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Ocugen Announces Completion of Dosing in Subjects with Stargardt Disease in High Dose Cohort of Phase 1/2 GARDian Clinical Trial of OCU410ST—A Modifier Gene Therapy

09/11/2024

Excerpt from the Press Release: MALVERN, Pa., Aug. 28, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 GARDian clinical trial for…

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Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1117568 in Adults with Schizophrenia

09/10/2024

Excerpt from the Press Release: SAN DIEGO, Aug. 28, 2024 /PRNewswire/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive top-line data for its Phase 2 clinical study of NBI-1117568 (NBI-‘568) in adults with schizophrenia. NBI-‘568 is the first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia. The NBI-‘568-SCZ2028 dose-finding…

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NextPoint Therapeutics Announces First-in-class T Cell Engager NPX372 As New Drug Candidate Targeting B7-H7 in Solid Tumors

09/09/2024

CD3 bispecific antibody developed to redirect T cell-mediated immunity toward B7-H7 expressing tumors, expanding monotherapy treatment possibility for a new patient population Company’s precision immunotherapy approach enables prospective identification of patients most likely to benefit from NPX372 with a defined clinical biomarker Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–NextPoint Therapeutics, a clinical-stage biotechnology company…

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Aethlon Medical Announces Publication of Preclinical Data Showing Ability of the Hemopurifier® to Remove Extracellular Vesicles and microRNAs from Renal Perfusates Following Controlled Oxygenated Rewarming of Discarded Donor Kidneys

09/09/2024

Results Support Future Study of the Hemopurifier® as Part of a Machine Perfusion Circuit to Further Assess its Association with Function of Retrieved Kidneys Excerpt from the Press Release: SAN DIEGO, Aug. 27, 2024 /PRNewswire/ — Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious…

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Life Molecular Imaging Receives FDA Fast Track Designation for [18F]PI-2620 in Tau PET Imaging Across Three Neurodegenerative Conditions

09/06/2024

Fast Track Designation Granted for use in patients being evaluated for Alzheimer’s Disease, Progressive Supranuclear Palsy, or Corticobasal Degeneration Excerpt from the Press Release: BOSTON, Aug. 28, 2024 /PRNewswire/ — Life Molecular Imaging (LMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to [18F]PI-2620 Injection, an investigational…

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Jupiter Endovascular Receives FDA Approval for U.S. Pivotal Study of Vertex Pulmonary Embolectomy System Using Endoportal Control

09/05/2024

Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Jupiter Endovascular, Inc., a medical technology startup developing a new class of endovascular procedures using Endoportal Control™ to bring the precision and control of direct surgical access to catheter-based interventions, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption application…

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Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG990, its Novel Half-Life Extended OX40L Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

09/04/2024

Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases Excerpt from the Press Release: SAN FRANCISCO and WALTHAM, Mass., Aug. 19,…

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Sonnet BioTherapeutics Enters into Clinical Collaboration Agreement to Commence Investigator-Initiated and Funded Phase 1/2a Study of SON-1210 in Combination with Chemotherapy for the Treatment of Pancreatic Cancer

09/03/2024

Preclinical data has demonstrated the potential of SON-1210, the first albumin-binding bifunctional IL-12/IL-15 fusion protein, for solid tumor immunotherapy An Innovative Immuno Oncology Consortium (“IIOC”) led by Oncology experts funded by the Sarcoma Oncology Center will conduct an investigator-initiated Phase 1/2a study of SON-1210 in pancreatic cancer, an indication with significant unmet medical need Company…

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Evofem Biosciences Addresses the Impact of GLP-1 Medications on Oral Contraceptive Absorption and Introduces Phexxi as a Non-Oral Solution

09/02/2024

Excerpt from the Press Release: SAN DIEGO, Aug. 20, 2024 /PRNewswire/ — As the popularity of GLP-1 receptor agonists continues to surge in the treatment of obesity and type 2 diabetes, Evofem Biosciences, Inc. (OTCQB: EVFM) is raising awareness of the potential impact these medications may have on the effectiveness of oral contraceptives. With an…

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Skye Bioscience Launches Phase 2 CBeyond Clinical Trial of its Differentiated CB1 Inhibitor, Nimacimab, in Patients with Obesity

08/30/2024

CBeyond™ will assess nimacimab’s ability to safely induce weight loss, and will also evaluate a combination of a GLP-1 receptor agonist plus nimacimab Excerpt from the Press Release: SAN DIEGO, Aug. 22, 2024 (GLOBE NEWSWIRE) — Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health,…

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