Mallinckrodt PLC(MNK)- NYSE
  • Fri, Sep. 23, 9:16 AM
    • In an Inter Partes Review, the USPTO's Patent Trial and Appeals Board (PTAB) upholds five Mallinckrodt (NYSE:MNK) patents covering INOMAX (nitric oxide) gas for inhalation. The patents, valid until 2031, were challenged by Praxair Distribution (NYSE:PX).
    • INOMAX is approved in the U.S. to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation in term and near-term (at least 34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension in conjunction with ventilator support and other agents.
    | Fri, Sep. 23, 9:16 AM
  • Thu, Aug. 25, 9:14 AM
    • The FDA designates Mallinckrodt's (NYSE:MNK) Synacthen (tetracosactide) depot formulation (long acting) for Fast Track review for the treatment of Duchenne muscular dystrophy (DMD). A Phase 1 study is underway.
    • Synacthen, a 24-amino acid melanocortin receptor agonist, is a synthetic version of the natural hormone ACTH (adrenocorticotrophic hormone). It is currently approved ex-U.S. to test if the adrenal glands are working properly and to treat adrenocortical insufficiency.
    • DMD is an inherited disorder caused by the absence of a protein called dystrophin. It is characterized by progressive muscle degeneration and weakness.
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
    • DMD-related tickers: (NASDAQ:SRPT)(NASDAQ:BMRN)(NASDAQ:SMMT)(NASDAQ:PTCT)(NYSE:PFE)(OTCQB:MRNA)(NASDAQ:CATB)
    | Thu, Aug. 25, 9:14 AM | 10 Comments
  • Wed, Aug. 24, 8:38 AM
    • Mallinckrodt (NYSE:MNK) inks a deal to sell its Nuclear Imaging business to IBA Molecular for ~$690M, consisting of an upfront payment of $574M, contingencies of $77M and the assumption of $39M in long-term obligations.
    • The unit includes a portfolio of diagnostic imaging products including the medical isotope molybdenum-99, the source of technetium-99m, used in ~80% of nuclear medicine procedures worldwide. About 2/3 of the total business is in the U.S.
    • The transaction, expected to close in H1, 2017, includes 800 employees and two manufacturing facilities in Missouri and the Netherlands.
    | Wed, Aug. 24, 8:38 AM
  • Fri, Aug. 19, 8:01 AM
    • Arrowhead Pharmaceuticals (NASDAQ:ARWR) initiated with Buy rating and $15 (112% upside) price target by Cantor Fitzgerald.
    • Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Buy rating and $15 (92% upside) price target by H.C. Wainwright.
    • Mediwound Ltd. (NASDAQ:MDWD) initiated with Outperform rating and $14 (75% upside) price target by Wells Fargo.
    • SCYNEXIS (NASDAQ:SCYX) initiated with Buy rating and $15 (436% upside) price target by Guggenheim Securities.
    • Patheon NV (Pending:PTHN) initiated with Neutral rating and $30 (7% upside) price target by Credit Suisse. Initiated with Buy rating and $32 (14% upside) price target by Jefferies. Initiated with Overweight rating and $31 (11% upside) price target by Morgan Stanley.
    • GlycoMimetics (NASDAQ:GLYC) initiated with Outperform rating by Cowen and Company. Initiated with Outperform rating and $32.50 (306% upside) price target by Raymond James.
    • Audentes Therapeutics (Pending:BOLD) initiated with an Outperform rating by Cowen and Company. Initiated with Outperform rating and $20 (33% upside) price target by Wedbush.
    • Mallinckrodt (NYSE:MNK) initiated with Buy rating and $95 (19% upside) price target by Stifel Nicolaus.
    • TESARO (NASDAQ:TSRO) initiated with Outperform rating and $122 (28% upside) price target by RBC Capital.
    | Fri, Aug. 19, 8:01 AM | 1 Comment
  • Wed, Aug. 10, 6:54 PM
    • Mallinckrodt plc (NYSE:MNK) acquires privately held Stratatech for an undisclosed sum. The Madison, WI-based regenerative medicine firm develops proprietary skin substitute products.
    • Its lead pipeline candidate is Phase 3-stage StrataGraft, an "off-the-shelf" skin substitute for the treatment of severe burns.
    • The transaction should close later this year. According to the company, it is unable to provide guidance on the impact of the deal to EPS due to the difficulty in forecasting the timing or amount of items that would impact GAAP earnings.
    | Wed, Aug. 10, 6:54 PM | 1 Comment
  • Tue, Aug. 2, 9:17 AM
    | Tue, Aug. 2, 9:17 AM | 3 Comments
  • Tue, Aug. 2, 6:35 AM
    • Mallinckrodt (MNK) FQ3 results: Revenues: $970.6M (+10.6%); Operating Income: $202.9M (+59.6%); Net Income: $195.7M (+252.0%); EPS: $1.79 (+280.9%); Non-GAAP EPS: $2.20 (+8.9%); Quick Assets: $521.9M (+42.6%); CF Ops: $994.4M (+77.8%).
    • 2016 Guidance: Adjusted EPS: $8.50 - 8.80 from $8.15 - 8.50.
    | Tue, Aug. 2, 6:35 AM
  • Tue, Aug. 2, 6:04 AM
    • Mallinckrodt (NYSE:MNK): FQ3 EPS of $2.20 beats by $0.19.
    • Revenue of $970.6M (+10.6% Y/Y) beats by $48.78M.
    • Press Release
    | Tue, Aug. 2, 6:04 AM | 6 Comments
  • Mon, Aug. 1, 5:30 PM
  • Fri, Jul. 1, 10:08 AM
    • Invitae (NYSE:NVTA) initiated with Hold rating with an $8.50 (18% upside) price target by Benchmark.
