’s built to accelerate their growth. Nuvei’s payments platform enables businesses to optimize operating costs and boost conversion rates by maximizing payments acceptance, minimizing risk, and enhancing the consumer payment experience. This includes offering all local and...

Oral Presentation Highlighting Data on 15 Subjects from OraGrowtH212 Trial Supportive of Conclusions from Interim Data Analysis Baseline Characteristics of OraGrowtH210 Trial Subjects Highlighted in Poster Presentation AUSTIN, Texas, March 05, 2023 (GLOBE NEWSWIRE) — Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, announced today that additional data from its OraGrowtH212 trial was included in an oral presentation of interim results at the 2023 International Meeting of Pediatric Endocrinology (IMPE), held in Buenos Aires, Argentina, March 4-7, 2023. Data from the interim analysis of its OraGrowtH210 trial are also being presented as a poster during the conference. “The additional data presented at...

–Post-Hoc Analysis Shows IPE Significantly Reduced Risk of First, Total Ischemic Events by 37% and 36% Respectively in Patients with Recent ACS Without Increased Bleeding– –Analysis Builds on Consistently Demonstrated Positive Outcomes for VASCEPA/VAZKEPA Across Sub-Populations in REDUCE-IT, Including in Patients with Prior Myocardial Infarction (MI), Prior Revascularization, Prior Peripheral Arterial Disease (PAD) and Diabetes– DUBLIN, Ireland and BRIDGEWATER, N.J., March 05, 2023 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced a new analysis from the VASCEPA/VAZKEPA (icosapent ethyl) cardiovascular outcomes REDUCE-IT study showing the effectiveness of VASCEPA®/VAZKEPA® in patients with recent acute coronary syndrome (

SHANGHAI, China, March 05, 2023 (GLOBE NEWSWIRE) — GDS Holdings Limited (“GDS Holdings”, “GDS” or the “Company”) (NASDAQ: GDS; HKEX: 9698), a leading developer and operator of high-performance data centers in China, today announced that it will report its fourth quarter and full year 2022 unaudited financial results after the close of the Hong Kong market and before the open of the U.S. market on March 15, 2023. The Company’s management will host an earnings conference call at 8:00 AM U.S. Eastern Time on Wednesday, March 15, 2023 (8:00 PM Hong Kong Time on the same day). Participants should complete online registration using the link provided below at least 15 minutes before the scheduled start time. Upon registration, participants will receive the conference call access information, including dial-in numbers, a personal PIN and...

Lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with uncontrolled hypertension Obesity was predictive of an enhanced response to lorundrostat with placebo-adjusted systolic BP reduction of 16.7 mmHg with 50mg once-daily dosing Additional clinical trial expected to begin in first half of 2023 RADNOR, Pa., March 04, 2023 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced positive data from the Target-HTN Phase 2 study that demonstrated clinically meaningful blood pressure reduction with once-daily dosing of lorundrostat at the American College of Cardiology’s 72nd Annual Scientific Session together with the World Congress of Cardiology...

– Post hoc analysis data demonstrated pegozafermin treatment significantly reduced triglycerides and other atherogenic lipids in patients with SHTG regardless of their background lipid-modifying therapy status – SAN FRANCISCO, March 04, 2023 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the presentation of additional data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia (SHTG) at the American College of Cardiology’s 72nd Annual Scientific Session & Expo Together with World Congress of Cardiology (ACC.23/WCC). The presentation featured results of a post hoc analysis exploring the effect of pegozafermin...

Statistically significant reduction in the risk for the primary outcome on Day 27 Findings generally consistent across the left ventricular ejection fraction (LVEF) range THE WOODLANDS, Texas, March 04, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced new analyses of results from the SOLOIST-WHF Phase 3 outcomes study of its investigational product sotagliflozin presented at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology in New Orleans, Louisiana. The “Time to Clinical Benefit of Sotagliflozin in People with Worsening Heart Failure in SOLOIST-WHF” post hoc analysis examined the timing of clinical benefit of sotagliflozin, defined as the first day post randomization when the hazard ratio (HR) for risk for...

Results Demonstrate Significant Reductions in LDL-C, hsCRP and Cardiovascular Risk in Patients Who Are Unable to Maximize or Tolerate a Statin – NEXLETOL Significantly Reduced Risk of Major Adverse Cardiovascular Events (MACE-4) and (MACE-3) by 13% (P=0.004) and 15% (P=0.006), Respectively, and Significantly Reduced Risk of Myocardial Infarction by 23% (P=0.002) and Coronary Revascularization by 19% (P=0.001) – – CLEAR Outcomes Demonstrated Superior Cardiovascular Outcomes Benefits Compared with Other Oral Non-Statin Therapies and Broader Outcomes Benefits in Primary and Secondary Prevention Compared with PCSK9 inhibitors Whose Outcomes Studies Were Limited to Only Secondary Prevention –  – Detailed Results Simultaneously Published in the New England Journal of Medicine and Presented at ACC.23/WCC –  – Anticipate Regulatory Filings in...