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DBVT

DBV Technologies

$14.12

-0.58 (-3.95%)

, AIMT

Aimmune

$21.74

-0.15 (-0.69%)

18:23
12/19/18
12/19
18:23
12/19/18
18:23

DBV Technologies craters after pulling Viaskin Peanut application with FDA

Shares of DBV Technologies (DBVT) are down sharply in the aftermarket session after the company decided to voluntarily withdraw its application for Viaskin Peanut following advisory talks with the FDA. Viaskin Peanut had previously obtained a Fast Track and Breakthrough Therapy designation from the agency for the treatment of peanut allergy in children, but after recent consultation, the company decided that its current Biologics License Application process "lacks sufficient detail regarding data on manufacturing procedures and quality controls". The company noted however that the FDA did not respond with concerns about Viaskin Peanut clinical module and it remains hopeful that "additional information" to support the filing could be gleaned without more clinical studies. PRICE ACTION: In the afterhours session, DBV Technologies' stock price has fallen over 47% to $6.10. In related action, the shares of Aimmune (AIMT), currently in the phase 3 trial process of AR101 in peanut-allergic children, were up 15% at $25 a share. PIPER SEES "COMPETITIVE EDGE" FOR AIMMUNE: In a research note ahead of this evening's decision by DBV Technologies to withdraw the application, Piper Jaffray analyst Christopher Raymond warned that DBV Technologies' Viaskin Peanut may be excluded from the PDUFA program, resulting in "extended review time" for the trial. Raymod gave the "competitive edge" to Aimmune given the FDA's comfort level with the safety profile of AR101.

DBVT

DBV Technologies

$14.12

-0.58 (-3.95%)

AIMT

Aimmune

$21.74

-0.15 (-0.69%)

DBVT DBV Technologies
$14.12

-0.58 (-3.95%)

12/19/18
PIPR
12/19/18
NO CHANGE
PIPR
Overweight
Aimmune retains competitive edge over DBV Technologies, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond thinks the recent disclosure that DBV Technologies' (DBVT) Viaskin Peanut may be excluded from the PDUFA program would likely mean an extended FDA review time, which he said "bodes well" for competitor Aimmune (AIMT), which this morning announced the initiation of its Phase 3 POSEIDON trial assessing the efficacy of AR101 in peanut-allergic children. Given that he reads the trial start as a sign that the FDA remains comfortable with the safety profile of AR101, and his view on AR101's clinical profile, Raymond said he believes Aimmune "retains the competitive edge" over DBV. He keeps an Overweight rating on Aimmune shares.
09/13/18
STFL
09/13/18
INITIATION
Target $35
STFL
Buy
DBV Technologies initiated with a Buy at Stifel
Stifel analyst Derek Archila initiated DBV Technologies with a Buy rating and a price target of $35, saying the stock offers a "favorable" risk-reward over the next 12 months. Archila acknowledges investors' skepticism due to the Viaskin peanut missing its Phase 3 lower confidence level, but adds that his talks with regulatory experts suggest an over 50% probability that the Viaskin Biologic License Application will be accepted and yield an eventual approval.
08/20/18
JMPS
08/20/18
NO CHANGE
Target $30
JMPS
Outperform
DBV Viaskin Peanut BLA acceptance could be derisking event, says JMP Securities
After hosting meetings with Kevin Trapp, DBV Technologies' newly appointed Chief Commercial Officer, JMP Securities analyst Liisa Bayko noted the company is prepared to submit its BLA for Viaskin Peanut in October and she looks for acceptance 60 days later, which she said would be the first positive milestone for the company and could be a "meaningful derisking event." Viaskin Peanut is eligible for priority review and her expectation is that DBV will receive it, added Bayko, who reiterated her Outperform rating and $30 price target on the shares.
04/18/18
04/18/18
NO CHANGE
Target $37

Buy
Pediatric allergist sees both DBV, Aimmune winning approval, says Jefferies
Jefferies analyst Eun Yang hosted a discussion panel with a pediatric allergist who believes both both DBV Technologies' (DBVT) Viaskin Peanut and Aimmune's (AIMT) AR101 will be approved by the FDA. The allergist thinks Viaskin would be preferable due to its lower burden of monitoring and AR101 would be preferred due to its stronger efficacy, Yang tells investors in a research note. The doctor believes choice of treatment, if both are approved, will depend on a patients' goal of treatment and preference. Yang has a Buy rating on DBV Technologies with a $37 price target.
AIMT Aimmune
$21.74

-0.15 (-0.69%)

12/13/18
CANT
12/13/18
NO CHANGE
Target $64
CANT
Overweight
Aimmune current range an attractive entry point, says Cantor Fitzgerald
Cantor Fitzgerald analyst Charles Duncan sees the current Aimmune Therapeutics trading range as an attractive entry point. He reiterates an Overweight rating on the shares with a $64 price target after attending the company's analyst day.
12/13/18
GSCO
12/13/18
INITIATION
Target $32
GSCO
Neutral
Aimmune initiated with a Neutral at Goldman Sachs
Goldman Sachs analyst Paul Choi initiated coverage of Aimmune Therapeutics with a Neutral rating and $32 price target. The analyst thinks the company's peanut allergy treatment AR101 is more than likely to be approved, but he expects a "relatively slow launch."
12/13/18
PIPR
12/13/18
NO CHANGE
Target $60
PIPR
Overweight
Piper remains buyer of Aimmune into 'catalyst-rich' 2019
Piper Jaffray analyst Christopher Raymond says "strong support" from allergists at Aimmune Therapeutics' "positive" investor day. The analyst continues to like the stock setup and says he remains a buyer of the stock into a "catalyst-rich" 2019. Raymond keeps an Overweight rating on Aimmune with a $60 price target.

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