European Alliance

Monte Rosa Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update

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목요일, 5월 9, 2024
Transfer, FDA, Research, Inflammation, Cell cycle, IND, CNS, Prostate cancer, AACR, Cancer, Autoimmunity, Lung cancer, Traffic barrier, MGD, Food, European Alliance, Conference, Roche, DDW, Pericarditis, Therapy, NSCLC, Rat, Ulcerative colitis, Poster, NLRP3, CCNE1, SCLC, Finance, Triple-negative breast cancer, Consultant, Public expenditure, Obesity, Gout, GLP, DSM-IV codes, Clinical trial, Toxicology, CDK2, G&A, Investigational New Drug, MYC, Research and development, EULAR, Carcinoma, Administration, Rheumatoid arthritis, Neoplasm, POC, Dermatology, Growth, Pharmaceutical industry

“We’re excited by the significant advances made across our entire portfolio, including both our oncology and immunology/inflammation programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics.

Key Points: 
  • “We’re excited by the significant advances made across our entire portfolio, including both our oncology and immunology/inflammation programs,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics.
  • The Company is on track to determine the recommended Phase 2 dose (RP2D) in Q2 2024 and report Phase 1 study results in H2 2024.
  • Announce the recommended Phase 2 dose for the MRT-2359 Phase 1/2 study in Q2 2024 and report Phase 1 clinical results in H2 2024.
  • Net Loss: Net loss for the first quarter of 2024 was $32.0 million, compared to $33.3 million for the fourth quarter of 2023.

OncoOne Announces Formation of Clinical Advisory Board to Support Development of ON104 for Chronic Inflammatory Diseases

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화요일, 3월 12, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Other Health, European Alliance, United, United Nations, Asthma, AAP, Yale school, CD74, Hôpital Cochin, Trinity College Dublin, Arthritis & Rheumatology, Molecular medicine, Cancer, University, Publication, Medical school, ASCI, Prognosis, Trinity, Pathology, Diagnosis, Public health, Trinity College, Arthritis, Physiology, Biomarker, Global Health, Nephritis, Society, EULAR, Inflammatory bowel disease, Physician, Pharmaceutical industry

OncoOne , a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104.

Key Points: 
  • OncoOne , a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104.
  • ON104 is a monoclonal antibody targeting the oxidized isoform of the macrophage migration inhibitory factor (oxMIF) for the treatment of chronic inflammatory diseases.
  • His research focuses on arthritis and other inflammatory rheumatic diseases, precision medicine, and the management of complex diseases.
  • Dr. Freissmuth is an inaugural member of OncoOne’s scientific advisory board, where he continues to support the development of the company’s pipeline of biotherapeutics.

Revvity Launches EONIS Q System Enabling Faster, Simplified Newborn Screening for SMA and SCID

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월요일, 11월 27, 2023
Technology, Biotechnology, Health, Neurology, Consumer, Pharmaceutical, Stem Cells, Other Science, Medical Devices, Software, Managed Care, Baby, Maternity, Health Technology, Science, Infant, European Alliance, Disease, Birth, PCR, Heart, Laboratory, CE, Workflow, Child, SCID, SMA, Real-time, Life, Pharmaceutical industry

The EONIS Q system simplifies and streamlines molecular testing for SMA and SCID with an innovative workflow, inclusive of the EONIS™ Q96 instrument, the EONIS™ SCID-SMA kit and dedicated EONIS™ EASI™ software.

Key Points: 
  • The EONIS Q system simplifies and streamlines molecular testing for SMA and SCID with an innovative workflow, inclusive of the EONIS™ Q96 instrument, the EONIS™ SCID-SMA kit and dedicated EONIS™ EASI™ software.
  • Compared to other methods, the EONIS Q system uses fewer consumables and one-time use plasticware, further optimizing resource and cost efficiencies for labs looking to adopt the system.
  • The European Alliance for Newborn Screening in Spinal Muscular Atrophy (“SMA”), an advocacy group established by SMA Europe, mandates that by 2025, all newborns in Europe should be screened for SMA.
  • The CE-IVD declaration of the EONIS Q system and other solutions like it advance progress toward achieving this goal.

