Astrazeneca plc reported results from its BaxHTN phase III trial showing aldosterone synthase inhibitor (ASI) baxdrostat met primary and secondary endpoints in patients with uncontrolled or treatment-resistant hypertension. The news marks a positive outcome of the company’s $1.8 billion gamble on Cincor Pharma Inc. in 2023, and keeps baxdrostat in the race with Mineralys Therapeutics Inc., which has said it anticipates a pre-NDA meeting this year for its ASI, lorundrostat, after reporting pivotal hypertension data in March 2025.
Manufacturing issues are the latest problem for Ultragenyx Pharmaceutical Inc. to solve after last week’s disappointment in a phase III study to treat brittle bones. The U.S. FDA gave the company a complete response letter (CRL) regarding the BLA for its gene therapy to treat Sanfilippo syndrome type A, saying it needs more details and improvements made about CMC after having finished manufacturing facility inspections.
China’s National Medical Products Administration approved Ascentage Pharma Group Corp. Ltd.’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors.
“Loss of synapses and dysfunctional synapses in a region-specific way is important in Alzheimer’s. It’s actually the strongest correlate of cognitive decline, far more so than plaques and tangles, which are the pathological hallmarks,” Soyon Hong told the audience at the XVII Meeting on Glial Cells in Health and Disease, which was held in Marseille last week.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcus, Ascentage, Beigene, Klotho, Merck, Moderna, Taiho, Transcend.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Beone, Biocytogen, Eolas, Secarna, Vect-Horus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astellas, Mereo, Osivax, PDS, Pfizer, Tonix, Ultragenyx.
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