The New England Journal of Medicine

EQS-News: Mainz Biomed Reports Third Quarter 2023 Financial Results and Provides Corporate Update

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Thursday, December 7, 2023
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ColoAlert® Revenue Increases 102% Year Over Year for the Nine Months Ended September 30, 2023

Key Points: 
  • ColoAlert® Revenue Increases 102% Year Over Year for the Nine Months Ended September 30, 2023
    BERKELEY, US – MAINZ, Germany – November 16, 2023 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today financial results of the third quarter ending September 30, 2023 and provided a corporate update.
  • “This past quarter was an important period of progress for the Company highlighted by ColoFuture’s spectacular readout of results.
  • During the quarter, Mainz Biomed established a strategic partnership with Ärztliches Labor Dr. Buhlmann, a respected player in PCR-based analysis.
  • Throughout the third quarter, Mainz Biomed continued to prepare for commencing patient enrollment in the ReconAAsense clinical trial (ClinicalTrials.gov Identifier: NCT05636085).

Historic Victory as People With Diabetes Win Access to Life-Changing Technology, But Almost Half Don’t Understand the Benefits1-2

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Wednesday, November 8, 2023
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Dexcom’s research follows the new Technology Appraisal (TA) from NICE which provides detailed guidance for hybrid closed loop systems usage.

Key Points: 
  • Dexcom’s research follows the new Technology Appraisal (TA) from NICE which provides detailed guidance for hybrid closed loop systems usage.
  • The new TA impacts an eligible population of over 150,000 people living with Type 1 diabetes in England, providing access to HCL systems3.
  • HCL systems powered by Dexcom real-time CGM have been proven to significantly improve outcomes – giving people with diabetes more confidence in their diabetes management4-6, 8-11.
  • The research was conducted by Censuswide with 251 UK healthcare professionals (aged 18+) involved in the care of people with T1 diabetes between 10.10.2023 - 18.10.2023.

Blue Cross and Blue Shield of Minnesota expands no-cost access to Diabetes Prevention Programs, starting in 2024

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Wednesday, November 8, 2023
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EAGAN, Minn., Nov. 8, 2023 /PRNewswire/ -- Blue Cross and Blue Shield of Minnesota (Blue Cross) today announced it is eliminating member cost-sharing for diabetes prevention programs (DPPs) for fully-insured commercial members beginning upon 2024 plan renewals. Traditionally available through Medicare and Medicaid at no cost, DPP benefits in commercial plans often come with a level of out-of-pocket expense for the member. With this change, Blue Cross is lowering the barrier for accessing a national network of support that is proven to help reduce diagnoses of type 2 diabetes.

Key Points: 
  • EAGAN, Minn., Nov. 8, 2023 /PRNewswire/ -- Blue Cross and Blue Shield of Minnesota (Blue Cross) today announced it is eliminating member cost-sharing for diabetes prevention programs (DPPs) for fully-insured commercial members beginning upon 2024 plan renewals.
  • With this change, Blue Cross is lowering the barrier for accessing a national network of support that is proven to help reduce diagnoses of type 2 diabetes.
  • "Increasing accessibility through the elimination of cost sharing is an integral component of our multi-faceted approach to diabetes prevention.
  • The expansion of no-cost DPP programs applies to Blue Cross and Blue Shield of Minnesota's fully insured commercial plans.

Immunocore Reports Third Quarter 2023 Financial Results and Provides Business Update

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Tuesday, November 7, 2023
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& ROCKVILLE, Md., US, 07 November 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • & ROCKVILLE, Md., US, 07 November 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.
  • Commercial sales have increased in the United States and European countries, including France, Germany and Italy, during the third quarter.
  • Since the beginning of 2023, we have launched KIMMTRAK in Austria, Israel, Italy, Finland, Switzerland and Belgium, and have recently reached price agreements with Canada and Australia.
  • Cash and cash equivalents were £364.0 million ($444.5 million) as of September 30, 2023, compared to £332.5 million as of December 31, 2022.

Medical Breakthroughs Reliant on Better Clinical Trials

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Tuesday, November 7, 2023
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MANASSAS, Va. , Nov. 7, 2023 /PRNewswire-PRWeb/ -- The dropout rate for clinical trials has long plagued researchers with evidence indicating that sometimes more than 30% of patient dropout during phase 3 clinical trials.(1) A substantial figure, this reality is detrimental not only to the studies themselves but also to the health and wellbeing of all those who may need but will not receive potentially life altering medical help for their conditions. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, wants clinical trial sponsors and operators to understand what causes these high dropout rates and why it is so important to minimize them. Dr. Rajasimha feels greater remote accessibility for trial participants is key. "We want to make clinical trials universally accessible and more efficient."

Key Points: 
  • MANASSAS, Va. , Nov. 7, 2023 /PRNewswire-PRWeb/ -- The dropout rate for clinical trials has long plagued researchers with evidence indicating that sometimes more than 30% of patient dropout during phase 3 clinical trials.
  • "We want to make clinical trials universally accessible and more efficient."
  • Dr. Rajasimha says the one of the key goals of Sponsors should be to mitigate these risks of patient dropout in clinical trials.
  • "By accelerating the standardized adoption of decentralized clinical trials, Sponsors can achieve efficiency and accessibility for all patients who may seek them.

