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Sep 30, 2021
Axsome Q3 2021 Earnings Report
Reported third quarter results and provided business update.
Key Takeaways
Axsome Therapeutics reported financial results for the third quarter ended September 30, 2021. The company is advancing its late-stage CNS product candidates and preparing for potential commercial launches of AXS-05 and AXS-07, pending FDA approvals.
FDA review of NDA for AXS-05 in depression continues.
NDA for AXS-07 in migraine was accepted.
Phase 3 ACCORD trial of AXS-05 in Alzheimer’s disease agitation is ongoing.
Phase 3 SYMPHONY trial of AXS-12 in narcolepsy was initiated.
Axsome
Axsome
Forward Guidance
Axsome believes that its cash at September 30, 2021, along with the remaining committed capital from the $300 million term loan facility, is sufficient to fund anticipated operations into at least 2024. Axsome expects that its operating expenses will increase year over year as it continues to build out the commercial function and further advance its pipeline.
Positive Outlook
- AXS-05 for MDD, FDA action on NDA
- AXS-07 for migraine, FDA action on NDA (PDUFA date April 30, 2022)
- AXS-05 for MDD, commercial launch, if approved
- AXS-07 for acute migraine, commercial launch, if approved (2022)
- AXS-14 for fibromyalgia, NDA submission (2023)
Challenges Ahead
- Phase 3 SYMPHONY trial of AXS-12 in narcolepsy, topline data (1H 2023)
- Phase 3 ACCORD trial of AXS-05 for Alzheimer’s disease agitation, topline data (1H 2023)