Clinical Trials

Enanta Pharmaceuticals to Host Conference Call on November 20 at 4:30 p.m. ET to Discuss its Financial Results for its Fiscal Fourth Quarter and Full Year Ended September 30, 2023

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Monday, November 13, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Viral, Research, Medication, Pharmaceutical industry, Auction

(NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that it plans to report its financial results for its fiscal fourth quarter and full year ended September 30, 2023 after the U.S. market closes on November 20, 2023.

Key Points: 
  • (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that it plans to report its financial results for its fiscal fourth quarter and full year ended September 30, 2023 after the U.S. market closes on November 20, 2023.
  • Enanta management will host a conference call at 4:30 p.m.
  • ET to discuss these results and provide an update on the company’s business and research and development pipeline.
  • It is recommended that participants register one day in advance or at a minimum of 30 minutes before the call.

Element Science Announces Presentation of Successful Results of the Jewel® IDE Study in a Featured Science Presentation at the American Heart Association’s 2023 Annual Scientific Sessions

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Monday, November 13, 2023
Mobile, Wireless, Other Technology, Other Science, Software, Research, Networks, Internet, Hardware, Electronic Design Automation, Medical Devices, Data Management, Consumer Electronics, Hospitals, Wearables, Mobile Technology, Technology, Clinical Trials, Cardiology, Science, Biotechnology, Telemedicine, Virtual Medicine, Managed Care, General Health, Finance, Health, Artificial Intelligence, Health Technology, Professional Services, Safety, Device, Arrest, Success, Exercise, AHA, Risk, ICD, Patient, Sudden arrhythmic death syndrome, Death, Ventricular tachycardia, WCD, Survival, Health care, Jewel, Physician, Quality of life, American Heart, SCA, Ventricular fibrillation, Medical device, Pharmaceutical industry, Hospital

Element Science , an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, today announced the successful completion and presentation of the results of the Jewel IDE Study.

Key Points: 
  • Element Science , an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, today announced the successful completion and presentation of the results of the Jewel IDE Study.
  • Powered by a proprietary machine learning algorithm, the Jewel P-WCD also accurately detects abnormal heart rhythms resulting in a low false alarm rate and timely defibrillation when needed.
  • Dr. John Hummel, one of the study National Principal Investigators and the presenter of the study results at AHA ’23 stated, “The results of the Jewel IDE Study are extremely encouraging.
  • Element Science has concentrated its efforts on enhancing these patients' survival prospects by utilizing advancements in technology that bolster home-based care.

Legend Biotech Announces Exclusive, Global License Agreement for Certain CAR-T Therapies Targeting DLL3

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Monday, November 13, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Business development, Food, Carcinoma, End-user license agreement, Patient, FDA, Hart–Scott–Rodino Antitrust Improvements Act, DLL3, License, Novartis, Pharmaceutical industry

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that Legend Biotech Ireland Limited, a wholly owned subsidiary of Legend Biotech, has entered into an exclusive, global license agreement (License Agreement) with Novartis Pharma AG for certain Legend Biotech chimeric antigen receptor T-cell (CAR-T) cell therapies targeting DLL3, including its autologous CAR-T cell therapy candidate, LB2102 ( NCT05680922 ).1 The License Agreement grants Novartis the exclusive worldwide rights to develop, manufacture and commercialize these cell therapies, and Novartis may apply its T-Charge™ platform to their manufacture.

Key Points: 
  • Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that Legend Biotech Ireland Limited, a wholly owned subsidiary of Legend Biotech, has entered into an exclusive, global license agreement (License Agreement) with Novartis Pharma AG for certain Legend Biotech chimeric antigen receptor T-cell (CAR-T) cell therapies targeting DLL3, including its autologous CAR-T cell therapy candidate, LB2102 ( NCT05680922 ).1 The License Agreement grants Novartis the exclusive worldwide rights to develop, manufacture and commercialize these cell therapies, and Novartis may apply its T-Charge™ platform to their manufacture.
  • Legend Biotech is initiating clinical development of LB2102 for the treatment of extensive stage small cell lung cancer and large cell neuroendocrine carcinoma after the U.S. Food and Drug Administration (FDA) cleared its investigational new drug application in 2022.
  • “We believe LB2102 has an innovative CAR design and armor mechanism that increases its anti-tumor activity.
  • Under the terms of the License Agreement, Legend Biotech will receive a $100 million upfront payment and will be eligible to receive up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties.

