Friday, November 29, 2024

AXS-12 Long-Term Phase 3 Study

Axsome Therapeutics completed their phase 3 12 month long-term study with Narcolypsy drug candidate AXS-12. The results confirmed the prior phase 2 and phase 3 studies completed. 

  • Phase 3 long-term reduced cataplexy attacks vs. placebo (p=0.017)
  • Phase 3 significantly reduced cataplexy attacks vs. placebo (p=0.018)
  • Phase 2 significantly reduced cataplexy attacks vs. placebo (p=0.001)

Based on these results, Axsome will file a new drug application (NDA) with AXS-12 for Narcolypsy patients experiencing cataplexy first half of 2025, and if approved will be on the market in 2026. AXS-12 has patent to 2039. This will be a smaller revenue producer compared to what Auvelity revenues will be producing for MDD, but still significant for a small but growing biotech company. Chart of Axsome below show's stock hovering around $100 per share. Thank you for reading.



Tuesday, November 12, 2024

Axsome Third Quarter Financial Results

Today, Axsome Therapeutics announced third quarter financial results. The results were positive as noted below.

  • Total revenue was $104 million, their first quarter over $100 million
  • Revenue exceeded analyst estimates, which were expecting $98 million
  • Alzheimer's data to be released as previously guided in this 4th quarter
  • Alzheimer's data for the two trials will be released simultaneously
  • ADHD data to be released in the first quarter of 2025
  • $325 million of cash on hand, end of the third quarter
The important information learned, is that the Alzheimer's clinical trial results will be released prior to years end 2024. Chart of Axsome below, as the stock had a strong day, and closed at $99.49 per share.