Shares of small-cap biopharma company DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT) were advancing strongly Thursday in reaction to an announcement regarding a regulatory filing for its lead product candidate.
DBV said late Wednesday it has submitted its Biologic License Application, or BLA, for Viaskin Peanut, which is being evaluated for treating peanut-allergic children ages 4-11.
Viaskin Peanut, an epicutaneous immunotherapy, is DBV's proprietary investigational platform designed to leverage the skin to activate the immune system and induce desensitization to allergens.
In December 2018, the company voluntarily withdrew its prior BLA submission after the FDA communicated the need for additional data on manufacturing procedures and controls.
The agency did not raise any issues related to the clinical module of the BLA.
Why It's Important
The resubmission is an important regulatory milestone for the company, bringing it one step closer to potentially bringing a peanut allergy drug to patients.
Aimmune Therapeutics Inc (NASDAQ: AIMT) has a rival product candidate for the same indication in AR101. The FDA accepted the BLA for the asset in January and will review the BLA by January 2020.
DBV's Viaskin Peanut has received both Breakthrough and Fast Track designations.
The investigational asset is the most advanced product candidate in DBV's pipeline. It is being evaluated in a separate Phase 3 trial in children ages 1-3 and a Phase 2 trial in adolescents and adults.
"We look forward to working with the FDA throughout its review process," DBV CEO Daniel Tassé said in a statement.
DBV shares were trading higher by 10.94% at $10.13 at the time of publication Thursday.
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