- DBV Technologies' shares dropped nearly 70% on an unexpected update that confirms the company voluntarily withdrew its Biologics License Application for its peanut allergy treatment, Viaskin Peanut. The company stated it will provide more details in the first quarter of 2019.
- Based on verbal and written correspondence with the Food and Drug Administration, DBV confirmed its application "lacks sufficient detail regarding data on manufacturing procedures and quality controls." There were no concerns over safety and efficacy, the company said, and additional clinical trials should not be needed.
- DBV will work with the FDA to resubmit "as quickly as possible". Competitor Aimmune Therapeutics, meanwhile, benefited from the withdrawal, with shares jumping up about 13% Thursday.
DBV and Aimmune have been working to make it to market with a treatment for peanut allergies. DBV had edged Aimmune to reach regulator's desks, submitting its BLA in October despite a Phase 3 trial setback in which Viaskin Peanut didn't hit its primary objective.
Withdrawal of Viaskin Peanut, however, could mean that Aimmune's AR101, which met its goal in the Phase 3 PALISADE study, could claim pole position.
While the withdrawal of the BLA was voluntary, Eun Yang, an analyst at Jefferies, noted the FDA provided the company with the choice of withdrawing or continuing and potentially receiving a Refusal-to-File letter.
"Withdrawal of the Viaskin Peanut BLA … was unexpected," Yang wrote in a note to investors. "Lack of details on next steps to address the manufacturing issues raised by the FDA and unclear timing of BLA resubmission indicates to us that the issues could be complex and/or time-consuming to resolve," she added.
Joseph Schwartz of Leerink predicts a Viaskin Peanut launch for 2021 following a resubmission in the second half of 2019.
DBV and Aimmune aren't the only contenders for developing a peanut allergy treatment, but are currently closest to market.
AnaptysBio has published Phase 2a data for etokimab in peanut allergy, but sparked confusion by leaving out four patients from the interim analysis of a study that only included 20 adults. The company has since "de-prioritized" future company-sponsored clinical studies of the drug in peanut allergy.
Peanut and tree nut allergies more than tripled in U.S. children between 1997 and 2008.