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.
