Month: September 2024

Rigel Announces First Patient Enrolled in Phase 1b/2 Triplet Therapy Trial of REZLIDHIA® (olutasidenib) in mIDH1 AML

09/16/2024

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Sept. 5, 2024 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first patient has been enrolled in a Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with REZLIDHIA® (olutasidenib) in patients…

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Schedule your personalized live demo with Christopher Kata and the TrialStat team during “SCDM” Sept 29 – Oct 2 2024

09/13/2024

Christopher Kata and the TrialStat team are exhibiting at this years SCDM meeting on Sept. 29 – Oct. 2, 2024 in booth #100. If you’re attending be sure to to reach out to Christopher to schedule a one on meeting or just drop by booth #100 at your convenience! We’re looking forward to providing live,…

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Relay Therapeutics Announces Positive Interim Data for RLY-2608 Demonstrating Clinically Meaningful Progression Free Survival

09/13/2024

9.2-month median PFS in heavily pre-treated patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D 33% ORR across all patients & 53% ORR in patients with kinase mutations at RP2D Favorable overall tolerability profile; at RP2D, only 2 patients discontinued treatment due to adverse events & only 1 patient experienced Grade 3 hyperglycemia Data support…

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Tempo Therapeutics Announces First Patient Dosed in Clinical Trial of TT101 For Tissue Repair in Skin Cancer Surgery

09/12/2024

First Application of MAP technology in humans to drive regenerative biologic response and spare scarring Excerpt from the Press Release: SAN DIEGO, Sept. 5, 2024 /PRNewswire/ — Tempo Therapeutics, Inc. (“Tempo”), a leading innovator in tissue engineering and regenerative medicine, today announced the dosing of the first patients in a clinical trial of TT101 (the…

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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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