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Fly News Breaks for October 7, 2019
Oct 7, 2019 | 07:12 EDT
H.C. Wainwright analyst Andrew Fein believes Friday's Biologics License Application acceptance as a "constructive step forward" for DBV Technologies (DBVT) in light of a potential perceived overhang for the program related to the Phase 3 Pepites trial. Despite Viaskin Peanut having displayed significant difference in responder rates compared to placebo in the Phase 3 Pepites trial, the question remains as to how the FDA ultimately perceives Viaskin Peanut not meeting its pre-determined 15% lower bound confidence interval between treatment groups, which was reported at 12.4%, Fein tells investors in a research note. The FDA being receptive to evaluate Viaskin Peanut's data package suggests that that Viaskin may not possibly need an 'efficacy homerun" for potential approval and that the company's approach to data analytics could be acceptable, adds the analyst. He reiterates a Buy rating on DBV shares with a $25 price target. Fein continues to believe the risk of anaphylaxis requiring epinephrine could ultimately help to give an edge to DBV's Viaskin Peanut patch over Aimmune's (AIMT) Palforzia.
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