AXS-12 for Narcolepsy - Phase 3 Results

Axsome Therapeutics released phase 3 results with AXS-12 for patients with Narcolepsy type 1 (NT1). The primary endpoint of the study was to determine if AXS-12 (reboxetine) reduced Cataplexy attacks, after five weeks of dosing. The results were significant, in addition to an earlier phase 2 study.

• 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 two clinical trials, and prior clinical and non-clinical studies, Axsome plans to submit an NDA (new drug application) with approval for patients with Narcolepsy experiencing Cataplexy attacks. The gating factor will be the long-term safety data, that is still ongoing with an expected completion date by December 2024. 

Weekly chart of Axsome below. Thank you for reading.

Bitcoin and Gold All-Time Highs

Bitcoin and Gold have reached new all-time highs. What is the reason? There was an interesting research note by Bank of America strategist Michael Hartnett that may explain, regarding the current US debt. The summary of their research suggests, that one trillion in new debt inflation is occurring every 100 days, reaching 34 trillion in national debt currently. Alternative assets such as bitcoin and gold, have become attractive for investors seeking non inflationary assets. 

Bitcoin's supply limit known as the hard cap is set at 21 million, which is designed to create scarcity and and prevent inflation. The 21 million is the maximum number of bitcoin that can ever be created. Gold has historically acted as a source of value, during economic uncertainty and inflation. Below are charts of bitcoin, gold and US debt. Thank you for reading. 

Bitcoin Moves Higher

Bitcoin has put in a nice move higher this week. I'm inserting an article from Crypto Presales, Nigeria Blocks Access to Crypto Exchanges. The main driver of the article relates to currency, as citizens try to move money out of a sliding currency, in this case the Naira, and into crypto, such as bitcoin, seeking less inflation. The government intends to block the on-line exchange of companies like Binance, Coinbase, and Kraken. Weekly chart below of Bitcoin, below. 

Axsome Fourth Quarter Financial Results

Axsome released their fourth quarter financial results today. Just a few highlights from the just completed impressive quarter, are below. 

• Auvelity for MDD sales totaled $49.0 million for the quarter
• Sunosi for narcolepsy sales totaled $22.5 million for the quarter
• $386 million in cash on hand, end of quarter
• AXS-12 clinical trial for cataplexy, to read out in the first quarter, 2024
• AXS-05 clinical trial for Alzheimer's Disease Agitation, second half 2024

The only negative seen for this quarterly release is the clinical trial of AXS-05 for Alzheimer's Disease Agitation, which has been moved to be released in the second half of 2024.  Current chart of Axsome below. Thank you for reading.

Alzheimer's Disease Agitation

Alzheimer's Disease Agitation, is an unmet medical need. Three companies have addressed potential therapy for these patients.  Otsuka and partner Lundbeck with Brexpiprazole, has already achieved FDA approval as the first and only approved drug, but carries a Black Boxed Warning. Another candidate from Otsuka again, is AVP-786. AVP-786 has yet to achieve two meaningful positive clinical trial readouts, and has two clinical trials scheduled to complete in 2026. Axsome's AXS-05 has completed one successful clinical trial known as ADVANCE-1. AVANCE-2 is scheduled to read out in the first half of 2024. If successful, the company will pursue an sNDA filing with the FDA for approval.  Click on chart below for a larger version. Thank you for reading.