Axsome Therapeutics - Near Term Catalysts Expected

Axsome (AXSM) is expecting feedback from the FDA on two New Drug Application filings. First AXS-05 for Major Depressive Disorder, either labeling discussions, or outright approval or denial. Second, AXS-07 for Acute Migraine, which has an April 29th FDA decision date, either approval or denial.  My expectations is that we could hear feedback on both filings in this month of April. These could be the first of many New Drug Applications being filed from the company. The others, AXS-12 for Narcolepsy, AXS-14 for Fibromyalgia, and AXS-05 again, for Alzheimer's Agitation. Below is a daily chart of Axsome, thank you for reading.         

Alopecia Areata - Long Term Efficacy

There's not an FDA approved drug, for unmet medical need Alopecia available for patients at this time. Both Lilly (Baricitinib) and Concert (CTP-543) have now released long-term (52 week) Alopecia efficacy data, using the SALT score of equal to, or less than a score of 20. Note, that a SALT score 0f zero is considered a full head of hair. So the lower the score the more hair growth has been achieved while on therapy. Below is a chart of the percentage of patients achieving the SALT score of equal to or below 20, in each Lilly and Concert's long-term clinical trials.

From the chart data above, Concerts CTP-543 has 57% of patients achieving SALT 20 or lower in their open label 52 week study. The Lilly press release of their results, can be found here Lilly. Concert’s information is located at their website under Scientific Presentations. There's a strong possibility that one, or both of these oral drugs will get approved, over the next two years. Thank you for reading. 

Catalysts in 2022

Heading into 2022, there will be plenty of catalysts to look forward to. Axsome Therapeutics is in the midst of pending FDA decisions with the following.

• AXS-05 for Major Depression Disorder - Decision is forthcoming
• AXS-07 for Acute Migraine - Decision expected end of April

Additionally AXS-05 is also in a phase 3 clinical trial for the indication of Alzheimer's Agitation, with expected results in the first half of 2023. A phase 2/3 clinical trial involving AXS-05 for the indication of Smoking Cessation, is expected to be initiated in 2022. The potential approval for AXS-05 for MDD (major depressive disorder), could pave the way for future AXS-05 approvals for different indications.

Concert Pharmaceuticals CTP-543 for Alopecia Areata (an unmet need), is expected to complete at least one of the two, phase 3 clinical trials mid year 2022, with the second phase 3 completing close behind in the third quarter. These are pivotal studies that are expected to form the basis for their NDA (new drug application) for Alopecia Areata.

• Thrive AA1 phase 3 results mid year 2022
• Thrive AA2 phase 3 results 3rd quarter 2022

Thank you reading.

Alopecia Areata - CTP-543, Baricitinib, Ritlecitinib

Of the three companies addressing the unmet medical need that exits for Alopecia Areata, both Concert Pharmaceuticals, and Lilly, have officially released SALT 20 scores. With both companies completing either phase 2 or phase 3 clinical trials, we can make comparison's from the information the companies have released to the public. Lilly has completed two phase 3's Brave-AA1, Brave-AA2 with drug Baricitinib, and Concert has completed a phase 2 with CTP-543. Both have initiated two dosing arms in their trials.

Without considering safety issues for either CTP-543, Baricitinib or Retlecitinb at this time, CTP-543's 12 mg dose appears to have the strongest effect for patients with 42% achieving SALT equal or below a score of  20.

Pfizer has released Ritlecitinib phase 2/3 clinical data Abstract 41, but did not break out the SALT 20 scores, but has issued long-term 48 week results. Below is a comparison of Ritlecitinib 48 week and CTP-543 52 week (Mean SALT Score) results that the companies have released to the public. 

Note that a SALT score of zero is a full head of hair. So the lower the SALT score from baseline, the more hair growth that has occurred. The baseline score (SALT 88.1) was derived from Pfizer's phase 2 part of the phase 2/3 clinical trial. Concert has used the 12 mg dose from two clinical trials to derive a baseline average score of SALT 86.5. Thank you for reading.

