Day: March 5, 2023

Immuneering Presents Preclinical Data with Lead Program IMM-1-104 Supporting Universal-RAS Activity

Immuneering Presents Preclinical Data with Lead Program IMM-1-104 Supporting Universal-RAS Activity

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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,...

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FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

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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...

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Nuvei announces next step in its global expansion plan with Australia launch

Nuvei announces next step in its global expansion plan with Australia launch

Written by Customer Service on . Posted in Public Companies.

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...

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Additional Data on Lumos OraGrowtH Trials Presented at International Meeting of Pediatric Endocrinology

Additional Data on Lumos OraGrowtH Trials Presented at International Meeting of Pediatric Endocrinology

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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...

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Amarin Announces New REDUCE-IT® Data at ACC.23/WCC Showing Benefit of VASCEPA®/VAZKEPA® (Icosapent Ethyl) in High-Risk Patients with a Recent Acute Coronary Syndrome Event

Amarin Announces New REDUCE-IT® Data at ACC.23/WCC Showing Benefit of VASCEPA®/VAZKEPA® (Icosapent Ethyl) in High-Risk Patients with a Recent Acute Coronary Syndrome Event

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–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 (

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GDS to Report Fourth Quarter and Full Year 2022 Financial Results Before the Open of the U.S. Market on March 15, 2023

GDS to Report Fourth Quarter and Full Year 2022 Financial Results Before the Open of the U.S. Market on March 15, 2023

Written by Customer Service on . Posted in Public Companies.

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...

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