Auvelity FDA Approval for Alzheimer's Disease Agitation

We first wrote about the unmet need for ADA here Agitation In Alzheimer's Disease - An Unmet Need. Axsome Therapeutics was given approval for the indication of Alzheimer's Disease Agitation (ADA), with drug Auvelity from the FDA. This addresses an unmet need, and the first non-antipsychotic approval for ADA. This is the second approval for Auvelity, as it was granted approval for MDD in 2022. Axsome currently has three in-house drug approvals as follows. 

• Auvelity for MDD  8/19/22
• Symbravo for Acute Migraine  1/30/25
• Auvelity for ADA  4/30/26

The stock as expected, had a positive reaction to the news per chart below. Thank you for reading.

Axsome Therapeutics - Market Capitalization In Charts

A stocks market cap is simply the current stock price multiplied by the current number of shares outstanding, and is a rough assessment of the companies worth. 

Axsome has received FDA approval for in-house developed Auvelity (depression) and Symbravo (migraine). The company also has a pipeline of drugs in various stages with the notable exception of AXS-05, which has pending approval for Alzheimer's Disease Agitation (ADA). That pending approval has a decision date of April 30th. 

With potential AXS-05 approval for ADA, the likelihood for patients remaining in their homes becomes more favorable, easier on caregivers, and reducing overburdened nursing care facilities. Below is a chart of Axsome over the past two years, with market cap in red at various stock prices. Thank you for reading. 

Axsome 4th Quarter Financial Results

Today, Axsome Therapeutics released fourth quarter 2025 financial results. Another impressive quarter as the company is getting closer to becoming profitable, on a cash and earnings per share basis. 4th quarter highlights below.  

• FDA decision date of 4/30/26 for Alzheimer's Disease Agitation 
• $196 million in fourth quarter total revenue
• 65% year over year revenue growth
• 322.9 million in cash
• 50,882 million shares outstanding

Daily chart below of Axsome Therapeutics. Thank you for reading.

Axsome 2nd Quarter Financial Results ($103.59)

Axsome Therapeutics is getting closer to becoming a profitable company, on a cash and earnings per share basis.  An impressive 2nd quarter, with highlights below. 

• On target to file a supplemental NDA for Alzheimer's Agitation 3rd quarter
• 150 million in second quarter revenue
• 303 million in cash

Chart below of Axsome Therapeutics, with corrections that the stock has endured the last few years. The average correction falls in the range of around 30%. Thank you for reading.

Auvelity Prescription Update - 2nd Quarter

Axsome Therapeutic's drug, Auvelity was approved for depression in 2022, and completed it's first full year of commercialization in 2023. The chart below is quarterly prescription data derived from a couple different sources, Bloomberg and IQVIA. The numbers are climbing from quarter to quarter, which is positive. The second quarter of 2025 numbers have not been released yet, so a rough estimate has been created based on data tracking. See chart below of prescription data. Axsome reports second quarter results on August 4th.

Auvelity Prescription Update

Axsome Therapeutic's drug, Auvelity was approved for depression in 2022, and completed it's first full year in 2023. The chart below is quarterly prescription data derived from a couple different sources, Bloomberg and IQVIA. The numbers are climbing from quarter to quarter, which is positive. The first quarter of 2025 numbers have not been released yet, so a rough estimate has been created. See chart below. Axsome reports first quarter results on May 5th.

Solriamfetol for ADHD Phase 3 Results

Axsome released phase 3 clinical data from the (FOCUS) study with drug Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD), with results being statistically significant, rated under the AISRS (primary endpoint) versus placebo with 150mg dose.

FOCUS Phase 3 Results:

• AISRS compared to placebo p=0.039 
• CGI-S compared to placebo p=0.017

The company will next have to run a pediatric phase 3 study scheduled for 2025. If positive then can submit to the FDA a new drug application. The advantage over current treatments, is that Solriamfetol is considered a non-stimulant drug, and potential improvement from a safety profile from currently approved ADHD drugs on the market. Thank you for reading.

Axsome Fourth Quarter Financial Results

Axsome released 4th quarter financial results today, a couple of highlights from the quarterly and year end release. 

• ADHD phase 3 results, first quarter of 2025
• AXS-05 for Alz Agitation NDA to be submitted 2nd half 2025
• AXS-12 for Narcolepsy NDA to be submitted 2nd half 2025
• $315 million in cash, end of 2024

Good quarter, and great 2024 completed. The stock is at an all-time high level around $130.00 per share chart below. Thank you for reading. 

 

Symbravo Receives FDA Approval for Acute Migraine

Axsome Therapeutics has received FDA approval for migraine drug AXS-07, or known commercially now as Symbravo. The drug's patent extends out to 2040, so there will be plenty years of runway for commercialization. The list of approved drugs that address unmet medical needs now extends to three, which include Auvelity, Sunosi, and now Symbravo. The company is operating at a very high level, of advancing through clinical trials to FDA approval. Click on chart below, as Axsome stock has closed at an all-time high price. Thank you for reading. 

