Tim's Market Blog
Companies Addressing Unmet Medical Needs
Saturday, October 5, 2024
Auvelity Prescription Update
Saturday, September 21, 2024
Psychedelic-Based Therapeutics
Therapies for mental health conditions are changing at rapid speed. Cybin.com (CYBN) is a biopharmaceutical company developing therapies for mental health conditions. Their lead drug CYB003 is a proprietary deuterated psilocybin analog, which the FDA has granted as Breakthrough Therapy Designation (BTD), for depression. WebMD describes Psilocybin as a schedule 1 drug. The scheduled list looks like this below.
- Schedule I: Drugs with no current medical use, high potential for abuse and/or addiction.
- Schedule II: Drugs with some medically acceptable uses, but with high potential for abuse and/or addiction. These drugs can be obtained through prescription.
- Schedule III: Drugs with low to moderate potential for abuse and/or addiction, but less dangerous than Schedule I or II. These drugs can be obtained through prescription, but generally are not available over the counter.
- Schedule IV: Drugs with viable medical use and low probability of use or misuse.
- Schedule V: Drugs with low potential for abuse (lower than Schedule IV).
Saturday, August 31, 2024
Auvelity Prescription Update
The weekly data for Axsome's lead drug Auvelity (which has been approved for Major Depression Disorder), has turned in a new weekly prescription high three weeks in row to 10,400, for the latest week ending. Data from IQVIA. Thank you for reading.
Saturday, August 17, 2024
GOLD Closes at Historical High
It's not too often we get to witness an asset that has been around for centuries, closing at an all-time high over $2500 per ounce. Gold has become a storage of wealth as the US debt continues to increase, and has historically acted as a source of value, during economic uncertainty and inflation. A weekly chart of gold, thank you for reading.
Monday, August 5, 2024
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
Saturday, July 27, 2024
Auvelity Prescription Update
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.
Saturday, July 20, 2024
Relmada Therapeutics Update
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.
Saturday, June 29, 2024
Axsome Therapeutics - ADVANCE 2 and ACCORD 2 Clinical Trials
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:
- Reduction in the CMAI (primary endpoint) vs placebo p=o.010
ACCORD 1 Results:
- Delayed time to relapse p=0.014
- Relapse prevention p=0.018
Saturday, June 15, 2024
Tracking Weekly Auvelity Prescriptions
Saturday, June 8, 2024
Relmada Therapeutics - High Risk with Potential Reward
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.
Tuesday, June 4, 2024
AXS-14 for Fibromyalgia
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.
- Lyrica (2007
- Cymbalta (2008)
- Savella (2009)