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.