Tune Therapeutics Reveals Epigenetic Editing Program Targeting Hepatitis B Virus

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Monday, November 13, 2023
Biotechnology, Infectious Diseases, Health, Genetics, Clinical Trials, Hepatology, DNA, Therapy, Hepatitis B virus, AASLD, Tune, HBV, Multimedia, Patient, TEMPO, CccDNA, Genome, Standard of care, University, Epigenetics, SOC, Vaccine, Medicine, Boston

Pioneering epigenome editing company Tune Therapeutics has announced it is working on a new and potentially curative approach to treating chronic HBV infection.

Key Points: 
  • Pioneering epigenome editing company Tune Therapeutics has announced it is working on a new and potentially curative approach to treating chronic HBV infection.
  • (Graphic: Business Wire)
    The Tune HBV program was unveiled by Dr. Ed Gane, Professor of Medicine at the University of Auckland and world-renowned authority on Hepatitis B Virus (HBV) at the American Association for the Study of Liver Diseases ( AASLD ) conference in Boston, MA on November 11th.
  • As Tune Therapeutics’ Chief Scientific Officer Derek Jantz elucidates, this fact was the crucial driver for a new therapeutic approach using TEMPO.
  • “We can leverage the same, exact mechanism of virus control that we observe in these functionally-cured patients by switching off the virus using a targeted epigenetic silencer.

Arcus Biosciences Announces New Employment Inducement Grants

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Monday, November 13, 2023
Biotechnology, Other Professional Services, Health, Business, Other Health, Pharmaceutical, Professional Services, Oncology, Other Science, Research, General Health, Genetics, Science, Clinical Trials, NYSE, NYSE Listed Company Manual, Compensated emancipation, Cancer, Pharmaceutical industry

Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced that the Compensation Committee of the Company’s Board of Directors granted 12 new employees options to purchase a total of 31,200 shares of the Company’s common stock at an exercise price per share of $16.01, which was the closing price on November 8, 2023, and restricted stock units to acquire a total of 15,600 shares of the Company’s common stock.

Key Points: 
  • Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced that the Compensation Committee of the Company’s Board of Directors granted 12 new employees options to purchase a total of 31,200 shares of the Company’s common stock at an exercise price per share of $16.01, which was the closing price on November 8, 2023, and restricted stock units to acquire a total of 15,600 shares of the Company’s common stock.
  • The equity awards were granted pursuant to the Company’s 2020 Inducement Plan, which was approved by the Company’s Board of Directors in January 2020 pursuant to the “inducement exception” under NYSE Listed Company Manual Rule 303A.08.

Antibe Reports Q2 2024 Interim Financial and Operating Results

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Monday, November 13, 2023
Biotechnology, Health, Clinical Trials, Safety, IP, OTCQX, Bank statement, Hydrogen sulfide, Administration, Research, Phase II, SEDAR, Hand, MD, Development, Phase, Family, State Administrative Expenses, Antibe Therapeutics, TSX, Inflammation, Patent, Pharmaceutical industry

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to develop next-generation therapies to target inflammation, has filed its financial and operating results for the fiscal quarter ended September 30, 2023.

Key Points: 
  • Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to develop next-generation therapies to target inflammation, has filed its financial and operating results for the fiscal quarter ended September 30, 2023.
  • While trial initiation remains set for calendar Q1 2024, the Company now anticipates top-line results in calendar Q3 2024.
  • General and Administrative Expenses: General and administrative expenses were $1.9 million, compared to $1.7 million in fiscal Q2 2023.
  • The Company’s unaudited fiscal Q2 2024 condensed interim financial statements and MD&A are available on SEDAR.

DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2023 Financial Results

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Monday, November 13, 2023
Health, FDA, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, TPA, Food, NIHSS, Investment, Clinical trial, DSM-IV codes, Patient, Research, AIS, DMAC, G&A, Stroke, Patent, Trial of the century, PPD, R, Hospital, ChromeOS, MRS, KLK1, Pharmaceutical industry, Cryptocurrency

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the quarter ended September 30, 2023.

