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MNK

Mallinckrodt

$21.90

0.1 (0.46%)

07:00
02/20/19
02/20
07:00
02/20/19
07:00

Mallinckrodt elects to discontinue further enrollment in Uvadex, Therakos trial

Mallinckrodt announced interim analysis results of its company-sponsored, Phase 3, single-arm, open-label, multi-center study assessing the efficacy of treating steroid-refractory, acute Graft-versus-Host Disease, or aGvHD, pediatric patients with Uvadex Sterile Solution in conjunction with the Therakos Cellex Photopheresis system. Given the overall response rate exceeded the specified target at the study midpoint, the company is electing not to proceed with further enrollment of additional patients in the clinical trial. Uvadex solution is FDA-approved for extracorporeal administration with the Therakos Uvar XTS or Cellex Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma, or CTCL, that is unresponsive to other forms of treatment. The planned interim analysis occurred at the midway point of enrollment when pediatric patients reached four weeks of therapy to assess response rates. The analysis found an overall response rate of 74%. The company also performed an ad hoc 12-week analysis showing an overall response rate of 48%. The study protocol allows for discontinuation of the study if the treatment overall response rate at the four-week interim analysis is at least 48%. Eleven serious adverse events were reported, leading to two subject withdrawals and two deaths; none were considered related to the Uvadex photopheresis therapy. The safety and effectiveness of Therakos Cellex Photopheresis System for use in treating pediatric patients with steroid-refractory aGvHD has not been evaluated by the FDA or any international regulatory body.

  • 26

    Feb

MNK Mallinckrodt
$21.90

0.1 (0.46%)

12/07/18
WELS
12/07/18
NO CHANGE
Target $27
WELS
Market Perform
Mallinckrodt investor worries 'worthy of concern,' says Wells Fargo
Wells Fargo analyst David Maris attrubites the 7% selloff yesterday in shares of Mallinckrodt to investors recognizing that the spin-off process could take at least six months and the proceeds previously expected from a sale will now come in the form of levering the spin with debt. Furthering pressing the shares could the realiztioin that the company's opioid and environmental liabilities may not have been fully appreciated, Maris tells investors in a research note partially titled "Questions, But A Reasonable Alternative." The fact that the generics business now has to be consolidated after being reported as a discontinued operation, only to be taken out again when the spin is completed is also challenging for some investors, Maris writes. The analyst, while admitting Mallinckrodt's current cash flow is "very appealing," acknowledges that the re-consolidation and then spin of the generics unit, pending competition of Inomax in 2019, and investor worries about Acthar is "worthy of concern." He maintains a Market Perform rating on Mallinckrodt shares with a $27 price target.
12/17/18
MZHO
12/17/18
NO CHANGE
Target $22
MZHO
Neutral
Mallinckrodt price target lowered to $22 from $29 at Mizuho
Mizuho analyst Irina Koffler lowered her price target for Mallinckrodt to $22 while presenting an initial view of how to value the two separate companies. The analyst reduced estimates for Acthar and took a more "conservative stance" on Amitiza's long-term outlook. She also penalized the spin company $2 per share for estimated opioid liability. Koffler ascribes $16 per share to the branded business and $6 to the spin company. She reiterates a Neutral rating on Mallinckrodt.
12/31/18
RILY
12/31/18
NO CHANGE
Target $21
RILY
Neutral
Mallinckrodt price target lowered to $21 from $37 at B. Riley FBR
B. Riley FBR analyst David Buck lowered his price target for Mallinckrodt to $21 after the company earlier this month announced plans to spin off a new company consisting of its specialty generics business and Amitiza to shareholders. The analyst keeps a Neutral rating on the shares.
01/15/19
WELS
01/15/19
NO CHANGE
WELS
House probe brings 'headline risk' for Mallinckrodt, Teva, says Wells Fargo
Representative Elijah Cummings, Chairman of the U.S. House of Representatives Committee on Oversight and Reform, announced the launch of an investigation yesterday into drug pricing practices, Wells Fargo analyst David Maris tells investors in a research note titled "And So It Begins..." Yesterday's news will be the first of many investigations, Maris writes. He thinks the industry and stock valuation multiples "are vulnerable given intense focus and investigation by the House." Of the names he covers, Mallinckrodt (MNK) and Teva (TEVA) were named in the investigation. Near-term, the investigation creates "some additional headline risk" on the sector and the companies, particularly for Mallinckrodt, which has previously been under scrutiny for Acthar, says Maris.

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SMTX

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ACRGF

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HEXO

HEXO Corp

$3.94

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CURLF

Curaleaf Holdings

$0.00

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CHNR

China Natural Resources

$2.53

0.13 (5.42%)

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KEY

KeyCorp

$18.04

-0.18 (-0.99%)

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ASA

ASA Limited

$12.56

0.25 (2.03%)

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NDLS

Noodles & Company

$5.92

-0.05 (-0.84%)

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TLRY

Tilray

$29.91

-0.59 (-1.93%)

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MSFT

Microsoft

$141.08

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PM

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GE

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MLHR

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PGR

Progressive

$75.77

0.57 (0.76%)

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CGC

Canopy Growth

$26.33

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CRON

Cronos Group

$10.23

-0.725 (-6.62%)

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ACB

Aurora Cannabis

$5.16

-0.11 (-2.09%)

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AWK

American Water

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NXST

Nexstar

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STZ

Constellation Brands

$207.45

-0.06 (-0.03%)

, STZ.B

Constellation Brands; also tag STZ

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STZ.B

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