Pharmaceutical

ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

11/08/2024

Efficacy signals observed will not achieve ESSA’s target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination…

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Skye Bioscience Demonstrates Prominent Role of Peripheral CB1 Inhibition and Achieves Significant Weight Loss with Novel CB1-inhibiting Antibody, Nimacimab, in Preclinical Model

11/06/2024

Peripherally-restricted nimacimab achieves significant dose-dependent weight loss, fat mass reduction, lean mass preservation, and glycemic control in diet-induced obesity model Preliminary data shows that nimacimab achieves desired metabolic outcomes without central inhibition and its risk of neuropsychiatric adverse events Excerpt from the Press Release: SAN DIEGO, Nov. 04, 2024 (GLOBE NEWSWIRE) — Skye Bioscience, Inc.…

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Maze Therapeutics Reports Positive First-in-Human Data from Phase 1 Healthy Volunteer Clinical Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease (AKD)

11/05/2024

MZE829 Well-tolerated with Dose-proportional Pharmacokinetics Supporting Once Daily Dosing Data Support Advancement of MZE829 into Planned Phase 2 Clinical Trial in Patients with AKD Data Presented Today at the American Society of Nephrology Kidney Week 2024 Excerpt from the Press Release: SOUTH SAN FRANCISCO, CA., October 25, 2024 – Maze Therapeutics, a clinical-stage biopharmaceutical company…

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Evoke Pharma & EVERSANA Announce Statistically Significant Improvement in Patient Outcomes for GLP-1 users with Diabetic Gastroparesis using GIMOTI®

11/04/2024

Analysis of real-world data compared patients on GIMOTI (n=51) to Oral Metoclopramide (n=41), both taking GLP-1s, showing significant statistical improvement for GIMOTI over Oral Metoclopramide in All Cause Emergency Department Visits (-91%, p=0.001), All Cause Office Visits (-41%, p=0.027) and All Cause Hospital Outpatient Visits (-89%, p=0.032) within 6-month index period Data presented at American…

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Sun Pharma Presents New Clinical Efficacy and Safety Data in Severe Dermatological Conditions at the 2024 European Academy of Dermatology and Venereology (EADV) Congress

10/03/2024

New data demonstrate improved hair satisfaction in more than 95% of patients taking deuruxolitinib and clinically meaningful improvements in depression and anxiety from baseline to Week 24 Studies also confirm dose optimization, with results demonstrating greater response with 8 mg tablets twice-daily as compared to higher once-daily dosing Excerpt from the Press Release: MUMBAI, India…

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Oruka Therapeutics Announces Accelerated Clinical Timelines and Upcoming Presentation at EADV Supporting ORKA-001’s Profile as a Potentially Best-in-Class Half-Life Extended Antibody Targeting IL-23p19

09/27/2024

ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody (mAb), first-in-human dosing now expected first quarter 2025 ORKA-002, a novel half-life extended IL-17A/F mAb, first-in-human dosing now expected third quarter 2025 New preclinical data on ORKA-001 to be presented at EADV in September showing robust preclinical activity including a half-life in NHPs of over 30 days…

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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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Evommune Announces Positive Proof-of-Concept Clinical Trial Results for its MRGPRX2 Antagonist (EVO756)

08/01/2024

Excerpt from the Press Release: PALO ALTO, Calf., July 16, 2024 /PRNewswire/ — Evommune, Inc., a clinical stage biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced positive results of its first-in-human proof-of-concept study with EVO756. By blocking MRGPRX2 activation and degranulation of mast cells, EVO756 has the potential to…

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Allogene Therapeutics Activates Three Community Cancer Centers as First Sites for the Pivotal Phase 2 ALPHA3 Trial Evaluating Cemacabtagene Ansegedleucel (cema-cel) as First Line (1L) Consolidation Treatment for Patients with Large B-Cell Lymphoma (LBCL)

07/11/2024

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., July 01, 2024 (GLOBE NEWSWIRE) — Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that Rocky Mountain Cancer Centers (RMCC), part of the US Oncology Network and Sarah…

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Eirion Therapeutics Announces Initiation of First-in-Human Clinical Trial Evaluating Topical ET-02 for the Treatment of Androgenic Alopecia

07/10/2024

Excerpt from the Press Release: WOBURN, Mass., July 1, 2024 /PRNewswire/ — Eirion Therapeutics Inc. announced today that the first participant has been enrolled in a Phase 1 clinical trial to evaluate the safety of the patented topical pharmaceutical ET-02 for the treatment of androgenic alopecia (age-related hair loss). This double-blind, placebo-controlled study is designed…

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