Axsome's depression drug Auvelity was launched late 2022, after FDA approval. Weekly scripts are closing in on the 10,000 per week level, according to IQVIA tracking. The week ending 7/19/24 had total prescriptions of 9,700, which is impressive as the company has yet to promote the drug via TV ad. Tracking the weekly progress of prescriptions, may give us insight into the revenues being reported for each quarter. Below is a chart of weekly prescriptions in 2024. Click on graph for sharper view.
We recently wrote about the company, here. Relmada Therapeutics High Risk with Potential Reward in June. Relmada Therapeutics stock has moved higher under heavy trading volume. The company had mentioned, the Data Monitoring Committee (DMC), would take an interim look at Reliance II after 75-80% of patients have enrolled into the study. Assuming that is the reason for the upward move in the stock, could be good news for the ongoing clinical trial for drug REL-1017 for adjunctive treatment of MDD. We'll have to wait until their quarterly conference call in August to see if that is the case. Below is a chart of the stock that has moved higher by 49% under heavy volume to a high of 4.47, and has settled at 4.16.
While the company is in the final stages of their Alzheimer's Disease Agitation clinical trials, ADVANCE 2 and ACCORD 2, a reminder of the results of already completed ADVANCE 1 and ACCORD 1 below.
ADVANCE 1 Results:
ACCORD 1 Results:
Relmada Therapeutics (RLMD) is in phase 3 clinical trials testing REL-1017, for the adjunctive treatment of MDD. Adjunctive treatment is used in addition to primary treatment to help it work better. Relmada's clinical trials can be viewed here Relmada Clinical Trials. The most important event from an investment point of view, is the release of top line data, for clinical trial RELIANCE II, estimated second half of 2024.
Risk assessment for investment purposes, is extremely high. Relmada is currently a $3.00 stock, so a successful readout of RELIANCE II could propel the shares much higher. On the other hand, a failure to show efficacy, would result in the stock trading around $1.00 per share.
REL-1017 is a NMDA receptor antagonist drug, in a similar category of already approved J&J's Spravato and Axsome Therapeutics Auvelity. So having this mechanism of action successfully approved, and on the market is a positive for REL-1017. We currently hold shares in Axsome Therapeutics and Relmada Therapeutics. Chart of Relmada below, thank you for reading.
Axsome's vast pipeline includes AXS-14, (esreboxetine) a novel treatment for fibromyalgia. AXS-14 brings a new mechanism of action, a highly selective and potent norepinephrine reuptake inhibitor which was successful in phase 2 and 3 clinical trials. There are currently three FDA approved drugs to treat fibromyalgia.
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.
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 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 released their fourth quarter financial results today. Just a few highlights from the just completed impressive quarter, are below.
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.