    • Jazz Pharmaceuticals (NASDAQ:JAZZ) initiated with Outperform rating and $190 (33% upside) price target by BMO.
    • Pacira Pharmaceuticals (NASDAQ:PCRX) initiated with Underperform rating and $36 (4% upside) price target by BMO.
    • Mallinckrodt (NYSE:MNK) initiated with Outperform rating and $84 (35% upside) price target by BMO.
    • Horizon Pharma plc (NASDAQ:HZNP) initiated with Outperform rating and $29 (71% upside) price target by BMO.
    • Regeneron Pharmaceuticals (NASDAQ:REGN) initiated with an Outperform rating and $400 (13% upside) price target by Bernstein.
    • Biogen (NASDAQ:BIIB) initiated with an Outperform rating and $282 (15% upside) price target by Bernstein.
    • Amgen (NASDAQ:AMGN) initiated with Market Perform rating and $161 (5% upside) price target by Bernstein.
    • Lannett Company (NYSE:LCI) initiated with Hold rating and $26 (5% upside) price target by Deutsche Bank.
    • OpGen (NASDAQ:OPGN) initiated with Buy rating and $2.50 (66% upside) price target by Rodman & Renshaw.
    • Valeant Pharmaceuticals (NYSE:VRX) initiated with Market Perform rating and $26 (22% upside) price target by BMO.
    • Neurocrine Biosciences (NASDAQ:NBIX) initiated with Outperform rating and $80 (75% upside) price target by H.C. Wainwright.
    • Healthstream (NASDAQ:HSTM) initiated with Outperform rating and $30 (12% upside) price target by Barrington Research.
    • Neurometrix (NASDAQ:NURO) initiated with Buy rating and $4.50 (165% upside) price target by Rodman & Renshaw.
    • Vascular Biogenics (NASDAQ:VBLT) initiated with Buy rating and $11 (139% upside) price target by H.C. Wainwright.
    | Fri, Jul. 1, 10:08 AM | 7 Comments
  • Fri, Jun. 10, 7:19 AM
    • Boston Scientific (NYSE:BSX) initiated with Buy rating and $26 (13% upside) price target by Guggenheim Securities.
    • Zimmer Biomet Holdings (NYSE:ZBH) initiated with Neutral rating and $140 (18% upside) price target by Guggenheim Securities.
    • Edwards Lifesciences (NYSE:EW) initiated with Neutral rating and $120 (18% upside) price target by Guggenheim Securities.
    • Oncobiologics (Pending:ONS) initiated with Buy rating and $15 (218% upside) price target by Cantor Fitzgerald.
    • Walgreens Boots Alliance (NASDAQ:WBA) reinstated with Buy rating and $95 (20% upside) price target by Bank of America.
    • Goldman Sachs initiates coverage of specialty pharma with a Neutral rating: Buy: Jazz Pharma (NASDAQ:JAZZ) - $196 (26% upside) price target, Horizon Pharma (NASDAQ:HZNP) - $24 (30% upside) price target; Neutral: Endo International (NASDAQ:ENDP) - $20 (11% upside) price target, Mallinckrodt (NYSE:MNK) - $73 (17% upside) price target, Momenta Pharmaceuticals (NASDAQ:MNTA) - $14 (19% upside) price target; Concordia Healthcare (NASDAQ:CXRX) - $32 (31% upside) price target; Sell: Impax Laboratories (NASDAQ:IPXL) - $33 (2% downside risk) price target.
    • Biocept (NASDAQ:BIOC) initiated with Buy rating and $1.20 (71% upside) price target by Roth Capital.
    • Seres Therapeutics (NASDAQ:MCRB) initiated with Outperform rating and $40 (22% upside) price target by Cowen & Company.
    • Omeros (NASDAQ:OMER) initiated with Buy rating and $21 (94% upside) price target by Cantor Fitzgerald.
    • Glaukos (NYSE:GKOS) initiated with Buy rating and $35 (30% upside) price target by Cantor Fitzgerald.
    • Shire plc (NASDAQ:SHPG) initiated with Overweight rating and GBX5,600 (34% upside) price target by Morgan Stanley.
    | Fri, Jun. 10, 7:19 AM
  • Wed, May 18, 8:43 PM
    • With the aim of better aligning its financial reporting with its customers and industry peers, Mallinckrodt (NYSE:MNK) changes its fiscal year end to the last Friday in December from the last Friday in September. There will be a transition period from October 1 to December 30, 2016, the results from which will be reported in February 2017.
    | Wed, May 18, 8:43 PM | 2 Comments
  • Tue, May 3, 9:15 AM
    | Tue, May 3, 9:15 AM
  • Tue, May 3, 8:35 AM
    • Mallinckrodt (MNK) FQ2 results: Revenues: $918M (+12.1%); R&D Expense: $58.6M (+1.0%); SG&A: $231.2M (-25.0%); Operating Income: $164.4M (+75.1%); Net Income: $120.3M (+60.0%); EPS: $1.07 (+67.2%); Non-GAAP EPS: $2.01 (+18.2%); Quick Assets: $341.4M (-6.7%); CF Ops: $540.1M (+47.8%).
    • 2016 Guidance: Adjusted EPS: $8.15 - 8.50 from $7.85 - 8.30.
    | Tue, May 3, 8:35 AM | 5 Comments
  • Tue, May 3, 6:03 AM
    • Mallinckrodt (NYSE:MNK): FQ2 EPS of $2.01 beats by $0.29.
    • Revenue of $918M (+12.1% Y/Y) beats by $46.6M.
    • Press Release
    • Shares are up 5% premarket on light volume.
    | Tue, May 3, 6:03 AM
  • Mon, May 2, 5:30 PM