Monday, May 6, 2024

Axsome First Quarter Financial Results

Axsome Therapeutics released impressive first quarter results this morning. The biggest positive was that four Alzheimer's Agitation clinical trials are to be completed, which will lead to a NDA (new drug application) for that indication. Two clinical trials ADVANCE 1 and 2, have been designed as parallel assignment, and two clinical trials ACCORD 1, and 2, as randomized withdrawal trials. Both ADVANCE 1 and ACCORD 1 have successfully completed. ADVANCE 2 and ACCORD 2 are expected to complete this year. Upon completion, an NDA will be filed with the FDA for approval. Below are some positive points learned from the company's conference call this morning. 
  • Auvelity for MDD sales totaled $53.4 million for the quarter
  • Sunosi for narcolepsy sales totaled $21.6 million for the quarter
  • A second GPO (group purchasing organization) signed
  • 331 million in cash on hand, end of first quarter


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