DBVT - DBV Technologies falls after updates on Viaskin Peanut patch

DBV Technologies (DBVT -41.1%) ADRs have lost sharply after the company announced its plans to begin a new Phase 3 pivotal trial for the modified Viaskin Peanut patch. The study for the intended patient population will be designed to evaluate the modified Viaskin Peanut (mVP) patch, which is circular and 50% larger than the current Viaskin Peanut (cVP) patch, DBV (NASDAQ:DBVT) said Monday after the close. The company has decided not to pursue a stepwise approach for the development of Viaskin Peanut, as requested by the FDA in October. “DBV does not believe this approach to be in the best interest of patients due to the significant time delays associated with FDA review of a resource dependent (non-PDUFA) product,” the company said, detailing its reasons for the pivotal study. French biotech also says it is finalizing the protocol for the late-stage study and expects to submit it to the FDA

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DBV Technologies falls after updates on Viaskin Peanut patch