Avenue Therapeutics Inc (ATXI) News & EventsATXINews & EventsAvenue Therapeutics Inc

Avenue Therapeutics Enters Exclusive License Agreement with Duke University for ATX-04

Avenue Therapeutics announced that it has entered into an exclusive worldwide license agreement with Duke University for patents and know-how pertaining to ATX-04 in clinical development for the treatment of Pompe disease. "ATX-04 represents an asset with a favorable risk profile, supported by compelling human clinical data generated at Duke demonstrating functional, biochemical, and molecular benefit in Pompe disease," said Alexandra MacLean, M.D., Chief Executive Officer of Avenue Therapeutics. "This license allows us to advance a differentiated, mechanism-based therapy with the potential to meaningfully enhance outcomes for patients receiving standard-of-care ERT."

Avenue Therapeutics reveals Axsome's acquisition of Baergic Bio

Avenue Therapeutics (ATXI) subsidiary, Baergic Bio announced that Avenue has entered into an agreement for Baergic to be acquired by Axsome Therapeutics (AXSM), including the global rights to BAER-101, a novel oral GABAA alpha subtype-selective receptor positive allosteric modulator. BAER-101 was originally licensed by Baergic from AstraZeneca (AZN) and will be referred to as AXS-17 by Axsome going forward. Axsome intends to evaluate AXS-17 as a potential treatment for epilepsy. Axsome will receive worldwide commercial, development, and manufacturing rights to BAER-101, including all available nonclinical and clinical data. The transaction was effectuated through Axsome's acquisition of 100% of the equity interests in Baergic, a subsidiary of Avenue, and concurrent amendment to the License Agreement between Baergic and AstraZeneca. Under the terms of the purchase agreement, Baergic Bio shareholders will receive a $0.3 million upfront payment (less transaction expenses) and are eligible to receive milestone payments of up to $2.5 million upon the occurrence of certain development and regulatory events 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 AXS-17. Avenue expects to receive ~74% of all future payments and royalties payable under the agreement.

Axsome Secures Exclusive Global Rights to AZD7325 Through New Agreement

Axsome Therapeutics (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.