Solriamfetol for ADHD Phase 3 Results

Axsome released phase 3 clinical data from the (FOCUS) study with drug Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD), with results being statistically significant, rated under the AISRS (primary endpoint) versus placebo with 150mg dose.

FOCUS Phase 3 Results:

• AISRS compared to placebo p=0.039 
• CGI-S compared to placebo p=0.017

The company will next have to run a pediatric phase 3 study scheduled for 2025. If positive then can submit to the FDA a new drug application. The advantage over current treatments, is that Solriamfetol is considered a non-stimulant drug, and potential improvement from a safety profile from currently approved ADHD drugs on the market. Thank you for reading.

Axsome Fourth Quarter Financial Results

Axsome released 4th quarter financial results today, a couple of highlights from the quarterly and year end release. 

• ADHD phase 3 results, first quarter of 2025
• AXS-05 for Alz Agitation NDA to be submitted 2nd half 2025
• AXS-12 for Narcolepsy NDA to be submitted 2nd half 2025
• $315 million in cash, end of 2024

Good quarter, and great 2024 completed. The stock is at an all-time high level around $130.00 per share chart below. Thank you for reading. 

 

Axsome Second Quarter Financial Results

Axsome Therapeutics released impressive second quarter results this morning. The biggest positive was that ADVANCE 2 for Alzheimer's Agitation, is to be released second half of 2024. 

• Auvelity for MDD sales totaled $65 million for the quarter
• A New Drug Application for AXS-07 has been submitted
• Alzheimer's Agitation phase 3, to be released 2nd half 2024
• ADHD phase 3 clinical trial results, 2nd half 2024

The stock had a wild day due to overall market volatility, recording a low of 72.21 early, but closed at 83.21 end of day, outperforming the broader market sell-off. Thank you for reading.