AIMT is seeking approval for AR101 as a treatment to reduce the risk of anaphylaxis following accidental exposure to peanuts in children and adolescents ages 4-17 who are severely allergic to peanuts. AIMT reported today that its BLA filing to the FDA for approval of AR101 for commercial sales, has been accepted for review by the FDA with a standard 12 month review period.
So why is the stock down 4.5% today on the news? Well, it's mixed positive news: It's good that the BLA application was accepted for review, especially given the apparent incorrect filing for PDUFA review and comments by the soon-to-be ex-FDA commissioner during the FDA shutdown, that AIMT's statements about delay in review during the shutdown were misleading. The bad news is that the timeline is a standard 12 month timeline, and not an accelerated 6-month timeline despite the fact that AR101 had Fast Track and Breakthrough Therapy Designations.
The complexity in this filing was whether AR101's therapy qualified for a standard Prescription Drug User Fee Act (PDUFA) PDUFA review, which likely would have led to a 6-month review under a typical PDUFA review since AR101 has Breakthrough Therapy and FastTrack Designations. AIMT filed its BLA late last year and paid the FDA the $1 million PDUFA review fee. However, the FDA decided that AR101 should be reviewed as a non-PDUFA allergan extract, which although it likely means AIMT will get its $1 million back, that is far less than a 6 month commercial delay will cost the company, should AR101 eventually get approved. Furthermore, the FDA will conduct an AdComm meeting for this BLA review, which was expected given that this is the first therapy that could be approved for this indication.
All in all, this is a mixed result for AIMT, which is consistent with the small downward move in the stock today, but still sets AIMT to be the leader in this indication. We have positions in AIMT in all of our funds because we think the current valuation of AIMT combined with AR101's differentiated efficacy and committed corporate partner in Nestle Health Science, make AIMT an attractive investment. We remain excited about AIMT's chances for approval with AR101, and the improved quality of life that AR101 will provide to children with severe peanut allergies and their families.