Market Launch DelaysA more conservative estimate for the US/Europe launch timeline has been assumed, pushing it from 2028 to 2029.
Recruitment IssuesRecruitment for the proof-of-concept trial for GH001 for bipolar depression in Type 2 bipolar disorder remains slow, leading to an end of the trial soon.
Regulatory ChallengesThe company is working towards getting the FDA's clinical hold removed on its investigational new drug application for GH001 in a proprietary inhalation device, indicating regulatory challenges.