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.

 

Axsome Therapeutics - Development Pipeline

Knowing a companies pipeline of drug candidates, might give us a view of future products of commercialization, should everything work out favorable in clinical trials. With the 4th quarter of 2023 almost completed, a check on the pipeline of Axsome Therapeutics heading into 2024, is below.

                                                                

The important readout will the AXS-05 phase 3, Alzheimer's Agitation clinical trial, to be completed in the first half of 2024. Another notable readout, will be the Solriamfetol phase 3 for Attention Deficit Hyperactivity Disorder (ADHD), scheduled in the second half of 2024. Thank you for reading.

Ethereum Chart Update

Ethereum, the second largest cryptocurrency behind Bitcoin, is having a solid year to the upside, thus far, up around 65%. The weekly chart looks bullish on an intermediate basis, (weeks to months) with higher lows occurring, prior to the previous low. The current move higher has been strong, but met with an older resistance point, around the 2120 level, where ETH pulled back from there back in May.  A breakout above that 2120 resistance level, could take it higher 18% to my target point of 2500, per weekly chart below. Thank you for reading. 

Axsome 3rd Quarter Financial Results

Axsome released their third quarter financial results on Monday. Just a few highlights from the just completed impressive quarter, are below. 

• Auvelity for MDD sales totaled $37.7 million for the quarter
• Sunosi for narcolepsy sales totaled $20.1 million for the quarter
• $417 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, complete first half of 2024

Below is up to date, weekly prescriptions of Auvelity for MDD. Thank you for reading.

      

2023 Asset Performance - 3rd Quarter

With the 3rd quarter of 2023 just completed, a quick check on the performance of what different assets, have returned to date. What's notable is the sharp fall of bonds going negative, as interest rates have surged. Interest rates and the price of bonds have a negative correlation.  Cryptocurrency, including bitcoin and ethereum, along with stocks are still in the green end of third quarter. Chart below, thank you for reading.

  

Auvelity Prescription Update

Auvelity weekly prescription data continues to rise, at a nice measured pace. In the current third quarter of the  launch, the company has achieved over 5,000 weekly prescriptions. Prescription data provided by Bloomberg.   

Ethereum - Price Movement

Ethereum is a volatile cryptocurrency asset. Just like other assets have their correlations, or non-correlations for price movement, the same goes with Ethereum. The ten year treasury yield has been spiking along with interest rate increase. Ethereum has a high non-correlation, with the ten year bond yield, symbol $TNX. Because higher interest rates, mean higher borrowing costs, people could potentially start spending less, investing and speculating less. The chart below shows this non-correlation, in other words, as interest rates rise on the ten year yield, ETH goes down in price. A -1.00 is a perfect non-correlation and a 1.00 is perfect correlation. Currently the correlation is a -68. Chart below, has ETH in white and the ten year in red. Thank you for reading.

Axsome 2nd Quarter 2023 Financial Results

Axsome released their second quarter financial results on Monday August 7th. Just a few highlights from the just completed impressive quarter, are below. 

• Auvelity for MDD sales totaled $27.6 million for the quarter
• Sunosi for narcolepsy sales totaled $19.1 million for the quarter
• $468 million in cash on hand, end of quarter
• AXS-12 clinical trial for cataplexy, to read out in the fourth quarter, 2023
• AXS-05 clinical trial for Alzheimer's Disease Agitation, complete first half of 2024

Below are weekly prescriptions of Auvelity for MDD. Thank you for reading.