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Fly News Breaks for October 4, 2019
Oct 4, 2019 | 13:24 EDT
Piper Jaffray analyst Christopher Raymond says the FDA's acceptance of competitor DBV Technologies' (DBVT) Biologics License Application submission for Viaskin Peanut does not change his positive outlook on Aimmune Therapeutics (AIMT). Today's decision means that DBV has addressed the FDA's manufacturing-related concerns that precipitated withdrawal of the original BLA submission late last year, Raymond tells investors in a research note. The analyst, however, still thinks Viaskin Peanut's approvability "remains open for debate given its relatively meager effect size" and failure of the Phase Pepites trial. Further, DBV still faces an FDA panel before an approval decision, and even if it ultimately wins FDA approval, Aimmune's Palforzia "retains the clear competitive edge," contends Raymond. The analyst keeps an Overweight rating on shares of Aimmune with a $60 price target. The stock in afternoon trading is down 4.5% to $22.46.
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