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Fly News Breaks for September 11, 2019
AIMT
Sep 11, 2019 | 10:14 EDT
Piper Jaffray analyst Christopher Raymond said the FDA's briefing documents for its upcoming panel review of AR101, now called Palforzia, are "benign, even surprisingly positive," and he feels even more confident about the chances for approval of Aimmune's peanut allergy treatment. A key point in the documents is that the FDA is directing the panel to look at reactions to accidental exposures as perhaps a better predictor of real world utility than a double blinded placebo controlled food challenge, said Raymond, who contends that this "singular statement...removes a key underpinning from the bear thesis which points to the imbalance of systemic allergic reactions." The analyst, who anticipates a 2020 approval and revenue of over $1.5B by 2025, keeps an Overweight rating and $60 price target on Aimmune shares.
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