Axsome enters agreement to obtain exclusive global rights to AZD7325

Axsome Therapeutics (AXSM) (AZXM) entered into an agreement to obtain exclusive global rights to AZD7325, a novel oral GABAA receptor alpha subtype-selective positive allosteric modulator, licensed from AstraZeneca AB (AZN). AZD7325 has completed Phase 1 trials. Axsome intends to evaluate AZD7325 as a potential treatment for epilepsy and plans to begin Phase 2 trial-enabling activities in 2026. AZD7325 has demonstrated anti-convulsant effects in preclinical seizure models. In clinical studies in over 700 patients to date, AZD7325 has demonstrated a favorable safety and tolerability profile. Axsome will receive worldwide commercial, development, and manufacturing rights to AZD7325. The transaction was effectuated through Axsome’s acquisition of a 100% equity interest in Baergic Bio, Inc., a subsidiary of Avenue Therapeutics (ATXI), and concurrent amendment to the License Agreement between Baergic Bio and AstraZeneca. Under the terms of the Baergic Bio Share Purchase Agreement, Baergic Bio shareholders will receive a $0.3 million upfront payment and are eligible to receive development and regulatory milestone payments of $2.5 million for the first indication and $1.5 million for each indication thereafter, up to $79 million in potential sales-based milestones, and a tiered mid-to-high single-digit royalty on potential global net sales of AZD7325. Under the terms of the License Amendment, AstraZeneca will receive a cash upfront payment in the single digit millions and is eligible to receive development and regulatory milestone payments for each indication, sales-based milestones, and a tiered mid-to-high single-digit royalty on potential global net sales of AZD7325.