Axsome Therapeutics Acquires Subtype Selective GABA-A Receptor Positive Allosteric Modulator AZD7325 for the Treatment of Epilepsy

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Axsome obtains exclusive global rights to AZD7325, a novel oral selective GABA_A α2,3 receptor positive allosteric modulator

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Deepens Axsome’s broad and innovative neuroscience portfolio with a synergistic early-stage program for epilepsy

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NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into an agreement to obtain exclusive global rights to AZD7325, a novel oral GABA_A receptor α2,3 subtype-selective positive allosteric modulator (PAM), licensed from AstraZeneca AB (NASDAQ: 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.

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“This transaction adds AZD7325, an earlier stage molecule with a differentiated mechanism of action, to our leading late-stage CNS portfolio,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We are excited to further deepen our research pipeline in a complementary way, and to extend our clinical efforts into epilepsy, an area where there is an urgent need for innovative new treatment options for patients.”

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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.

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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, Inc. (OTC: 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.

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About Epilepsy

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Epilepsy is a chronic and debilitating neurological disorder that affects approximately 3.4 million people in the U.S., with about 150,000 new cases diagnosed each year.^1-3 It is characterized by recurrent, unprovoked seizures, or sudden and uncontrolled surges of electrical activity in the brain that can cause involuntary movements, sensory disturbances, loss of awareness, or convulsions.^3,4 People living with epilepsy often face stigma, barriers to education and employment, higher rates of comorbid psychiatric conditions, and increased risk of premature mortality, contributing to reduced quality of life and social isolation.^5-7 Despite currently available treatment options, more than one-third of patients do not respond to treatment.⁸

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About Axsome Therapeutics

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Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.