Part 6/10:
In contrast to the optimistic discussion around Takeda and Shire, the episode also highlighted Alchemy’s recent challenges concerning its drug application for ACLX-5461, an antidepressant medication. The U.S. FDA issued a "refused to file" letter, indicating that Alchemy's submission lacked adequate information for evaluation. This development poses serious implications for Alchemy, as it had hinged its expectations on a successful review from the FDA.