AXS-12 for Narcolepsy

Today, Axsome Therapeutics announced that the first patient has been dosed with AXS-12 for Narcolepsy in the phase 3 clinical trial known as SYMPHONY. The expected completion, and readout of this clinical trail, will be in the first half of 2023.

AXS-07 for Acute Migraine

On Tuesday September 14th,  Axsome Therapeutics  announced that the New Drug Application of AXS-07 for acute migraine, has been accepted by the FDA, which has a PDUFA decision date of April 22, 2022. That's great news for the company and migraine sufferers. If approved, we could see the product on the market mid-year 2022.

Ethereum Price Target Reached

Ethereum (ETH) reached it's price target of 3900, then sold off hard. What do the charts suggest now? Corrections occur and are healthy for stocks or indexes. ETH has more than doubled in price in a very short period of time, from a low of around 1,700 to a high of 4,000, which is quite extreme. From the chart below, the previous consolidation area which runs from 2900 to 3400 should act as support for the recent pull-back. If that support is broken to the downside, then I would view that as negative sign, as Ethereum will have to find support at a lower price. Bottom line, the chart is still bullish, but expect some time to pass at this consolidation area, before another move higher. Thank you for reading.

    

   

Ethereum Price Target

The London upgrade on August 4th went smooth, and will make fees more predictable, reduce delays in processing, and decrease the amount of new coins issued.  The EIP-1559 process is explained here at Cointelegraph. Ethereum is running higher after the event, with new resistance seen at 3900. Between the current price of 3290 and 3900, there are few resistance points, based on time or volume. I see the 3900 area, where the next resistance can come into play. Chart below. Thank you for reading.

     

Ethereum Cryptocurrency

The second biggest Cryptocurrency, Ethereum , is about to get an upgrade that will be taking place on August 4th.  The London upgrade will make fees more predictable, reduce delays in processing, and decrease the amount of new coins issued.  The EIP-1559 process is explained here at Cointelegraph. Ethereum is running higher ahead of the event, with resistance at 2800 per chart below, will provide a good test at that level.

      

AXS-14 for Fibromyalgia

Another positive development involving Axsome Therapeutics and drug AXS-14, for Fibromyalgia. The FDA has given the company an expedited pathway to file a New Drug Application from the already completed, and positive phase 2 and phase 3 clinical trials. The company plans to initiate the NDA process in the fourth quarter of 2022, with expected FDA approval by third quarter 2023. This adds to their pipeline of AXS-05 for MDD, and AXS-07 for Acute Migraine. Both those drugs are already going through the FDA approval process, with AXS-05 expecting an approval by August 22nd of 2021.

Ethereum

Plenty of talk regarding the recent sell-off in Cryptocurrency. From a another post here Cryptocurrency - Bitcoin we discussed breakout levels for Bitcoin, today we are going to talk about year to date gains in Ethereum versus Bitcoin. Regardless whether you believe that Cryptocurrencies will survive in the future for commerce, or as an inflation decentralized alternative to fiat money, there is a large market for trading the asset. On May 20th, for the year Ethereum has been a stellar performer. When thinking what is Ethereum; a blockchain that can be used for sending and receiving value globally, and without third party watching or stepping in unexpectedly. Chart below with year-to-date performance. Thank you for reading.

                                 

AXS-05 Priority Review for MDD

Axsome Therapeutics issued a press release this morning with the good news that lead drug candidate AXS-05 for MDD (major depression disorder) has received Priority Review from the FDA, with a PDUFA date of 8-22-21. The Priority Review is an FDA six month review to determine whether or not to approve a drug, versus a ten month standard review. Statistically, this gives the chance of approval a higher probability then if the company received a standard ten month review timeline. This also lifts the risk the stock has been under lately, as investors have ruled out the scenario of RTF (refuse to file), and standard review from the FDA. If the drug is approved by August, then I would expect the company to start commercialization with a salesforce, and sales occurring in the fourth quarter of this year. Just a reminder, the patent for AXS-05 extends out to 2034 at the very earliest, and potentially up to 2040. So at the minimum, the company will have thirteen years of exclusivity. Below is a daily chart of Axsome. The stock had a good day today up +11% under strong volume, but I expect more appreciation for the stock over the next few weeks. Thank you for reading.