Aurinia Response in Support of 2023 Updated EULAR Recommendations for Management of Lupus and New Treatment Paradigm for Lupus Nephritis

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목요일, 10월 26, 2023
Health, Other Science, Research, Pharmaceutical, Science, Biotechnology, EULAR, SLE, Steroid, European Alliance, Lupus nephritis, Patient, Glomerular filtration rate, Maintenance, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., EGFR, European Alliance of Associations for Rheumatology, Dietary supplement, Pharmaceutical industry, Rheumatology, Aurinia

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia welcomes the 2023 updated recommendations from The European Alliance of Associations for Rheumatology (EULAR) for the management of systemic lupus erythematosus (SLE) based on emerging new evidence, including a new treatment paradigm for lupus nephritis (LN).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia welcomes the 2023 updated recommendations from The European Alliance of Associations for Rheumatology (EULAR) for the management of systemic lupus erythematosus (SLE) based on emerging new evidence, including a new treatment paradigm for lupus nephritis (LN).
  • The new recommendations suggest that in addition to traditional anchor drugs, therapies including LUPKYNIS® (voclosporin) should be considered for any active class of lupus nephritis.
  • “Aurinia appreciates EULAR’s thoughtful consideration for improving the management of lupus nephritis with recommendations that reflect therapeutic advancements in this underserved patient population.
  • The updated recommendations reflect the growing recognition of the clinical value that a therapy like voclosporin provides to people living with lupus nephritis.

Owens Corning Delivers Net Sales of $2.5 Billion; Generates Net Earnings of $337 Million and Adjusted EBIT of $518 Million

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수요일, 10월 25, 2023
Residential Building & Real Estate, Manufacturing, Commercial Building & Real Estate, Construction & Property, Building Systems, Other Manufacturing, Owens Corning, National Centers for Environmental Information, EBITDA, European Alliance, Composite, Glass, Maintenance, EBIT, Responsibility, America's Top 10, Growth, Partnership, Alliance to Save Energy, CFO, Safety, Shingles, Investment, RIR, Fine chemical

Owens Corning continues to invest in accelerating new product and process innovation to support customers and generate additional growth.

Key Points: 
  • Owens Corning continues to invest in accelerating new product and process innovation to support customers and generate additional growth.
  • The company paid a quarterly cash dividend of $47 million and repurchased 1.0 million shares of common stock for $140 million.
  • EBIT increased $114 million to $343 million, expanding EBIT margins to 32% and EBITDA margins to 33%.
  • EBIT decreased $46 million to $80 million while delivering 14% EBIT margins and 22% EBITDA margins.

Selecta Biosciences Reports Second Quarter 2023 Financial Results and Updates on Strategic Initiative Designed to Maximize Stockholder Value Associated with SEL-212 Economics

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목요일, 8월 17, 2023
Partnership, Swedish Orphan Biovitrum, Astellas Pharma, Serum, Telephone, Investigational New Drug, Immunoglobulin A, Antibody, AAV, Congress, Development, Methylmalonic acidemia, Selecta, IgA nephropathy, Investment, European, Administration, Immunoglobulin G, European Alliance of Associations for Rheumatology, EULAR, Research, BLA, Gout, European Alliance, Combination, Pharmaceutical industry, Vaccine, Rheumatology, Patient

WATERTOWN, Mass., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today reported financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • As part of this initiative, the Company plans to:
    Continue to Advance SEL-212 in Patients with Chronic Refractory Gout in Partnership with Sobi.
  • The decrease was primarily the result of the capital prioritization initiative that was enacted in the second quarter of 2023.
  • Net (Loss) Income: For the second quarter of 2023, Selecta reported net loss of $11.4 million, or basic net loss per share of $(0.07).
  • Selecta’s management will host a conference call at 8:30 AM ET today to provide a corporate update and review the Company’s second quarter 2023 financial results and strategic updates.

Kezar Life Sciences Reports Second Quarter 2023 Financial Results and Provides Business Update

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목요일, 8월 10, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Total, KCR, European Renal Association, Autoimmune hepatitis, Week, Cohort, European Alliance of Associations for Rheumatology, Pharmacokinetics, AIH, G&A, ERA, Congress, CRR, Patient, NKF, National Kidney Foundation, ALT, KZR, EULAR, AST, Safety, European Alliance, UPCR, PANLAR, Pharmaceutical industry, Rare-earth element, Vaccine, Rheumatology, LN

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune mediated and oncologic disorders, today reported financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune mediated and oncologic disorders, today reported financial results for the second quarter ended June 30, 2023 and provided a business update.
  • The complete MISSION Phase 1b/2 results were presented as an oral presentation at the LUPUS & KCR 2023 meeting, which took place May 17-20, 2023 in Seoul, Korea.
  • Research and development expenses for the second quarter of 2023 increased by $9.7 million to $21.0 million compared to $11.3 million in the second quarter of 2022.
  • General and administrative (G&A) expenses for the second quarter of 2023 increased by $0.8 million to $5.8 million compared to $5.0 million in the second quarter of 2022.

