MNK - Mallinckrodt Public Limited Company

NYSE - NYSE Delayed Price. Currency in USD
19.20
-1.62 (-7.78%)
At close: 4:01PM EST
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Previous Close20.82
Open20.51
Bid18.90 x 800
Ask22.28 x 2900
Day's Range18.96 - 20.98
52 Week Range11.65 - 36.65
Volume2,217,714
Avg. Volume2,221,645
Market Cap1.6B
Beta (3Y Monthly)1.40
PE Ratio (TTM)0.97
EPS (TTM)19.77
Earnings DateFeb 25, 2019 - Mar 1, 2019
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est31.06
Trade prices are not sourced from all markets
  • Zacks2 days ago

    Mallinckrodt's Roxicodone Reformulation Gets CRL From FDA

    Mallinckrodt (MNK) receives complete response letter from the FDA related to its regulatory application seeking approval for abuse-deterrent reformulation of opioid painkiller, Roxicodone.

  • Benzinga3 days ago

    FDA Snubs Mallinckrodt's Abuse-Deterrent Opioid Reformulation

    Mallinckrodt's generic subsidiary SpecGx LLC said it received a CRL from the FDA pertaining to its NDA for its investigational abuse-deterrent, immediate-release reformulation of its oxycodone hydrochloride tablets. The pipeline candidate is being evaluated to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. A CRL is issued to an applicant if the FDA determines that the application or abbreviated application cannot be approved in its current form.

  • Reuters3 days ago

    FDA declines to approve Mallinckrodt's abuse-deterrent opioid painkiller

    The treatment is a reformulated version of the company's commonly abused painkiller Roxicodone, intended to make the drug less desirable and more difficult to be abused by snorting or injecting. Mallinckrodt's shares fell 4.4 percent to $20.02 in premarket trading on Wednesday. The decision comes after an advisory panel to the FDA voted 10-7 in favor of the drug, saying it should be labeled as abuse deterrent only by the nasal route.

  • The Wall Street Journal3 days ago

    [$$] FDA Doesn't Approve Mallinckrodt's Abuse-Deterrent Roxicodone

    PLC (MNK) on Wednesday said the U.S. Food and Drug Administration indicated it won’t approve the company’s new-drug application for the abuse-deterrent, immediate-release reformulation of the painkiller Roxicodone in its current form. The U.K.-based specialty-pharmaceutical company said its SpecGx LLC unit, which operates its specialty-generics business, received a complete response letter from the FDA that provided guidance on areas of further evaluation needed to resubmit the NDA for further review and potential approval. The agency routinely sends such letters when it determines that a drug application needs more data or research.

  • MarketWatch3 days ago

    Mallinckrodt shares slide 4% premarket after pain treatment approval delayed

    Mallinckrodt plc said Wednesday its SpecGx LLC subsidiary has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its new drug application for Roxicodone, a treatment for pain that is severe enough to require an opioid. The letter provides guidance on areas of further evaluation needed to resubmit the NDA for further review and possible approval. The FDA routinely sends such letters when a drug application is deemed to require further data or research. Roxicodone is an abuse-deterrent, immediate-release formulation that the company is developing as part of an effort to stem the current opioid addiction crisis in the U.S., according to Mallinckrodt. "We are evaluating the FDA's letter and will request a meeting in the coming weeks to discuss it further," Matt Harbaugh, president, specialty generics, said in a statement. Shares fell 4.4% premarket on the news, but are down 7% in 2018, while the S&P 500 has fallen 1.4%.

  • Reuters3 days ago

    FDA declines to approve reformulated Mallinckrodt opioid

    Mallinckrodt Plc said on Wednesday the U.S. Food and Drug Administration declined to approve an abuse-deterrent version of its opioid painkiller Roxicodone. Certain parts of the company's application need further evaluation, Mallinckrodt said, citing the FDA. The treatment is a reformulated version of Mallinckrodt's commonly abused painkiller Roxicodone, intended to make the drug less desirable and more difficult to be abused by snorting or injecting.

