|Bid||18.90 x 800|
|Ask||22.28 x 2900|
|Day's Range||18.96 - 20.98|
|52 Week Range||11.65 - 36.65|
|Beta (3Y Monthly)||1.40|
|PE Ratio (TTM)||0.97|
|Earnings Date||Feb 25, 2019 - Mar 1, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||31.06|
Mallinckrodt (MNK) receives complete response letter from the FDA related to its regulatory application seeking approval for abuse-deterrent reformulation of opioid painkiller, Roxicodone.
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.
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.
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.
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%.
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.
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.
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.
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'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.
St. Louis-area pharmaceutical company, Mallinckrodt, announced that it plans to spin off its generic drug business in 2019.
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.
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%.
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.
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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.