Patients with Moderate-to-Severe SLE are Increasingly Being Treated with Biologic Therapies Such as GSK’s Benlysta and AstraZeneca’s Saphnelo, According to Spherix Global Insights

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목요일, 6월 15, 2023
NASA RealWorld-InWorld Engineering Design Challenge, JAK, European Alliance of Associations for Rheumatology, Hope, Research, SLE, Patient, Lupus nephritis, Steroid, EULAR, Health, European Alliance, Skin, Pharmaceutical industry, Medical device, EU, Rheumatology

However, recently approved lupus therapies and a robust pipeline offer new hope for treating this heterogenous disease.

Key Points: 
  • However, recently approved lupus therapies and a robust pipeline offer new hope for treating this heterogenous disease.
  • According to the third annual RealWorld Dynamix™ SLE (US) research – which examined 1,011 moderate-to-severe SLE patient charts collected in collaboration with 297 US rheumatologists – major shifts in the treatment of moderate-to-severe SLE are underway.
  • Last year, Spherix expanded their research capabilities offered in SLE with the addition of RealWorld Dynamix™ SLE (EU), capturing patient-level data from this rapidly evolving landscape.
  • The 2023 SLE EU chart audit will be published later this year.

Patient Data Presented at 2023 EULAR Congress Highlights How Serum CCL24 Levels Can Predict Vascular and Fibrotic Complications of Systemic Sclerosis

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금요일, 6월 2, 2023
CCL24, University, Therapy, Serum, European Alliance of Associations for Rheumatology, CMMB, ILD, Prognosis, Primary sclerosing cholangitis, Scleroderma, Doctor of Philosophy, TEL, Incidence, Congress, Patient, European, DSM-IV codes, Risk, Poster, R, EULAR, European Alliance, Systemic scleroderma, Disease, Pharmaceutical industry, Rheumatology

MILAN and TEL AVIV, Israel, June 2, 2023 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced a poster presentation at the 2023 European Congress of Rheumatology, hosted by the European Alliance of Association for Rheumatology (EULAR) and held in Milan, Italy May 31–June 3, 2023.

Key Points: 
  • The poster, "CCL24 serum concentration predicts both vascular and fibrotic complications in systemic sclerosis," was presented today by Professor Enrico De Lorenzis of the Leeds Institute of Rheumatic and Musculoskeletal Diseases at the University of Leeds in the UK.
  • The study was conducted by Professor De Lorenzis and his colleagues who enrolled systemic sclerosis (SSc) patients from an observational cohort and compared them with age- and gender-matched controls.
  • 1 - CCL24 serum concentration predicts both vascular and fibrotic complications in systemic sclerosis, Enrico De Lorenzis, Adi Mor, Rebecca Ross, Stefano Di Donato, Revital Aricha, Hilit Levi, Ilan Vaknin, Francesco Del Galdo
    A copy of the poster will be available at the R&D portion of Chemomab's website.
  • For more information on the EULAR Congress, visit https://congress.eular.org/

Selecta Biosciences Announces Presentation of Data from Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout During Late-Breaking Session at the EULAR 2023 European Congress of Rheumatology

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수요일, 5월 31, 2023
Biologics license application, MACR, European Alliance of Associations for Rheumatology, FACP, Immune tolerance, WHO-convened Global Study of Origins of SARS-CoV-2, Disability, Congress, Patient, European, EULAR, Principal, George Washington University, Chronic pain, European Alliance, BLA, Pharmaceutical industry, Palladium, Rheumatology, Medicine

WATERTOWN, Mass., May 31, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today announced the presentation of positive data from the Phase 3 DISSOLVE I and DISSOLVE II double-blind, placebo-controlled studies of SEL-212 in patients with chronic refractory gout. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase). The data were featured during a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2023 European Congress of Rheumatology being held May 31 – June 3 in Milan, Italy.

Key Points: 
  • SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
  • The data were featured during a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2023 European Congress of Rheumatology being held May 31 – June 3 in Milan, Italy.
  • The response rate in the high dose group was 56% in DISSOLVE I and 46% in DISSOLVE II.
  • A copy of the presentation will be available in the Resources section of Selecta’s website, http://www.selectabio.com/.