  • PR Newswire3 days ago

    Mallinckrodt's SpecGx LLC Receives FDA Complete Response Letter for Abuse-Deterrent, Immediate-Release Reformulation of Roxicodone® (Oxycodone Hydrochloride)

    STAINES-UPON-THAMES, United Kingdom, Dec. 12, 2018 /PRNewswire/ -- SpecGx LLC, a subsidiary of Mallinckrodt plc (MNK) that operates its Specialty Generics business, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets, USP for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. In the letter, the Agency provided guidance regarding areas of further evaluation necessary to resubmit the NDA for further review and potential approval of the drug, which was designed with properties to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application MNK-812.

  • Mallinckrodt (MNK) to Separate Generics & Branded Businesses
    Zacks8 days ago

    Mallinckrodt (MNK) to Separate Generics & Branded Businesses

    Mallinckrodt (MNK) announces plans to split its generic and branded businesses into two different companies.

  • Mallinckrodt company that remains in St. Louis faces big threats
    American City Business Journals8 days ago

    Mallinckrodt company that remains in St. Louis faces big threats

    On Thursday it was announced that the pharmaceutical company Mallinckrodt plans to spin off its generic drug business in 2019, leaving questions how that would affect its location in St. Louis.

  • Investors Hope Cleaving of Mallinckrodt Provides Meaty Returns
    GuruFocus.com8 days ago

    Investors Hope Cleaving of Mallinckrodt Provides Meaty Returns

    Mallinckrodt PLC (MKN) is splitting up. At about $22, the company's shares are where they were 12 months hence and just a fraction of the $130 they traded for just two-and-a-half years earlier. Warning! GuruFocus has detected 4 Warning Signs with T. Click here to check it out.

  • Moody's9 days ago

    Mallinckrodt plc -- Moody's: Mallinckrodt's proposed specialty generics spin-off is credit negative

    Moody's Investors Service commented that Mallinckrodt International Finance SA's announcement that it plans to spin off its specialty generics business in 2019 into an independent publicly traded company is credit negative. There is no impact to Mallinckrodt's ratings at this time, including the Ba3 Corporate Family Rating. For additonal information please refer to Moody's Issuer Comment on Mallinckrodt International Finance SA available on www.moodys.com.

  • Mallinckrodt to spin off generic drugs business; specialty drugs to be based in New Jersey
    American City Business Journals9 days ago

    Mallinckrodt to spin off generic drugs business; specialty drugs to be based in New Jersey

    St. Louis-area pharmaceutical company, Mallinckrodt, announced that it plans to spin off its generic drug business in 2019.

  • Reuters9 days ago

    Mallinckrodt to spin off generics business, but to keep options open

    Mallinckrodt Plc plans to spin off its specialty generics business to shareholders by the second half of 2019, but said it was still open to a sale of the unit. Mallinckrodt's shares fell 7.5 percent to $21.41 on Thursday morning. The generics business, which generated revenue of $839.5 million in fiscal 2017, largely makes opioid drugs and has come under pressure as more doctors in the United States shy away from prescribing the addictive medicines that had claimed nearly 50,000 lives last year.

  • MarketWatch9 days ago

    Shares of Mallinckrodt Pharmaceuticals up 0.5% after company announces generics business spin-off

    Shares of Mallinckrodt PLC were up 0.4% in premarket trade Thursday after the company announced it was planning to spin off its generics business to its shareholders. The spin-off, which is projected to be completed in the second half of 2019, will result in two publicly traded companies, Mallinckrodt said: A generics-focused company that will assume the Mallinkrodt name and ticker, and a second company that will focus on specialty pharmaceutical brands and will be renamed at a later date. The newly spun-off company will be led by Mark Trudeau, Mallinckrodt's current president and CEO. The remaining business will be helmed by current CFO Matthew Harbaugh. Shares of Mallinkrodt have gained 2.6% in the year to date, while the S&P 500 has gained 1%.

