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MindMed's MM120 Advances in Phase III Trials for GAD and MDD, Stock Surges

• MindMed's MM120, an orally disintegrating tablet form of LSD, is progressing through Phase III trials for generalized anxiety disorder (GAD) and major depressive disorder (MDD). • The company initiated the 52-week Voyage Phase III study for MM120 in GAD, with top-line data from a 12-week study expected in the first half of 2026. • A Phase III study of MM120 in major depressive disorder, named Emerge, is anticipated to start in the first half of 2025, with initial results expected in the second half of 2026. • MindMed's stock has risen significantly due to these advancements and positive Phase IIb data, along with Breakthrough Therapy Designation from the FDA for GAD.

MindMed is advancing its lead candidate, MM120, an orally disintegrating tablet (ODT) formulation of lysergide D-tartrate (LSD), into Phase III clinical trials for the treatment of generalized anxiety disorder (GAD) and major depressive disorder (MDD). The company's stock has seen a substantial increase, driven by these clinical advancements and promising early data.

Phase III Trials Underway for MM120

MindMed has initiated the 52-week Voyage Phase III study to evaluate MM120 ODT in patients with GAD. This trial follows positive Phase IIb data demonstrating efficacy exceeding current standard of care and a favorable tolerability profile. Top-line data from a 12-week segment of the Voyage study is expected in the first half of 2026. The FDA has granted Breakthrough Therapy Designation to MM120 for GAD, highlighting the urgent need for innovative treatments in this area, as the last new drug approval for GAD occurred in 2007.
A second Phase III study, Panorama, focusing on MM120 ODT in GAD, is slated to begin in the first half of 2025. Additionally, a Phase III trial of MM120 ODT for major depressive disorder, named Emerge, is also expected to commence in the first half of 2025, with initial data from the 12-week double-blinded portion (Part A) anticipated in the second half of 2026.

Unmet Needs in Anxiety and Depression

MindMed estimates that GAD and MDD affect approximately 51 million adults in the United States. These conditions represent a significant unmet medical need, with limited innovation in treatment options over the past 25 years. The company believes MM120 ODT offers a novel and differentiated approach for individuals suffering from GAD and MDD.

Financial Position and Analyst Outlook

MindMed has secured approximately $250 million through recent equity financings. The company also obtained a new patent covering MM120 ODT, extending intellectual property protection through 2041. Analysts have revised loss estimates for MindMed, reflecting increased optimism about the company's prospects. Specifically, 2024 loss estimates have improved from $1.60 per share to $1.57 per share, and 2025 loss estimates have improved from $1.36 per share to 67 cents per share in the past 60 days.
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Reference News

[1]
MindMed Stock Skyrockets 94% Year to Date: What's Driving It? - Yahoo Finance
finance.yahoo.com · Dec 25, 2024

MindMed is advancing MM120, an LSD-based treatment for GAD and MDD, with significant milestones in 2024 including a phas...

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