Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter—your go-to source for the latest breakthroughs in the life sciences industry! In this issue: Hengrui’s diabetes drug shows strong clinical success—even outperforming semaglutide, Bayer secures expanded approval for its heart failure treatment, and BD announces a $17.5B life sciences megadeal with Waters. Plus, a major Alzheimer’s collaboration and a gene therapy setback. Stay informed and inspired by the innovations shaping the future of life sciences.
Hengrui’s Diabetes Drug Outperforms Semaglutide
Hengrui Pharma’s investigational dual GLP-1/GIP receptor agonist, HRS9531, delivered positive Phase 3 results in Chinese patients with type 2 diabetes. Administered once weekly, the drug significantly reduced HbA1c and body weight compared to both placebo and Novo Nordisk’s semaglutide. In addition to strong efficacy, HRS9531 showed a favorable safety profile, with gastrointestinal side effects being the most common. The promising results position HRS9531 as a strong contender in China’s competitive incretin drug market.
Alzheimer’s Deal Targets the Brain Barrier
Acumen Pharmaceuticals has signed a $555 million biobucks deal with Japan’s JCR Pharmaceuticals to advance a next-gen Alzheimer’s therapy. The collaboration will fuse Acumen’s AβO-targeting antibody ACU193 with JCR’s J-Brain Cargo® platform, which helps biologics cross the blood-brain barrier. This marks Acumen’s first external partnership and could enhance the delivery and efficacy of ACU193, which is already in Phase 2. The companies aim to overcome one of neuroscience’s biggest hurdles—getting drugs into the brain effectively.
FDA Widens Use of Kerendia for Heart Failure
The U.S. FDA has approved Bayer’s Kerendia (finerenone) for an expanded indication in adults with chronic kidney disease associated with type 2 diabetes, who also have either preserved or reduced ejection fraction heart failure. Previously limited to patients with reduced ejection fraction, this label expansion allows broader use across the full heart failure spectrum. Kerendia works by blocking the mineralocorticoid receptor, reducing inflammation and fibrosis—key drivers of both heart and kidney damage.
BD to Spin Off Diagnostics in Waters Megadeal
BD (Becton, Dickinson and Company) will divest its Biosciences and Diagnostics units to Waters Corporation through a $17.5 billion Reverse Morris Trust transaction. The move will create a new, unnamed public company focused on life sciences tools. BD’s shift aligns with its strategic focus on core technologies and innovation, while Waters will expand its scientific instrumentation and precision lab tools portfolio. The deal is expected to close in the first half of 2025, pending regulatory approvals.
Ultragenyx Gene Therapy Hits FDA Roadblock
The FDA has rejected Ultragenyx’s BLA for UX111, a gene therapy for Sanfilippo syndrome (MPS IIIA), citing unresolved manufacturing and product quality concerns. The agency did not request new clinical trials, but the rejection delays access to a potentially life-changing therapy for a fatal pediatric neurodegenerative disorder. Ultragenyx plans to resubmit the application, though timelines remain unclear. The setback underscores ongoing regulatory hurdles for gene therapies targeting rare diseases.
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