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. 

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.         

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.

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.

Axsome Therapeutics - An update on Progress

This will be an important year for Axsome Therapeutics, as they transform from a pure drug development company, to a drug development plus commercialization company. Below are some projected timelines that the company is planning on achieving for the first half of 2021.

• AXS-05 for MDD, new drug application to be accepted by the FDA mid April.
• AXS-07 for acute migraine, new drug application to be filed in April.
• AXS-07 new drug application to be accepted by the FDA in June.
• AXS-12 starts Phase 3 for narcolepsy in the second quarter.

                         

The weekly chart above illustrates that axsm has been trading in a range for the past ten months. As it currently stands today, the stock is at the lower bounds of the range making it a lower risk entry, for those looking to invest in the company.                               

 

AXS-07 Phase 3 for Acute Migraine (Intercept)

This phase 3 clinical trial was called Intercept, the second phase 3 clinical trial completed after the Momentum phase 3 trial for patients experiencing an acute migraine. Below are the highlights of the successful trial, and the Intercept Phase 3.

• Pain Freedom 2 hours after dosing achieved by 32.6% of patients
• Pain Freedom at 24 hours after dosing in 22.7% of patients
• Freedom from most bothersome symptoms achieved in 43.9% of patients
• Rescue medication was used by 15.3% of patients at 24 hours

Based on these results, I expect the company to prepare and file an NDA (new drug application) prior to year end. Thank you for reading.

AXS-07 Phase 3 Results for Acute Migraine (Momentum)

Axsome Therapeutics released phase 3 clinical data with AXS-07 for the treatment of acute migraine, for patients with an inadequate response to prior treatments.
The clinical trial met the two co-primary endpoints; Pain-Free at 2 hours after dose, and Absent most Bothersome Symptoms 2 hours after dose versus placebo. The clinical trial can be found here Momentum Phase 3. The trial also compared AXS-07 to Rizatriptan (a well known and effective generic drug for acute migraine) for these tough to treat patients, who have not responded to prior treatments. Comparisons below are AXS-07 versus Rizatriptan.

• Sustained pain freedom from 2 to 24 hours after dosing.  16.1% vs 11.2%  p=0.038
• Sustained pain relief from 2 to 24 hours after dosing.  53.3% vs 43.9%  p=0.006
• Sustained pain relief from 2 to 48 hours after dosing.  46.5% vs 36.5%  p=0.003
• Rescue medication was used for 23.0% of AXS-07 patients vs 34.7%  p=0.001
• Patient Global Impression of Change, AXS-07 vs Rizatriptan.                             p=0.022
• Return to normal function at 24 hours.                                                                      p=0.027

The clinical trial was a success, as AXS-07 above, compared well to the generic acute migraine drug Rizatriptan. The safety profile of AXS-o7 was similar to placebo. The company plans to file an NDA (new drug application) in the second half of 2020.

AXS-07 for Acute Migraine

Axsome’s AXS-07 is designed to treat acute episodes of migraine. The drug is a combination of Meloxicam and Rizatriptan. Rizatriptan belongs in a group called triptans which are oral drugs designed to treat moderate to severe migraine headaches. AXS-07 will also compete against a newer group of oral drugs known as CGPR inhibitors similar to Allergan's Ubrogepant. The recently announced news from Axsome, was that the company met with the FDA in May, and was told that the current phase 3 clinical trial for acute migraine AXS-07 Phase 3, if successful, would be the only clinical trial needed to file a new drug application (NDA).  The clinical trial is currently being run under a Special Protocol Assessment (SPA) which was granted by the FDA prior to the trial beginning. Axsome also announced that a 12-month safety study has commenced. Patients will roll off the current phase 3 clinical trial, and into the 12 month safety study, which is a standard requirement for a new drug application to be filed with the FDA. The company is expected to file for FDA approval in the second half of 2020, which could lead to approval in 2021. The patent for AXS-07 runs into 2036.  Thank you for reading.