Key Points: 
  • DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today provided a business update and financial results for the quarter ended September 30, 2023.
  • Management will host a conference call Tuesday, November 14, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and third quarter 2023 financial results.
  • These study modifications include focusing participant eligibility to those subjects with only moderate acute ischemic strokes in the anterior circulation.
  • DiaMedica Management will host a conference call and webcast to discuss its business update and third quarter 2023 financial results on Tuesday, November 14, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time:

Alpine Immune Sciences Presents New Translational Data on Acazicolcept in Systemic Lupus Erythematosus at American College of Rheumatology Convergence 2023

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Monday, November 13, 2023
Biotechnology, Genetics, Health, Clinical Trials, Gene, Rheumatology, Patient, Inflammation, Synergy, Lupus, American College, CD28, SLE, ALPN, CD80, Alpine, ICOS, Autoimmunity, Immunoglobulin G, CD86, Pharmaceutical industry, Vaccine, Research

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced today that the Company presented new translational data for acazicolcept (ALPN-101) in systemic lupus erythematosus (SLE) at the American College of Rheumatology Convergence 2023, November 10-15, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced today that the Company presented new translational data for acazicolcept (ALPN-101) in systemic lupus erythematosus (SLE) at the American College of Rheumatology Convergence 2023, November 10-15, 2023.
  • Acazicolcept target-related genes (ICOS, CD80, CD86) are upregulated in the T and B cells of SLE patients compared to healthy adults.
  • Acazicolcept reduces pathogenic hypergammaglobulinemia and glomerular IgG deposition in a mouse model of lupus.
  • Clinical investigation of acazicolcept for the treatment of SLE, such as in our ongoing phase 2 study, Synergy, continues to be supported.”

Anthos Therapeutics' Novel Dual-Acting Factor XI/XIa Inhibitor, Abelacimab 150 mg, Demonstrated a 67% Reduction in the Primary Endpoint of Major or Clinically Relevant Non-Major Bleeding Compared with Rivaroxaban in Patients with Atrial Fibrillation

Retrieved on: 
Sunday, November 12, 2023
Biotechnology, Surgery, Health, Pharmaceutical, Clinical Trials, Ruff, Harvard University, Atrial fibrillation, Arrhythmia, Associate, Safety, Therapy, MIT, Factor XI, Risk, AHA, Multimedia, Anticoagulant, Stroke, Heart failure, American Heart Association, Thrombosis, DOAC, Hemostasis, Bleeding, Harvard Medical School, MPH, CDC, Hospital, Ventricular fibrillation, Pharmaceutical industry, Rivaroxaban, Medicine, MD, Brigham, Patient

Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.

Key Points: 
  • Anthos Therapeutics has initiated an extension study to enable patients to transition from rivaroxaban to abelacimab to benefit from the improved bleeding profile.
  • Although currently available anticoagulants are effective in preventing strokes in patients with atrial fibrillation, the risk of bleeding remains an issue.
  • “Based on the evidence to date, we are highly confident that abelacimab will offer a potential game-changing treatment approach for patients with atrial fibrillation."
  • Abelacimab is an investigational agent and is not approved for any indication in any country.

Ajinomoto Co., Inc. to Acquire Forge Biologics for $620 Million1

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Monday, November 13, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Acquisition, TYO, CDMO, Patient, Ice, ASV, CGMP, Growth, Health care, Corporate title, Ajinomoto, Pharmaceutical industry, Forge

Ajinomoto Co., Inc. ("Ajinomoto Co."; TYO: 2802) and Forge Biologics (Forge), announced today that they have entered into a definitive agreement by which Ajinomoto Co., will acquire Forge, a leading manufacturer of genetic medicines, in an all-cash deal for $620 million1.

Key Points: 
  • Ajinomoto Co., Inc. ("Ajinomoto Co."; TYO: 2802) and Forge Biologics (Forge), announced today that they have entered into a definitive agreement by which Ajinomoto Co., will acquire Forge, a leading manufacturer of genetic medicines, in an all-cash deal for $620 million1.
  • All development and manufacturing is done at the Hearth, Forge’s 200,000 square foot custom-designed cGMP facility in Columbus, Ohio, where the business has over 300 employees.
  • “Our teams share a commitment to investing in innovation that helps our clients succeed in delivering therapies to patients in need.
  • Upon completion, Forge will become a fully consolidated subsidiary of Ajinomoto Co., Inc. Centerview Partners LLC served as lead financial advisor and Ice Miller LLP served as legal advisor to Forge in the transaction.