The pressure to replace animal testing with human-relevant assays that are more predictive of human-drug responses has now reached a tipping point, and there is a movement toward greater acceptance of these potentially more translatable tests.
Viking Therapeutics Inc. said after-market hours Feb. 11 that it plans to advance its oral dual GLP-1/GIP receptor, VK-2735, into a phase III trial for obesity in the third quarter of 2026. VK-2735 is a novel dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist.
Citing an increase in safety events and evidence of futility, the U.S. NIH stopped an investigational low-dose rivaroxaban arm of its Comparison of Anticoagulation and Antiplatelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49, having traded as low as $36.66 as investors learned of the RTF letter, which Moderna said is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-BLA-submission talks.
Precision Biosciences Inc. has received FDA clearance of its IND application enabling clinical trial site activation for a phase I/II trial (FUNCTION-DMD) of PBGENE-DMD for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD). The first site in the U.S. will be activated in the first half of this year.
The SEC filed civil charges against CBA Pharma Inc. and two top executives in U.S. district court, alleging they conducted a fraudulent securities offering that raised about $4.1 million from nearly 160 investors.
Novo Nordisk A/S’ television ad introducing the tablet form of its weight-loss drug, Wegovy (semaglutide), to American consumers didn’t pass regulatory muster.
As many had predicted following news of a clinical hold on the gene therapy last month, Regenxbio Inc. disclosed receipt of a complete response letter (CRL) regarding its BLA for RGX-121 (clemidsogene lanparvovec) in mucopolysaccharidosis II, an ultrarare neurodegenerative disease in dire need of new therapies.
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