The race to a peanut allergy treatment just got a little more interesting, with a major player, DBV Technologies withdrawing its application to the FDA for approval of its “Viaskin Peanut” patch.
France-based DBV (NASDAQ: DBVT) said in a statement late Wednesday that its decision was based on feedback from the agency, and the company concluded that its application “lacks sufficient detail regarding data on manufacturing procedures and quality controls.” But DBV added that it won’t need to conduct more clinical trials in order to provide the additional information that the FDA wants. The company said it plans to refile its submission, though it didn’t say when.
DBV’s stock price plunged more than 65 percent this morning, down to around $4.53.
DBV experienced another setback when its patch failed to meet the main goal in its Phase 3 trial last year. Given this failure, the company, even if it did refile, still has a “significant approval risk”, wrote Kennen MacKay of RBC Capital Markets in a note this morning.
The withdrawal of DBV’s FDA submission could be good news for peanut allergy competitor Aimmune (NASDAQ: AIMT), which announced in February that its late-stage study met its main goal and that it was planning to file for FDA approval of its drug, AR-101, an oral biologic.