Cervomed Inc. executives said they intend to scrutinize low plasma drug concentrations that appeared to spoil results from the phase IIb Rewind-LB trial testing neflamapimod in patients with dementia with Lewy bodies.
Four Chinese biopharmaceuticals unveiled early data on respective cancer therapies at the American Society of Hematology (ASH) 2024 meet in San Diego, including Cstone Pharmaceuticals Co. Ltd.’s receptor tyrosine kinase-like orphan receptor 1 (ROR1)-inhibiting antibody-drug conjugate (ADC) in phase I study for lymphomas.
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies compared to natural history external control are muscular enough to get the process going without having to dive into additional studies.
At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
Paradigm Biopharmaceuticals Ltd. raised AU$16 million (US$10.31 million) in a placement that will allow the company to start a global phase III trial with its lead product, Zilosul (injectable pentosan polysulfate/iPPS), to treat osteoarthritis.
Less than three months after going public via a $227.7 million IPO, shares of Bioage Labs Inc. (NASDAQ:BIOA) took a hit Dec. 9, losing 77% of their value, as safety concerns prompted the company to halt its phase II trial testing oral obesity candidate azelaprag. The Strides study, launched in July, had been testing azelaprag, an oral apelin receptor agonist licensed from Amgen Inc., as a monotherapy and in combination with GLP-1/GIP therapy Zepbound (tirzepatide, Eli Lilly and Co.) in obesity.
Agios Pharmaceuticals Inc. is learning the hard way the downside of having a pipeline in a product. When a side effect crops up, investors are likely to worry that it may affect the potential of the drug in the numerous diseases the drug could potentially treat.
Enanta Pharmaceuticals Inc. hit the mark that Wall Street hoped for, and details rolled out in top-line results from the first-in-pediatrics phase II study evaluating once-daily, oral zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).
New research confirmed long-term efficacy and safety of a novel minimally invasive procedure with Insightec Inc.’s Exablate transcanial magnetic resonance-guided focused ultrasound system to alleviate symptoms of severe obsessive-compulsive disorder.
Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35.
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