Stifel downgraded DBV Technologies (NASDAQ:DBVT) to “hold” from “buy” and slashed its price target to $11 from $35 after the company withdrew the BLA for its Viaskin peanut allergy treatment after a meeting with the FDA. The stock closed at $14.15 on Dec. 19.
Analyst Derek Archila writes that the company’s application probably lacked details around manufacturing procedures and quality controls (CMC).
“We are surprised this type of information would not have been discussed with the agency prior to the BLA submission (DBV has fast track and breakthrough status, which grants increased agency interaction) to ensure the required data was part of the package,” he added.
Although management claims there were no questions regarding Viaskin peanut’s clinical module (efficacy and safety), “we believe the lack of specifics around the CMC requirements and the fact management could not provide visibility on timelines makes this a hard story to invest in” at the current time, he said.
Mr. Archila is conservatively assuming a one-year delay in re-filing the BLA, and “believes investors will worry about the company’s ability to execute, given the news.”