Ethereum -Technical Analysis

Ethereum the second largest cryptocurrency behind Bitcoin, has shown a nice return in 2023, higher by around +28%. But, as asset prices rise, pullbacks become inevitable, and healthy for further gains ahead. Fibonacci retracement is a common way of understanding the extent to which an asset is retracing the most recent high or recent low. Below is a daily chart of Ethereum, with Fibonacci. Typically I would expect a healthy pullback to the 50% retracement level, which would put ETH at the 1431. Also possible, is the present pullback, at the 38.2% level could hold as support before the next move higher. Daily chart below.    

It will be interesting to see where Ethereum trades from here. If the 38.2 % pullback holds or retraces lower to the 50% fibonacci level around 1431. Thank you for reading.

Auvelity - One Month Prescription Data

The first month, of their first quarter of 2023 prescription data from IQVIA is below. Note that there was a holiday in the week of 1/27/23 which may have accounted for the slight drop. Axsome's launch of Auvelity for MDD, has been strong to date.

1/06/2023 1300

1/13/2023 1650

1/20/2023 1835

1/27/2023 1750

Auvelity Week Twelve Prescriptions

Axsome Therapeutics, week twelve prescriptions for Auvelity, is the second week of a new quarter of revenue, for the companies recently approved MDD drug. These first two weeks of the first quarter of 2023 will also start the first complete, 12 week quarter for Auvelity since approval. The launch is off to a good start. Stats from IQVIA.

Week 11  01/06/23 = 1300

Week 12  01/13/23 = 1650

2023 - Asset Class Performance

A quick look at a two week chart of returns for some of the major asset classes; stocks, bonds, gold, ethereum, and bitcoin. Easy to see in the chart below, all five of those asset classes have appreciated quite substantially in the first two weeks of 2023.

     

Are the markets factoring in tame inflation (CPI readings) moving forward, and the federal reserve halting or reversing interest rates over the next few months?  That seemed to spark the rally in assets, after the latest CPI reading. That assumption may be early, and why monitoring the monthly inflation data, will be important. Thank you for reading.

Auvelity Week Seven Prescriptions

Axsome Therapeutics week seven (full week) of Auvelity prescription data for MDD, came in > than 1000, reported by IQVIA. The 1000 for week seven was a 30% increase from week six's 770, released on 12/2/22. The impressive weekly data so far looks like this below.

Week 7  12/09/22 = 1000

Week 6  12/02/22 = 770

Week 5  11/25/22 = 510

Week 4  11/18/22 = 582

Week 3  11/11/22 = 360

Week 2  11/04/22 = 308

Week 1  10/28/22 = 158

AXS-05 Phase 3 Alzheimer's Agitation Results

Today, Axsome Therapeutics released top line results from their ACCORD, phase 3 Alzheimer's Agitation study with drug AXS-05. The results met both primary and secondary efficacy endpoints below.

 

  -  Delayed time to agitation relapse vs. placebo p=0.014

  -  Prevented relapse of agitation vs. placebo p=0.018

Other important endpoints:

  -  Alzheimer's agitation, CMAI total score, open label p=0.001

These results bode well with the previously completed ADVANCE-1 phase 2/3 study released in 2020. Axsome plans to take these results to the FDA, with the intent to file a supplemental New Drug Application, (sNDA). Alzheimer's Agitation is an unmet medical need, with no treatments currently approved. With AXS-05, the likelihood for patients remaining in their homes becomes more favorable, easier on caregivers, reducing overburdened nursing care facilities. We previously wrote about this unmet need here Agitation in Alzheimer's Disease -An Unmet Need Part 2. Chart of Axsome below. Thank you for reading.

Auvelity Week 4 Prescriptions

Again, courtesy of research analyst Mizohu, is Auvelity compared to other recent Major Depression drug launches. The table is somewhat hard to read, the week 4 change in total prescriptions (TRx's via IQVIA) is 17% w/w change (308 to 360), which is impressive. We will keep tracking Auvelity's launch, but for right now, it's very positive. Again, thanks to Mizuho for the market research. Please click on the table below, for better viewing.  

