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MM120 Clinical Development & Regulatory - MM120 is undergoing a robust Phase 3 development program targeting a broad label for Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD)[40] - The Phase 3 program includes studies MM120-300, MM120-301 for GAD and MM120-310 for MDD, with primary endpoints of HAM-A at Week 12 and MADRS at Week 6 respectively[41] - MM120 has received breakthrough therapy designation from the U S FDA, supporting its potential for significant improvement over existing therapies[13, 58] - The company expects its cash, cash equivalents and investments of $245.5 million as of March 31, 2025, to fund operations into 2027[13] MM120 Efficacy & Safety - MM120 Phase 2b trial demonstrated a maximum effect size of d=0.81, more than double the standard of care for GAD[44] - In the Phase 2b trial, 48% of participants experienced remission at Week 12 in the 100 µg dose group[44] - The Phase 2b trial showed statistically significant improvements in HAM-A scores, with a -21.9 point change from baseline at Week 12 in the 100 µg dose group (p=0.003)[47] - The Phase 2b trial was well-tolerated, with 99% of adverse events being mild-to-moderate in severity and no drug-related serious adverse events[51] Market Opportunity & Commercial Strategy - Approximately 18% of U S adults reported living with anxiety symptoms in 2022, highlighting the significant unmet need in the GAD market[31] - 21.9 million U S adults experienced a major depressive episode (MDE) in 2023, indicating a substantial market for MDD treatments[35] - The company aims to integrate MM120 ODT delivery into the current interventional psychiatry infrastructure, leveraging existing networks of certified clinics and prescribers[61, 67]