It looks like Biogen Inc.’s Nrf2 activator, Skyclarys (omaveloxolone), will maintain its status as the sole therapy approved for treating patients with Friedreich’s ataxia (FA), at least for now. The U.S. FDA asked for another “adequate and well-controlled study” in the complete response letter (CRL) issued to PTC Therapeutics Inc. for 15-lipoxygenase inhibitor vatiquinone. The agency said “substantial evidence of efficacy was not demonstrated.”
Rates of adverse events (AEs) gave pause to some on Wall Street, and shares of Viking Therapeutics Inc. (NASDAQ:VKTX) fell 42%, or $17.73, to close Aug. 19 at $24.36 after the firm reported 13-week data from the phase II trial with the oral tablet form of VK-2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Invyvid, Neurizon, Omeros, Precigen.
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