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DBVT

DBV Technologies

$7.01

-0.1 (-1.41%)

, AIMT

Aimmune

$23.84

-0.87 (-3.52%)

16:12
02/13/19
02/13
16:12
02/13/19
16:12

DBV jumps 41% to $9.96 after update on Viaskin Peanut filing

Shares of DBV Technologies (DBVT) jumped after the company said that its planned resubmission of the Biologics License Application to the FDA for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019. "We appreciate the detailed feedback the FDA provided in December 2018, which has allowed us to make meaningful headway in addressing the information requests needed for a BLA resubmission," said Daniel Tasse, CEO of DBV Technologies. "We are working diligently on our Viaskin Peanut BLA, bringing us one step closer to potentially providing an FDA-approved treatment for peanut-allergic children and their families." 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 the third quarter of 2019," DBV said in a statement. The stock in after-hours trading jumped 41%, or $2.91, to $9.96. In an interview with Bloomberg, Tasse added, "I assume people will be pleased that we will file in 3Q which is, by our standard, a reasonable amount of time...We are in a position where we will have cash into 4Q, so on the other side refiling the submission, and we will look at the right opportunity to raise capital as circumstances play out." Aimmune Therapeutics (AIMT), which is also developing a treatment for peanut allergy, is trading down in after-hours 31c to $23.50.

DBVT

DBV Technologies

$7.01

-0.1 (-1.41%)

AIMT

Aimmune

$23.84

-0.87 (-3.52%)

  • 22

    Feb

DBVT DBV Technologies
$7.01

-0.1 (-1.41%)

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.
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.
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."
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.
AIMT Aimmune
$23.84

-0.87 (-3.52%)

01/18/19
JMPS
01/18/19
NO CHANGE
Target $40
JMPS
Outperform
JMP pushes out launch assumptions for Aimmune's AR101 due to FDA uncertainty
JMP Securities analyst Liisa Bayko noted that the FDA has told Aimmune that it will not begin the review of the BLA for AR101 due to the government shutdown, but also because AR101 is an allergenic product. Beyond the shutdown impact, this action by the FDA, or lack thereof, highlights that AR101 may be exempt from PDUFA, meaning there is no firm commitment to items such as Priority Review, Bayko said. Given this new level of uncertainty, she has pushed back her U.S. launch projection for AR101 to 2020 from late 2019, but since she has also pushed back concurrent launch expenses the delay has no material impact on her valuation, Bayko stated. She keeps an Outperform rating and $40 price target on Aimmune shares.
01/15/19
PIPR
01/15/19
NO CHANGE
Target $60
PIPR
Overweight
Aimmune FDA delay does not change bullish thesis, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond says the FDA review delay for Aimmune Therapeutics' AR101 due to the government shutdown does not change bullish thesis on the shares. In a research note titled "Trump Shutdown Claims its First Biotech Victim (That We Know Of)," Raymond, while admitting that there is clearly no end in sight to the current shutdown, urges investor patience with respect to Aimmune shares as the "fundamental story has not changed." He keeps an Overweight rating on the shares with a $60 price target.
01/03/19
PIPR
01/03/19
NO CHANGE
PIPR
Piper sees Alexion, Biogen as potential targets after Celgene buyout
Piper Jaffray analyst Christopher Raymond remains "bullish on biotech" in the wake the announced acquisition of Celgene (CELG) by Bristol-Myers Squibb (BMY) for $74B in cash and stock, representing a 54% premium from yesterday's close. In a research note titled "Bristol for CELG - In Retrospect, it Makes Perfect Sense," Raymond says the market is likely to ask "who's next?" Among large-caps, Alexion Pharmaceuticals (ALXN) and Biogen (BIIB) would seem to make sense as potential targets, as well as BioMarin (BMRN), Raymond writes. And while any smid cap could likely be seen as a take-out candidate, Aimmune Therapeutics (AIMT), Deciphera Pharmaceuticals (DCPH) and Rigel Pharmaceuticals (RIGL) "in particular could make sense to any strategic buyer," adds the analyst.

TODAY'S FREE FLY STORIES

16:37
02/20/19
02/20
16:37
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16:37
General news
API crude inventories for week of February 15 »

API reports that crude…

TMST

TimkenSteel

$12.34

-0.08 (-0.64%)

16:37
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02/20
16:37
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16:37
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Breaking Hot Stocks news story on TimkenSteel »

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KALU

Kaiser Aluminum

$109.77

2.16 (2.01%)

16:37
02/20/19
02/20
16:37
02/20/19
16:37
Earnings
Kaiser Aluminum sees FY19 low to mid-single digit percent increase in shipments »

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CDE

Coeur Mining

$5.55

0.045 (0.82%)

16:36
02/20/19
02/20
16:36
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16:36
Hot Stocks
Coeur Mining reports Q4 gold production 92.5K oz vs. 118.8K oz last year »

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JKHY

Jack Henry

$132.86

-0.03 (-0.02%)

16:36
02/20/19
02/20
16:36
02/20/19
16:36
Initiation
Jack Henry initiated  »

