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AIMT

Aimmune

$24.66

(0.00%)

17:55
09/13/19
09/13
17:55
09/13/19
17:55

FDA committee votes to support use of Aimmune's Palforzia for peanut allergy

Aimmune Therapeutics announced that the Allergenic Products Advisory Committee, or APAC, convened by the FDA voted to support the use of AR101, proposed trade name Palforzia, in children and teens with peanut allergy. Palforzia is a complex, biologic oral immunotherapy candidate designed to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. The APAC voted 7 to 2 that the efficacy data and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of Palforzia.

  • 13

    Sep

AIMT Aimmune
$24.66

(0.00%)

09/11/19
STFL
09/11/19
NO CHANGE
STFL
Hold
Aimmune briefing docs look 'pretty benign,' says Stifel
After the FDA posted briefing documents ahead of its Allergenic Products Advisory Committee Meeting on September 13 to review Aimmune Therapeutics' peanut allergen powder, Palforzia, Stifel analyst Derek Archila said the documents "seem pretty benign" and did not generate any new issues. He expects the focus of the Adcom to be on safety, which is not "new" news, and thinks the document release should provide some relief for shares given that the "worst case" scenario in terms of the panel may be off the table. He sees the risk/reward as less favorable once Palforzia is approved given the commercial/logistical challenges he sees ahead, added Archila, who keeps a Hold rating on Aimmune shares.
09/11/19
PIPR
09/11/19
NO CHANGE
Target $60
PIPR
Overweight
Piper says FDA briefing docs remove key underpinning of Aimmune bear thesis
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.
09/12/19
LEER
09/12/19
NO CHANGE
LEER
Outperform
Aimmune Palforzia safety bodes well for DBV'S Viaskin Peanut, says SVB Leerink
SVB Leerink analyst Joseph Schwartz notes that FDA's Allergenic Products Advisory Committee released briefing documents pertaining to its upcoming AdCom panel discussion for Aimmune's (AIMT) Palforzia on Friday. Because efficacy has been robust for Palforzia, the analyst thinks investors will be acutely focused on safety, and believes the details surrounding Palforzia safety bode well for DBV Technologies' (DBVT) Viaskin Peanut as it could provide a convenient and safer alternative for peanut allergic patients. Despite slower onset of efficacy, Viaskin Peanut's favorable safety profile could promote longer-term use which previously has been shown to continue to improve on efficacy, he contends. Schwartz has an Outperform rating on DBV Technologies' shares.
09/13/19
PIPR
09/13/19
NO CHANGE
PIPR
Aimmune's AR101 prospects derisked by FDA panel decision, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond kept an Overweight rating and $60 price target on Aimmune after an FDA's Allergenic Products Advisory Committee, or APAC, voted in favor of the company's AR101 peanut allergy drug on both efficacy and safety. The analyst said, after the vote, he "increasingly likes the chances for Palforzia approval by late January 2020 (if not sooner)." Raymond noted that the stock is likely to open sharply higher on Monday as there is a 30% short interest in Aimmune, and said he is a buyer on the open as he sees "a lot of room to go."

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FB

Facebook

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SoftBank

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GM

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ED

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COP

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AMZN

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AKS

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MT

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NUE

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STLD

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TMST

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