Travere Therapeutics Announces Late-Breaking Data from Phase 3 Studies of Sparsentan in IgAN and FSGS Published in The Lancet and The NEJM Respectively and Presented at the American Society of Nephrology (ASN) Kidney Week 2023

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Friday, November 3, 2023
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SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced additional data from two pivotal clinical studies demonstrating sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT) and The New England Journal of Medicine (DUPLEX).

Key Points: 
  • Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT ) and The New England Journal of Medicine (DUPLEX) .
  • The absolute overall change in kidney function from baseline to the end of the study for patients treated with FILSPARI was -5.8 mL/min/1.73m2 compared to -9.5 mL/min/1.73m2 with irbesartan.
  • Treatment with FILSPARI demonstrated lower rates of the composite endpoint of 40% decline in eGFR, kidney failure or death compared to irbesartan.
  • Sparsentan showed a consistent and sustained achievement of complete remission of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for irbesartan.

Inari Medical Expands Its Patient-Focused Mission with Agreement to Acquire LimFlow

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Wednesday, November 1, 2023
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IRVINE, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced that it has entered into a definitive agreement to acquire LimFlow, S.A., a privately held pioneer in limb salvage for patients with chronic limb-threatening ischemia (CLTI). Under the terms of the agreement, Inari will pay $250 million in cash at closing and LimFlow will be eligible to receive additional cash payments based on certain commercial and reimbursement milestones. The transaction is expected to close in the fourth quarter of 2023.

Key Points: 
  • Under the terms of the agreement, Inari will pay $250 million in cash at closing and LimFlow will be eligible to receive additional cash payments based on certain commercial and reimbursement milestones.
  • LimFlow has already trained and deployed an initial team of sales representatives in targeted U.S. markets who are executing the launch of the LimFlow therapy.
  • Inari anticipates continuing to expand this team as a focused, dedicated sales force separate from Inari’s existing VTE sales organization.
  • Inari plans to leverage these same capabilities to successfully commercialize the LimFlow System in the United States.

SpringWorks Therapeutics Announces Presentation of Additional Data from Phase 3 DeFi Trial of Nirogacestat in Adults with Desmoid Tumors at the 2023 CTOS Annual Meeting

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Wednesday, November 1, 2023
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STAMFORD, Conn., Nov. 01, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced the presentation of additional data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, being held November 1-4, 2023. These data demonstrate the impact of nirogacestat, an investigational gamma secretase inhibitor, on physical and role functioning in adults with desmoid tumors. Data from the DeFi trial demonstrated statistically significant and clinically meaningful improvements across all primary and key secondary endpoints and were previously presented at leading medical congresses and published in the March 9, 2023 edition of the New England Journal of Medicine.1-3

Key Points: 
  • These data demonstrate the impact of nirogacestat, an investigational gamma secretase inhibitor, on physical and role functioning in adults with desmoid tumors.
  • “We are pleased that the robust data from our Phase 3 DeFi trial demonstrated that nirogacestat provided clinically meaningful improvements in key patient-reported outcomes, including pain as well as both physical and role functioning.
  • Nirogacestat also achieved a significant and clinically meaningful improvement in physical and role functioning status, a key secondary endpoint, compared with placebo at Cycle 10 (p
  • Nirogacestat significantly improved mean physical functioning score from baseline per the EORTC QLQ-C30 PF subscale compared with placebo at the pre-specified time point.

Wolters Kluwer 2023 Nine-Month Trading Update

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Wednesday, November 1, 2023
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Alphen aan den Rijn, November 1, 2023 – Wolters Kluwer, a global leader in professional information, software solutions and services, today releases its scheduled 2023 nine-month trading update.

Key Points: 
  • Alphen aan den Rijn, November 1, 2023 – Wolters Kluwer, a global leader in professional information, software solutions and services, today releases its scheduled 2023 nine-month trading update.
  • Recurring revenues (82% of total revenues) sustained strong momentum, growing 7% organically which was in line with 2022 and in line with the first half of 2023 (9M 2022: 7%; HY 2023: 7%).
  • On August 31, 2023, we cancelled 9.0 million shares that were held in treasury, as approved by shareholders at the AGM in May 2023.
  • In February 2023, we announced a 2023 share buyback program of up to €1 billion.

New England Journal of Medicine Publishes Complete Results of Positive Phase 2 Trial of Sibeprenlimab in Treatment of Immunoglobulin A Nephropathy (IgAN)

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Thursday, November 2, 2023
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View the full release here: https://www.businesswire.com/news/home/20231102845310/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231102845310/en/
    The Phase 2 trial randomized 155 adult participants with biopsy-confirmed IgAN to monthly intravenous injections of sibeprenlimab 2, 4, or 8 mg/kg, or placebo for 12 months.
  • The primary outcome measure was the change from baseline in 24-hour urine protein-to-creatinine ratio (uPCR) at month 12.
  • The annual eGFR change was −2.7, +0.2, −1.5, and −7.4 ml/1.73 m2 with sibeprenlimab 2, 4, and 8 mg/kg, and placebo, respectively.
  • This reflects a stabilization of eGFR with sibeprenlimab compared to the eGFR decline observed with placebo.1
    The incidence of treatment-emergent adverse events (TEAEs) for patients on sibeprenlimab and placebo was similar.