AXS-05 for Alzheimer's Agitation - Phase 3 Results

Axsome released data for unmet medical need, Alzheimer's Agitation. The therapy may promote easier caregiver duties, so the person with Alzheimer's they are caring for, can remain in their home surroundings, rather than institution. The company hit on one of the two clinical trials completed. The studies were ADVANCE2 and ACCORD2, with the ACCORD2 trial delivering statistical significant results that should lead to a New Drug Application (NDA) and potential FDA approval. The company plans to file the NDA in the second half of 2025. With the completion of these two clinical trials, the company will have three positive studies, results 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

ACCORD 2 Results:

• Delayed time to relapse p=0.001
• Relapse prevention p=0.001

The safety profile was in line with previous company studies, which could indicate the absence of a black box label. Patent for AXS-05 runs from 2034 to 2043. Thank you for reading.

AXS-12 Long-Term Phase 3 Study

Axsome Therapeutics completed their phase 3 12 month long-term study with Narcolypsy drug candidate AXS-12. The results confirmed the prior phase 2 and phase 3 studies completed. 

• Phase 3 long-term reduced cataplexy attacks vs. placebo (p=0.017)
• Phase 3 significantly reduced cataplexy attacks vs. placebo (p=0.018)
• Phase 2 significantly reduced cataplexy attacks vs. placebo (p=0.001)

Based on these results, Axsome will file a new drug application (NDA) with AXS-12 for Narcolypsy patients experiencing cataplexy first half of 2025, and if approved will be on the market in 2026. AXS-12 has patent to 2039. This will be a smaller revenue producer compared to what Auvelity revenues will be producing for MDD, but still significant for a small but growing biotech company. Chart of Axsome below show's stock hovering around $100 per share. Thank you for reading.

Axsome Therapeutics (AXSM)

Axsome will report 3rd quarter results on November 12th. What to listen for during the conference call will be the pending ADVANCE2 and ACCORD2 clinical trial readouts for Alzheimer's Agitation, an unmet medical need. Previously the company guided for the clinical trial results by year end 2024. 

Prescription data for Auvelity treating MDD, is still progressing strong and growing as seen from the chart below. The chart below depicts Auvelity's drug launch for MDD versus other recent drug launches at similar time frames. I'm using Morgan Stanley's Research chart below, capturing data from IQVIA on a quarterly basis, so credit goes to them for this data. Clicking on chart will show Auvelity's launch for MDD (in blue) has been strong in comparison to Trintellix, and Viibyrd, which are other drugs approved to treat the same symptoms. Thank you for reading. 

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.

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.

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

Both ADVANCE 1 and ACCORD 1 results bode well for the eminent release of the two follow on clinical trials ADVANCE 2 and ACCORD 2, expected in the second half of 2024. Both follow-on clinical trials will be using the same endpoint criteria as the previous. Thank you f0r reading.

Tracking Weekly Auvelity Prescriptions

Axsome Therapeutics lead drug Auvelity, recorded a new prescription high of 9,125 this past week. The FDA approved Auvelity for MDD late 2022, and commercial launch followed. Data reported from IQVIA. Weekly prescription chart below. Thank you for reading.

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. 

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)

Axsome currently has AXS-14 patent pending, Google Patent. If approved, the patent would expect to extend out to around 2042. Another smaller company Tonix is expected to apply for FDA approval for their fibromyalgia drug, TNX-102 SL, in the second half of 2024. Below is a chart of Axsome which has trended around the $75.00 level most of 2024. Thank you for reading.

Axsome First Quarter Financial Results

Axsome Therapeutics released impressive first quarter results this morning. The biggest positive was that four Alzheimer's Agitation clinical trials are to be completed, which will lead to a NDA (new drug application) for that indication. Two clinical trials ADVANCE 1 and 2, have been designed as parallel assignment, and two clinical trials ACCORD 1, and 2, as randomized withdrawal trials. Both ADVANCE 1 and ACCORD 1 have successfully completed. ADVANCE 2 and ACCORD 2 are expected to complete this year. Upon completion, an NDA will be filed with the FDA for approval. Below are some positive points learned from the company's conference call this morning. 

• Auvelity for MDD sales totaled $53.4 million for the quarter
• Sunosi for narcolepsy sales totaled $21.6 million for the quarter
• A second GPO (group purchasing organization) signed
• 331 million in cash on hand, end of first quarter

AXS-12 for Narcolepsy - Phase 3 Results

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.

• Phase 3 significantly reduced cataplexy attacks vs. placebo (p=0.018)
• Phase 2 significantly reduced cataplexy attacks vs. placebo (p=0.001)

Based on these two clinical trials, and prior clinical and non-clinical studies, Axsome plans to submit an NDA (new drug application) with approval for patients with Narcolepsy experiencing Cataplexy attacks. The gating factor will be the long-term safety data, that is still ongoing with an expected completion date by December 2024. 

Weekly chart of Axsome below. Thank you for reading.