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TMST

TimkenSteel

$12.34

-0.08 (-0.64%)

16:35
02/20/19
02/20
16:35
02/20/19
16:35
Earnings
TimkenSteel reports Q4 EPS (89c), consensus (6c) »

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KALU

Kaiser Aluminum

$109.77

2.16 (2.01%)

16:35
02/20/19
02/20
16:35
02/20/19
16:35
Earnings
Kaiser Aluminum reports Q4 EPS $1.77, consensus $1.54 »

Reports Q4 revenue $389M,…

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CDE

Coeur Mining

$5.55

0.045 (0.82%)

16:34
02/20/19
02/20
16:34
02/20/19
16:34
Earnings
Coeur Mining reports Q4 EPS 8c, consensus (11c) »

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  • 21

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BSQR

Bsquare Corp

$2.18

(0.00%)

16:34
02/20/19
02/20
16:34
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16:34
Hot Stocks
Bsquare Corp names Ralph Derrickson as President and CEO »

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  • 25

    Feb

SVM

Silvercorp Metals

$2.57

0.05 (1.98%)

16:34
02/20/19
02/20
16:34
02/20/19
16:34
Hot Stocks
Silvercorp says shares 'undervalued,' commences share repurchase program »

Silvercorp Metals…

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SRC

Spirit Realty

$39.34

-0.48 (-1.21%)

16:34
02/20/19
02/20
16:34
02/20/19
16:34
Earnings
Spirit Realty sees FY19 AFFO $3.32-$3.38, consensus $3.39 »

Sees FY19 capital…

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  • 21

    Feb

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SRC

Spirit Realty

$39.34

-0.48 (-1.21%)

16:34
02/20/19
02/20
16:34
02/20/19
16:34
Earnings
Spirit Realty reports Q4 AFFO $1.06, consensus 85c »

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  • 21

    Feb

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    Feb

NDSN

Nordson

$138.81

-0.42 (-0.30%)

16:33
02/20/19
02/20
16:33
02/20/19
16:33
Hot Stocks
Nordson reports Q1 backlog $439M, up 9% from last year. »

CEO Michael Hilton said:…

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  • 21

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    Feb

SNPS

Synopsys

$102.98

1.08 (1.06%)

16:33
02/20/19
02/20
16:33
02/20/19
16:33
Hot Stocks
Breaking Hot Stocks news story on Synopsys »

Synopsys sees FY19…

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    Sep

SNPS

Synopsys

$102.98

1.08 (1.06%)

16:32
02/20/19
02/20
16:32
02/20/19
16:32
Earnings
Synopsys sees FY19 adjusted EPS $4.20-$4.27, consensus $4.24 »

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    Sep

SAM

Boston Beer

$267.95

-0.97 (-0.36%)

16:32
02/20/19
02/20
16:32
02/20/19
16:32
Earnings
Boston Beer sees FY19 EPS $8.00-$9.00, consensus $8.51 »

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  • 20

    Feb

SUI

Sun Communities

$114.00

-0.61 (-0.53%)

16:32
02/20/19
02/20
16:32
02/20/19
16:32
Earnings
Sun Communities reports Q4 FFO $1.03, consensus $1.03 »

Reports Q4 revenue $274M,…

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  • 21

    Feb

TS

Tenaris

$27.38

0.48 (1.78%)

16:32
02/20/19
02/20
16:32
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16:32
Earnings
Tenaris reports Q4 EPS 38c, consensus 43c »

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  • 21

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NDSN

Nordson

$138.81

-0.42 (-0.30%)

16:31
02/20/19
02/20
16:31
02/20/19
16:31
Earnings
Nordson reports Q1 adjusted EPS 92c, consensus $1.12 »

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SNPS

Synopsys

$102.98

1.08 (1.06%)

16:31
02/20/19
02/20
16:31
02/20/19
16:31
Earnings
Synopsys sees Q2 adjusted EPS $1.07-$1.12, consensus $1.05 »

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OMCL

Omnicell

$84.04

1.04 (1.25%)

16:31
02/20/19
02/20
16:31
02/20/19
16:31
Conference/Events
Omnicell management to meet with Benchmark »

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SAM

Boston Beer

$267.95

-0.97 (-0.36%)

16:30
02/20/19
02/20
16:30
02/20/19
16:30
Earnings
Boston Beer reports Q4 EPS $1.86, consensus $1.70 »

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  • 20

    Feb

HCSG

Healthcare Services

$39.96

-0.37 (-0.92%)

16:30
02/20/19
02/20
16:30
02/20/19
16:30
Conference/Events
Healthcare Services management to meet with Benchmark »

Meeting to be held in…

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  • 20

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16:30
02/20/19
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16:30
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16:30
Options
Preliminary option volume of 17.7M today »

Preliminary option volume…

SNPS

Synopsys

$102.98

1.08 (1.06%)

16:29
02/20/19
02/20
16:29
02/20/19
16:29
Earnings
Synopsys reports Q1 EPS $1.08, consensus 97c »

Reports Q1 revenue…

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