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MNK

Mallinckrodt

$30.92

-0.17 (-0.55%)

17:11
11/14/18
11/14
17:11
11/14/18
17:11

Mallinckrodt reports on FDA advisory committee findings on Roxicodone

SpecGx LLC, a subsidiary of Mallinckrodt plc (MNK) announced that, in a joint meeting, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 7 to approve the SpecGx investigative abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Additionally, the Committees voted 12 to 5 that the drug should be labeled as an abuse-deterrent product by the nasal route of abuse. The Committees also voted 10 to 7 that the drug should not be labeled as an abuse-deterrent product by the intravenous route of abuse. SpecGx is advancing this reformulation of Roxicodone with properties designed to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application MNK-812. The company has been a leader for a number of years in delivering important solutions, including development of this technology, to reduce opioid misuse, abuse and diversion.

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MNK Mallinckrodt
$30.92

-0.17 (-0.55%)

11/13/18
MZHO
11/13/18
NO CHANGE
Target $29
MZHO
Neutral
Mallinckrodt price target raised to $29 from $27 at Mizuho
Mizuho analyst Irina Koffler raised her price target for Mallinckrodt to $29 citing improved durability for Acthar and INOmax. The analyst says the tone at Mallinckrodt's marketing event last week on Acthar was "incrementally upbeat." However, she reiterates a Neutral rating on the shares.
11/06/18
WELS
11/06/18
NO CHANGE
Target $27
WELS
Market Perform
Mallinckrodt growth appears challenged in 2019, says Wells Fargo
Wells Fargo analyst David Maris noted that Mallinckrodt reported Q3 earnings that beat his and consensus estimates due to higher revenues and lower operating spending, but he is still modeling a 5% decline next year for the company's largest product, Acthar. Noting that view of Acthar, as well as considering share loss for Inomax and the company's leverage, Maris said he sees the shares as fairly valued and keeps a Market Perform rating on Mallinckrodt. Maris raised his price target on Mallinckrodt shares to $27 from $24 as he raised his 2018 EPS estimate to $7.13 from $6.82.
10/08/18
10/08/18
NO CHANGE
Target $24

Market Perform
Wells cuts Mallinckrodt target to $24 after confirming Praxair generic approval
Wells Fargo analyst David Maris says he confirmed this morning with Praxair (PX) that the device associated with generic Inomax has been approved. Praxair would not provide any additional details around the launch timing or pricing plans, Maris tells investors in a research note. The analyst lowered his price target for Mallinckrodt (MNK) shares to $24 from $30 after reducing his estimates to account for the generic taking approximately 20% share over the next several years. He models Mallinckrodt's Inomax going from a 5% grower to a slight decline. Maris admits, however, that there are "strong reasons" to think Inomax has a more defensible position than losing 20% share, such as a loyal installed base and a high service level. Nonetheless, he believes uncertainty around the generic device approval warrant a reduced outlook. The analyst keeps a Market Perform rating on Mallinckrodt. The stock in morning trading is down 5c to $25.83.
10/05/18
JEFF
10/05/18
NO CHANGE
Target $35
JEFF
Buy
Mallinckrodt 17% selloff yesterday 'well overdone,' says Jefferies
Jefferies analyst Anthony Petrone views the 17% selloff yesterday in shares of Mallinckrodt (MNK) as "well overdone." The pullback on Praxair's (PX) abbreviated new drug application clearance of Noxivent effectively prices in a $130M revenue shortfall on Mallinckrodt's INOmax in the near term, Petrone tells investors in a research note. Conversely, the analyst expects a more gradual erosion given the ongoing patent appeal process, potential label extension on INOmax, and the need for infrastructure investment on the part of Praxair. He keeps a Buy rating on Mallinckrodt with a $35 price target.

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MSGN

MSG Networks

$14.78

-2.07 (-12.28%)

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TGT

Target

$103.11

17.54 (20.50%)

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MSG

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LOW

Lowe's

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COO

Cooper Companies

$332.66

0.39 (0.12%)

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$0.00

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COO

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CERN

Cerner

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$103.11

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SLM

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ORBC

Orbcomm

$4.84

-0.055 (-1.12%)

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CLSD

Clearside Biomedical

$1.27

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RCKT

Rocket Pharmaceuticals

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HIW

Highwoods Properties

$43.92

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MYGN

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KSHB

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RTRX

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SRAX

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