Clinical

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Alzheimer’s drug discovery foundation’s statement on FDA advisory committee’s endorsement of donanemab

NEW YORK, June 10, 2024. Today, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer’s disease. If approved, donanemab would become the second disease-modifying drug for Alzheimer’s to receive full approval, expanding the arsenal of available drugs needed to treat Alzheimer’s […]
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Brii Bio Presents New Data from Its Ongoing Phase 2 Chronic Hepatitis B Trials

DURHAM, N.C. and BEIJING, June 7, 2024. Brii Biosciences Limited (“Brii Bio,” “we,” or the “Company”), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, presented new data from two Phase 2 studies evaluating BRII-179 either as a combination therapy with BRII-835 (elebsiran) or as an add-on […]
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AbbVie Announces Positive Topline Results from Phase 2 Trial Evaluating Elahere for High Folate Receptor-Alpha Expressing Platinum-Sensitive Ovarian Cancer

NORTH CHICAGO, Ill., June 6, 2024. AbbVie announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%). […]
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Surrozen Initiates Dosing of First Patient in Phase 1b Clinical Trial of SZN-043 for Severe Alcohol-Associated Hepatitis

SOUTH SAN FRANSCISO, Calif., June 04, 2024. Surrozen, Inc. (“Surrozen” or the “Company”), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today announced that the first patient has been dosed in its Phase 1b clinical trial for SZN-043 in patients with severe alcohol-associated hepatitis. The Phase 1b […]
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Novartis Phase III Data Confirm Sustained Efficacy and Long-Term Safety of Oral Remibrutinib in Chronic Spontaneous Urticaria

Basel, May 31, 2024 – Novartis today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU)1. In the pivotal Phase III studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant symptom improvement early, which was sustained up to Week 52, […]
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Avirmax Biopharma Inc. Receives IND Approval for Phase I/IIa Trial to Treat Wet AMD including PCV

HAYWARD, Calif., May 30, 2024. Avirmax Biopharma, Inc., a leading innovator in genetic medicines, is pleased to announce that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I/IIa clinical trial for its gene therapy treatment targeting wet Age-related Macular Degeneration (AMD) including Polypoidal […]
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Neuren Phase 2 trial shows significant improvements in Pitt Hopkins syndrome

MELBOURNE, Australia, May 27, 2024. Neuren Pharmaceuticals (ASX: NEU) today announced top-line results from its Phase 2 clinical trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). Statistically significant improvement from baseline was observed by both clinicians and caregivers from treatment, across all 4 efficacy measures that were specifically designed to assess the core […]
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HI-Bio Announces Positive Results from Phase 2 Study of Felzartamab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients

SOUTH SAN FRANCISCO, Calif., May 25, 2024. Human Immunology Biosciences (HI-Bio), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced positive results from a Phase 2 investigator-sponsored clinical trial of felzartamab for late antibody-mediated rejection (AMR) in kidney transplant recipients. Felzartamab is an investigational monoclonal antibody designed to […]
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Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of Afuresertib PLUS LAE001 for the Treatment of Prostate Cancer

SHANGHAI and WARREN, N.J., May 23, 2024. Laekna, Inc., a science-driven, clinical-stage biotechnology company, announced that the company has received approval from the U.S. Food and Drugs Administration for the protocol of the phase III clinical trial of LAE002 (afuresertib, an AKT inhibitor) plus LAE001 (CYP17A1/CYP11B2 dual inhibitor) (“LAE201”)in patients with metastatic castration-resistant prostate cancer […]
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New Results From Rilzabrutinib Phase 2 Study Show Potential to be First Advanced Oral Treatment for Moderate-to-Severe Asthma

Paris, May 22, 2024. Encouraging results from a phase 2 study showed that treatment with oral rilzabrutinib at both high dose and low doses led to a numerical reduction in loss of asthma control (LOAC) events (the primary endpoint) and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma. These results were presented today […]
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