Aimmune (AIMT 22.19, +0.71, +3.31%) reported positive phase 3 data out of
Europe for its oral peanut immunotherapy AR101 this morning.
The study met its primary endpoint when the median tolerated dose of peanut protein for AR101-treated patients improved 100-fold, from 10 mg at baseline to 1,000 mg at exit. Importantly, the data did not bring up any safety concerns regarding AR101, which is on track to become the first desensitization therapy for peanut allergy in both the U.S. and Europe.
Management said that the data is remarkably consistent with the phase 3 data the company reported in the US thirteen months ago. Aimmune said it remains on track to submit its Marketing Authorization Application to the European Medicines Agency in mid-2019.
The stock has underperformed amid uncertainty regarding the timing of the regulatory path.
Last week, the company announced that the FDA accepted its Biologics License Application (BLA) for AR101. The acceptance was delayed by the government shutdown. The FDA expects to convene an advisory committee meeting to discuss the application. A decision may take until January 2020, which disappointed investors looking for a more expedited review. The FDA granted AR101 Breakthrough Therapy Designation in June 2015 for peanut-allergic children and adolescents ages 4-17, which was preceded by the granting of Fast Track Designation in September 2014.
Analysts agree Aimmune's oral peanut therapy is safer and more efficacious than DBV Technologies' (DBVT) Viaskin Peanut therapy patch. Following discussions with the FDA, DBV Technologies withdrew its BLA due to insufficient data on manufacturing procedures and quality controls in December. DBV plans to resubmit its application to the FDA in the third quarter of this year.
Aimmune notes that over 1.6 mln kids and teens are affected by peanut allergy in the US, and that number is on the rise. Even though AR101 has blockbuster potential given the high unmet need, the stock remains out of favor given uncertainty regarding the timing of regulatory approval and the risk of commercialization.
The company has over $300 mln in cash -- enough to launch AR101 and fund its pipeline, which includes AR101 combined with a monoclonal antibody and an egg allergy immunotherapy.
Aimmune has an enterprise value of just over $1 bln. Nestle Health Sciences owns almost 19% of the company. Meanwhile, nearly 20% of the 40 mln share float was recently sold short.
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