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.

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.

Axsome 2nd Quarter 2023 Financial Results

Axsome released their second quarter financial results on Monday August 7th. Just a few highlights from the just completed impressive quarter, are below. 

• Auvelity for MDD sales totaled $27.6 million for the quarter
• Sunosi for narcolepsy sales totaled $19.1 million for the quarter
• $468 million in cash on hand, end of quarter
• AXS-12 clinical trial for cataplexy, to read out in the fourth quarter, 2023
• AXS-05 clinical trial for Alzheimer's Disease Agitation, complete first half of 2024

Below are weekly prescriptions of Auvelity for MDD. Thank you for reading.  

Axsome 1st Quarter 2023 Financial Results

Axsome released their first quarter financial results on Monday May 8th. Just a few highlights from the just completed impressive quarter, are below. 

• Auvelity for MDD sales totaled $15.7 million for the quarter
• Sunosi for narcolepsy sales totaled $12.9 million for the quarter
• $246 million in cash on hand, end of quarter
• AXS-12 clinical trial for cataplexy, to read out in the second quarter

Axsome's share price has been moving steadily higher the past couple weeks. Below is a monthly chart of AXSM stock, which has just closed at it's highest level seen in the past two years. 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.         

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-12 Breakthrough Therapy Designation

The FDA has granted Axsome Therapeutics the Breakthrough Therapy Designation (BTD) for drug AXS-12 for the treatment of Narcolepsy. This was based off a phase 2 clinical trial completed in 2019, with results here AXS-12 Phase 2 Results. The designation allows for potentially quicker FDA approval of the drug, and increased communication from the FDA. The company is planning for phase 3 testing to begin in the fourth quarter of 2020.

AXS-12 Phase 2 Results for Narcolepsy

Axsome Therapeutics (AXSM) today, announced the results of their phase 2 clinical trial with drug AXS-12 (reboxetine) for Narcolepsy. The clinical trial is here clinicaltrials.gov. The trial results were better than anticipated. All comparisons of AXS-12 versus placebo were statistically significant.

• Reduction in Cataplexy attacks compared to placebo p=0.001
• Reduced daytime sleepiness compared to placebo p=0.003
• Improved cognitive function compared to placebo p=0.001
• Sleep quality and sleep related symptoms compared to placebo p=0.007

AXS-12 was safe and well tolerated.  Chart below.