  • PR Newswire10 days ago

    Mallinckrodt Plans Spin-Off of Specialty Generics Business to Shareholders

    STAINES-UPON-THAMES, United Kingdom, Dec. 6, 2018 /PRNewswire/ -- Mallinckrodt plc (MNK), a leading global specialty pharmaceutical company, today announced plans to spin off a new company consisting of Mallinckrodt's Specialty Generics/Active Pharmaceutical Ingredients (Specialty Generics) business and AMITIZA® (lubiprostone) to Mallinckrodt shareholders, subject to final Board approval.

  • Is Mallinckrodt Public Limited Company (NYSE:MNK) A Volatile Stock?
    Simply Wall St.11 days ago

    Is Mallinckrodt Public Limited Company (NYSE:MNK) A Volatile Stock?

    If you’re interested in Mallinckrodt Public Limited Company (NYSE:MNK), then you might want to consider its beta (a measure of share price volatility) in order to understand how the stock Read More...

  • 5 Top Stock Trades for Tuesday: GE, GM and Cyber Monday
    InvestorPlace19 days ago

    5 Top Stock Trades for Tuesday: GE, GM and Cyber Monday

    Stocks are roaring higher on Cyber Monday, as strong online sales are buoying bulls’ hope for a year-end rally. Let’s take a look at our top stock trades for Tuesday. The leader in e-commerce continues to grow its share of the pie, as online sales continue to maintain strong momentum.

  • Why Mallinckrodt Stock Sank Today
    Motley Fool19 days ago

    Why Mallinckrodt Stock Sank Today

    A negative tweet from a noted short-seller caused the drug stock to tumble.

  • ACCESSWIRE19 days ago

    Mallinckrodt plc (MNK) Investigated by Block & Leviton LLP For Violations of Federal Securities Laws

    BOSTON, MA / ACCESSWIRE / November 26, 2018 / Block & Leviton LLP ( www.blockesq.com ), a securities litigation firm representing investors nationwide, is investigating whether Mallinckrodt plc ("Mallinckrodt" ...

  • Barrons.com26 days ago

    Mallinckrodt Stock Can Rally Another 27%, Says Analyst

    Canaccord’s Dewey Steadman upgraded the drug maker to Buy from Hold and raised the price target to $40 from $34.

  • Benzinga26 days ago

    Canaccord Turns Bullish On Mallinckrodt: 4 Reasons Why

    Mallinckrodt continues to execute on its core business and could potentially move its Acthar franchise to stability or even growth, Steadman said in the Monday upgrade note. ◘ Challenges to Inomax — the company's treatment option for hypoxic respiratory failure in term and near-term infants — from a potential launch of competing products by Praxair or AIT Therapeutics Inc (OTC: AITB) do not pose a threat of erosion of the entire franchise, Steadman said.

  • How Is Salix Pharmaceuticals Positioned in November?
    Market Realist26 days ago

    How Is Salix Pharmaceuticals Positioned in November?

    Bausch Health’s (BHC) wholly owned subsidiary Salix Pharmaceuticals generated revenues of $460.0 million in the third quarter compared to $452.0 million in the third quarter of 2017, reflecting ~2% YoY growth. Xifaxan and Relistor primarily contributed to the revenue growth of Salix Pharmaceuticals in the third quarter. In the third quarter, Xifaxan and Relistor witnessed ~11% and 88% YoY organic revenue growth.

  • Benzinga29 days ago

    The Daily Biotech Pulse: Mallinckrodt FDA Verdict, European Cheer For Bristol-Myers Squibb, Morphosys Clinches Licensing Deal

    Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peak (Biotech stocks hitting 52-week highs on Nov. 15) Vapotherm, Inc. (NYSE: VAPO ) Down In The Dumps (Biotech ...

  • Mallinckrodt Gets FDA Committee Vote for Abuse-Deterrent Drug
    Zackslast month

    Mallinckrodt Gets FDA Committee Vote for Abuse-Deterrent Drug

    The FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee vote for Mallinckrodt (MNK) abuse-deterrent drug.