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AIMT

Aimmune

$22.06

2.26 (11.41%)

08:31
09/11/19
09/11
08:31
09/11/19
08:31

FDA to ask panel if Aimmune peanut allergy treatment data support approval

The FDA has posted briefing documents ahead of its Allergenic Products Advisory Committee Meeting on September 13, which is being called to review the biologics license application submitted by Aimmune Therapeutics for its peanut allergen powder with the proposed trade name Palforzia. The Committee will be asked whether the efficacy and safety data support licensure of Palforzia as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients 4 through 17 years of age with a confirmed diagnosis of peanut allergy. The FDA summary of the data supporting the application states in part: The pre-specified efficacy success criterion for the Phase 3 study, ARC003, was met for subjects 4 through 17 years of age. The difference between Palforzia and placebo groups in proportion of subjects able to ingest 600 mg of peanut protein with no more than mild symptoms during the DBPCFC at study end was 63.2% with a 95% CI. While not evaluated as an efficacy outcome, adverse events related to subject-reported accidental food allergen exposures decreased from 11.5% during up-dosing to 9.0% during maintenance in the Palforzia treatment group, further suggesting that Palforzia protects against allergic reactions following accidental exposure...Treatment with Palforzia resulted in an increased risk of systemic allergic reactions, some of which resulted in increased epinephrine use compared to the placebo treated group. In the controlled population, during initial dose escalation and up dosing combined, 9.4% of subjects taking Palforzia reported systemic allergic reactions while 3.8% of subjects in the placebo group did."

  • 13

    Sep

AIMT Aimmune
$22.06

2.26 (11.41%)

08/05/19
PIPR
08/05/19
NO CHANGE
Target $60
PIPR
Overweight
Aimmune FDA panel could break downward share trend, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Aimmune Therapeutics with a $60 price target after traveling with management. Despite the recent share performance, new money investment in this name, "even in the teeth of the current trend," may make sense, Raymond tells investors in a research note. The analyst thinks the company's September 13 FDA panel meeting for AR101 in peanut allergy "could serve as the catalyst to break the stock's downward trend." Further, Raymond feels "increasingly confident" in a "strong" commercial launch for AR101. Investors "who can look past the scary technicals can be rewarded here," he says.
08/05/19
HCWC
08/05/19
NO CHANGE
Target $25
HCWC
Buy
H.C. Wainwright reiterates Buy on DBV ahead of expected BLA resubmission
H.C. Wainwright analyst Andrew Fein says that as DBV Technologie (DBVT) moves forward towards an anticipated Biologics License Application resubmission for Viaskin Peanut in Q3, he continues to be supportive of the overall value, safety, and efficacy of the Viaskin Peanut program. Following organizational updates, a "straightforward BLA resubmission could refresh investors' confidence in management, while addressing the regulatory overhang," Fein tells investors in a research note. He reiterates a Buy rating on DBV shares with a $25 price target. His confidence in the Viaskin Peanut program has been based on "exceptional safety and sufficient efficacy to manage the risk of accidental exposure." The analyst believes these properties differentiate Viaskin Peanut from the peanut oral immunotherapy being developed by Aimmune (AIMT).
08/09/19
RBCM
08/09/19
NO CHANGE
Target $50
RBCM
Outperform
Aimmune price target lowered to $50 from $58 at RBC Capital
RBC Capital analyst Kennen MacKay lowered his price target on Aimmune to $50 after its Q2 earnings miss, also reducing his launch expectations for AR101 based on the analysis of the "recent comparable drug launches into indications with a similar unmet need." The analyst still keeps his Outperform rating on the stock and sees AR101 as well positioned to "disrupt and build the peanut allergy desensitization market".
09/09/19
BARD
09/09/19
NO CHANGE
Target $64
BARD
Outperform
Aimmune added as a Fresh Pick, AdCom a binary event, says Baird
Baird analyst Brian Skorney Added Aimmune as a Fresh Pick ahead of Friday's AdCom event. The analyst said it will be mid-week briefing documents followed by Friday's meeting which he expects to be a binary event. He believes it should be a positive catalyst which could yield a 20-30% upside from its current price and he noted AR101 has shown robust efficacy in increasing the amount of peanut protein tolerated by patients during it PALISADE trial. Skorney reiterated his Outperform rating and $64 price target on Aimmune shares.

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ICAD

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