Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
Pliant Therapeutics Inc., which offered few details earlier this week when it voluntarily paused enrollment in the phase IIb Beacon-IPF trial testing bexotegrast in idiopathic pulmonary fibrosis (IPF), has taken an unusual step as it assembles a panel of outside experts to review unblinded data from the study with the goal of providing an independent recommendation.
While first-generation glucagon-like peptide-1 receptor agonists have clearly taken the obesity market by storm, generating billions of dollars for Novo Nordisk A/S and Eli Lilly and Co., several other companies are developing follow-on products that could clean up the tolerability and adherence issues of Wegovy (semaglutide) and Zepbound (tirzepatide).
Biotronik Neuro’s Prospera spinal cord stimulation system achieved more than 50% pain reduction for 86% of patients with back pain and 89% of patients with leg pain over two years, according to new study results.
Kura Oncology Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, met the primary endpoints in the phase II registrational Komet-001 trial in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and Kura expects to submit its NDA to the U.S. FDA in the second quarter of 2025.
The closely watched chronic spontaneous urticaria (CSU, or hives) space chalked more early stage KIT inhibitor data as Third Harmonic Bio Inc. rolled out results from the phase I single and multiple ascending-dose trial with THB-335 in healthy volunteers, along with plans to move the oral candidate into phase II development by the middle of 2025.
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
4D Molecular Therapeutics Inc.’s gene therapy, 4D-150, in wet age-related macular degeneration (wet AMD) produced positive phase IIb data as the company preps two phase III studies set to begin this year.
A mysterious turn in the phase IIb story with idiopathic pulmonary fibrosis (IPF) candidate bexotegrast sent shares of Pliant Therapeutics Inc. (NASDAQ:PLRX) down 60.6%, or $4.72, to close Feb. 10 at $3.07.
A 1,000-person study using Heartflow Inc. technology demonstrated that findings of coronary plaque on heart CT scans could indicate which patients were at risk of cardiovascular events up to seven years in the future – potentially providing a road map toward screening for heart disease, the leading cause of death for both men and women in the U.S. and worldwide.
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