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.

CTP-543 - Phase 3 THRIVE AA1 Results

Today Concert Pharmaceuticals released the first of two phase 3 clinical trials for the unmet medical need Alopecia Areata.  The results were impressive and mirrored their phase 2 clinical trial. The phase 3 had 41.5% of patients in the 12 mg group achieving the SALT 20 or lower score after 24 weeks of treatment. Note that the lower the SALT score the more head of hair that has grown back.  The percentage of the 8 mg group of patients achieving a SALT score of 20 or less was 29%. Adverse events were reported inline with their phase 2 clinical trial. Below are results from three companies targeting Alopecia with their respective drugs. 

Concert's CTP-543 (green bars in graph) is the most effective in the high dose of 12mg and their lower dose of 8mg versus the others, high and low dose. The second phase 3 THRIVE AA2 will read out in the third quarter. Thank you for reading.

 

CTP-543 - Patent Trial and Appeal Board Decision

Yesterday the PTAB (Patent Trial and Appeal Board) ruled on a PGR (Post Grant Review) in favor of Concert Pharmaceuticals. The petitioner Incyte Corporation, has not demonstrated beyond a preponderance of the evidence that each challenged claims is unpatentable. Incyte Corporation could appeal to the Federal Court system, but that can take several years to play out, and may come to the same conclusion that the PTAB just did.

CTP-543's patent runs to 2037, so plenty years ahead, even considering that Concert does not plan to submit a New Drug Application to the FDA until the first half of 2023, with expected approval, either end of 2023, early 2024. 

CTP-543 would be addressing the unmet need of Alopecia Areata, an autoimmune disorder that causes your hair to come out, and which there is not an FDA approved oral treatment available at this time. Phase 3 clinical trial Alopecia data from Concert is expected in the coming weeks. Concert's stock had a positive reaction to this news, chart below. Thank you for reading. 

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.