Lyndra Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for Lyndra’s Weekly Risperidone (LYN-005) for the Treatment of Adults with Schizophrenia and Other Indications
The company plans to initiate its pivotal program for LYN-005, designed as the first-ever oral, ultra-long-acting, extended-release therapy, in early 2022.
- The company plans to initiate its pivotal program for LYN-005, designed as the first-ever oral, ultra-long-acting, extended-release therapy, in early 2022.
- Both studies will evaluate LYN-005 at weekly doses ranging from 2 to 6 mg risperidone daily.
- These studies will support indications in schizophrenia, bipolar mania, and bipolar 1 disorder.
- We are grateful to the FDA for their guidance as we design this pivotal program.