In a recent development, the U.S. Food and Drug Administration (FDA) has declined to approve Shin Nippon Biomedical Laboratories’ treatment for acute migraine, citing manufacturing concerns. The decision had an immediate impact on the Japan-listed stock of Shin Nippon (SNBL), which witnessed a 12.2% decline, closing at 1,721 yen ($11.64) on Thursday.
Shin Nippon Biomedical Laboratories had acquired the drug through its purchase of Satsuma Pharmaceuticals in April the previous year. Despite the FDA’s complete response letter, SNBL clarified that there were no concerns related to the data, and no additional information was requested. The drug had previously shown disappointing results in a late-stage study in November 2022, failing to meet key goals when compared to a placebo.
While the FDA’s decision delays Shin Nippon’s entry into the competitive U.S. market for migraine drugs, the company remains optimistic. SNBL plans to collaborate with the FDA for the re-submission of the marketing application for the drug, as stated by Dr. Ryoichi Nagata, CEO of Satsuma. Analysts, such as Stephen Barker from Jefferies, note that SNBL’s ownership of Satsuma could be considered a distraction from its primary pre-clinical testing business, but the company is likely to invest time and resources to address FDA concerns due to the potential of Satsuma’s pipeline.
The treatment developed by Shin Nippon involves delivering a powdered form of dihydroergotamine through a nasal spray. Migraine, affecting millions of Americans and a significant global population, represents a lucrative market for new migraine drugs. Despite the setback, Shin Nippon Biomedical Laboratories is determined to navigate through the regulatory challenges and pursue FDA approval for its migraine treatment.