Auvelity Week Two Prescriptions

When looking at the launch of Axsome's Auvelity for MDD, it is important to note the week 1 to week 2 change of prescriptions percentage. This could give us a general indication of trajectory of public uptake. From below, and courtesy of research analyst Mizohu, is Auvelity compared to other recent Major Depression drug launches. The table is somewhat hard to read, the week 2 change from week 1 in total prescriptions (TRx's via IQVIA) is 394% w/w change (32 to 158), which is impressive. We will keep tracking Auvelity's launch, but for right now, it's very positive. Again, thanks to Mizuho for the market research. Please click on the table below, for better viewing. 

Relmada Phase 3 MDD Results

Relmada Therapeutics (RLMD) has been working on a new MDD drug (major depressive disorder) known as REL-1017, an NMDA (NMDAR) channel blocker. The company released top-line results on Thursday October 13th. The top line results revealed that the drug showed to be effective (-14.9 reduction from baseline), but the placebo group also displayed a reduction in depressive symptoms (-13.9 from baseline) on the MADRS 10 Total Score. The .9 differential between the two groups at day 28 was deemed to be a clinical trial failure. 

The company did a secondary clinical trial analysis, and determined that when excluding clinical sites with implausibly high or low placebo responses (4-5 of the total sites), showed a meaningful difference between REL-1017 and placebo to the effect of 4.9 points on the MADRS 10 versus placebo p=0.05. 

Based on the results above, Relmada may have to run another phase 3 clinical trial for MDD to proceed to an NDA filing. The timeline to starting and completing would be around one year based on this just completed clinical trial, then filing an NDA would require additional time. Most likely to get REL-1017 approved for MDD, could take two years from the start of an additional clinical phase 3 MDD trial to FDA approval, if everything goes well. Note that Relmada does not have Breakthrough Therapy Designation (BTD) for REL-1017, MDD. 

Axsome Therapeutics Auvelity, was just granted FDA approval for MDD in August 2022, with a planned launch early 4th quarter 2022. Auvelity, provides a fast-acting oral anti depressant therapy. REL-1017 would have competed directly with Axsome's Auvelity, as both provide a fast acting response, which is an unmet need to current MDD drugs on the market. Axsome's stock had an upward response after the Relmada results were revealed, while Relmada chart below, sold off.                                  

Auvelity Receives FDA Approval for MDD

Today Axsome Therapeutics announced the FDA has approved their drug, AXS-05 for Major Depressive Disorder. The commercialized product (AXS-05) will be named Auvelity. This is a good day for patients suffering from MDD, as Auvelity is a new oral mechanism of action, which acts very quickly, and has shown durability in clinical trials, that led to the FDA approval. The company plans to start selling the product early in the fourth quarter. The press release is here Auvelity FDA Approval.  The stock had a very strong day as expected, up +40%. Below is a daily chart of Axsome.                                            

                               

Alopecia - Clinical Trial Results

Three companies have released phase 3 clinical results with their respective drugs for Alopecia, and plan to file for FDA approval for this unmet need. Graph below of the clinical results, showing what each companies highest dose achieved in their phase 3.                                                                                        

The above chart shows, the effectiveness that each drug to the SALT 20 scoring criteria. A lower SALT from baseline signifies that there was more hair growth while on therapy. The highest percentage of test participants that achieved under or equal to the SALT 20 score, was Concert's CTP-543 12mg, with 38% and 41% of patients scoring under, in two phase 3 clinical trials. The hope is that those suffering from Alopecia will have a selection of at least two effective drugs for their disease. Thank you for reading.

AXS-05 Proposed Labeling for MDD Indication

Axsome's New Drug Application (NDA) for Major Depressive Disorder, has progressed to product labeling discussions with the FDA.  This puts Axsome a step closer to potential FDA approval. The company released the following SEC document below. 

On June 24, 2022, Axsome Therapeutics, Inc. (the “Company”) received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.

Axsome's stock had a good week based on the document that the company filed on June 24th, 2022. Weekly chart below, AXSM stock advancing 66.15% under heavy volume.