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MNK

Mallinckrodt

09:43
10/17/16
10/17
09:43
10/17/16
09:43

FDA proposes to withdraw approval of ANDA for methylphenidate HCI ER

The FDA's Center for Drug Evaluation and Research is proposing to withdraw approval of an abbreviated new drug application, or ANDA, for methylphenidate hydrochloride extended-release tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal, according to a document scheduled to be published in the Federal Register on Oct. 18. Mallinckrodt Pharmaceuticals may submit a request for a hearing, the document states. Reference Link

  • 29

    Nov

  • 14

    Dec

MNK Mallinckrodt

08/18/16
08/18/16
NO CHANGE

Mallinckrodt building new campus for Specialty Brands business in New Jersey
Mallinckrodt will build out a new campus for its Specialty Brands organizations in the Somerset Financial Center in Bedminster. Mallinckrodt will invest greater than $80M in New Jersey, and anticipates approximately 400 employees will occupy the new space in 1Q17. The company is also continuing its investment in St. Louis, Mo., having recently begun the next phase of construction at its downtown St. Louis manufacturing facility.
08/24/16
PIPR
08/24/16
NO CHANGE
Target $112
PIPR
Overweight
Mallinckrodt price target raised to $112 from $103 at Piper Jaffray
Piper Jaffray analyst David Amsellem said his talks with Mallinckrodt management indicate that the company's contracting activity is providing greater standardization of Acthar coverage and generally making the process of getting an Acthar prescription filled more predictable. In turn, this should make it more likely that physicians and practices will more consistently prescribe the drug, Amsellem tells investors. Paired with additional clinical outcomes data, Amsellem sees high visibility for relatively strong volume growth over the long-term and raised his price target on Mallinckrodt shares to $112 from $103 while keeping an Overweight rating on the stock.
08/26/16
UBSW
08/26/16
NO CHANGE
Target $92
UBSW
Buy
Skepticism on Acthar growth already priced into Mallinckrodt shares, says UBS
UBS analyst Marc Goodman said his investment thesis on Mallinckrodt remains unchanged, as he still sees an attractive valuation, has expectations its generics business will stabilize and believes that skepticism surrounding Acthar's growth is already priced into the stock. Goodman reiterated his Buy rating and $92 price target on Mallinckrodt shares.
09/21/16
MSCO
09/21/16
NO CHANGE
MSCO
Mallinckrodt's Ikaria acquisition underappreciated, says Morgan Stanley
Morgan Stanley analyst David Risinger said since the closing of the Ikaria acquisition, Mallinckrodt has quietly grown to be approximately 15% of 2017 estimates revenues and approximately 25% of 2017 estimated operating income. Given Ikaria's strong growth trends, Risinger estimates its valuation to be in the range of $3.9B-$4.3B, excluding Terlipressin pipeline asset, 78% more at the midpoint than Mallinckrodt's $2.3B purchase price.

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MRUS

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ANY

Sphere 3D

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