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DBVT

DBV Technologies

$7.07

-0.04 (-0.56%)

16:03
02/13/19
02/13
16:03
02/13/19
16:03

DBV Technologies anticipates resubmission of Viaskin Peanut BLA in Q3

DBV Technologies announced that its planned resubmission of the biologics license application, or BLA, to the FDA for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in Q3. In December 2018, DBV voluntarily withdrew its BLA for Viaskin Peanut following correspondence with the FDA regarding additional data needs on manufacturing procedures and quality controls. Based on the progress in addressing the FDA's guidance, the company anticipates compiling the required information for the resubmission of its Viaskin Peanut BLA in Q3.

DBVT DBV Technologies
$7.07

-0.04 (-0.56%)

12/20/18
MSCO
12/20/18
NO CHANGE
Target $10
MSCO
Equal Weight
DBV Technologies price target lowered to $10 from $26 at Morgan Stanley
Morgan Stanley analyst Matthew Harrison said after DBV Technologies announced that it was pulling its Viaskin BLA due to issues with Chemistry, Manufacturing and Controls that in his experience CMC issues usually result in at least a one year delay to timelines. He believes the company's comments potentially suggests discrete, solvable issues versus a systemic problem, but the key question remains why FDA needed these issues addressed prior to accepting the filing versus working through them during the review. Noting that uncertainty is likely to drive DBV shares "significantly lower," Harrison lowered his price target on the stock to $10 from $26 and keeps an Equal Weight rating on DBV Technologies.
12/20/18
JMPS
12/20/18
NO CHANGE
Target $20
JMPS
Outperform
JMP calls withdrawl 'another bump in road' for DBV, keeps Outperform rating
After DBV Technologies announced that it voluntarily withdrew its Biologics License Application for Viaskin Peanut after the FDA identified deficiencies in manufacturing procedures and quality controls, JMP Securities analyst Liisa Bayko pushed out her assumption for Viaskin Peanut's U.S. launch by one year, which prompted her to lower her price target on DBV shares to $20 from $30. However, in a note titled "Another Bump in the Road As DBVT Pulls BLA to Address Manufacturing & CMC Deficiencies," she reiterated her Outperform rating on the stock as she continues to predict a 60% probability of success for the program and sees upside from current levels "once the stock settles down after the news."
01/08/19
JEFF
01/08/19
NO CHANGE
Target $8
JEFF
Hold
DBV views manufacturing issues as 'very much fixable,' says Jefferies
After meeting with the company, Jefferies analyst Eun Yang says DBV Technologies believes the Viaskin Peanut manufacturing issues raised by FDA are "straightforward" and "very much fixable." However, the company still needs to determine how much time will be required to address the issues as new data may need to be generated, Yun tells investors in a research note. She adds that DBV expects to provide a timeline for its biologics license application resubmission in February. The analyst remains neutral on shares of DBV Technologies as she thinks meaningful upside is unlikely until BLA acceptance by the FDA and/or a positive FDA panel outcome. Yang keeps a Hold rating on the name with an $8 price target.
02/11/19
STFL
02/11/19
NO CHANGE
Target $25
STFL
Hold
Stifel stays cautious on emerging peanut immunotherapy category
Stifel analyst Derek Archila said he remains cautious on long-term revenue opportunities for Aimmune's (AIMT) AR101 and DBV Technologies' (DBVT) Viaskin peanut and on the emerging peanut immunotherapy category. Childrens' adherence to medications has been challenging across many severe and chronic indications and he does not think peanut allergy treatments will buck the trend, Archila tells investors. After lowering his sales forecasts due to more conservative assumptions about adherence, Archila cut his price target on Aimmune to $25 from $33 and lowered his price target on DBV shares to $10 from $11. He maintains Hold ratings on both stocks.

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