Protagenic Therapeutics received written responses from the FDA regarding its Type B pre-IND meeting request for PT00114, an investigational neuropeptide candidate for generalized anxiety disorder. The FDA raised no objections to the planned Phase 1 program design, dose-escalation approach, or chemistry, manufacturing, and controls packages. Consequently, the company intends to submit a new Investigational New Drug application before the end of 2026, with first patient dosing targeted for the first half of 2027. Protagenic Therapeutics is a clinical-stage biopharmaceutical company developing peptide-based treatments for stress-related neuropsychiatric disorders.