MNK - Mallinckrodt plc

NYSE - NYSE Delayed Price. Currency in USD
2.2300
-0.0900 (-3.88%)
At close: 4:02PM EDT
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Previous Close2.3200
Open2.2100
Bid2.1800 x 3000
Ask2.2400 x 1800
Day's Range2.0700 - 2.2550
52 Week Range1.0000 - 23.9000
Volume2,175,079
Avg. Volume8,844,335
Market Cap187.782M
Beta (5Y Monthly)2.45
PE Ratio (TTM)N/A
EPS (TTM)-11.8770
Earnings DateMay 04, 2020 - May 10, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est3.23
  • Barrons.com

    The Coronavirus Outbreak Has Derailed Settlements in the Opioid Litigation

    The sprawling litigation brought by state and local governments seeking to hold drugmakers and distributors responsible for the opioid crisis was supposed to be mostly settled by now. Then Covid-19 happened.

  • Mallinckrodt Completes NDA Submission for Kidney Failure Drug
    Zacks

    Mallinckrodt Completes NDA Submission for Kidney Failure Drug

    Mallinckrodt (MNK) nears approval of its kidney failure candidate, terlipressin, with the completion of rolling submission of an NDA for the same.

  • Mallinckrodt Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)
    PR Newswire

    Mallinckrodt Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)

    Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1 (HRS-1). The company previously announced the rolling submission, which it initiated in February.

  • Barrons.com

    Drugmaker Mallinckrodt Gives Creditors Deadline Today on Debt Refinance, Opioid Division Bankruptcy

    The deadline follows a U.S. court ruling on Friday that rejected Mallinckrodt’s challenge to Medicaid’s demand for a huge refund on government payments for the company’s drug, Acthar Gel. On Monday, Mallinckrodt said it plans to appeal the ruling.

  • MarketWatch

    Mallinckrodt's stock plunges on court decision regarding Acthar Gel rebates

    Shares of Mallinckrodt PLC tumbled 21% in premarket trading Monday, after the drug maker said it would pay about $650 million for the period from Jan. 1, 2013 to the present as a result of a U.S. District Court decision on Acthar Gel rebates. The company confirmed the court upheld the Centers for Medicare and Medicaid Services' (CMS) decision to reverse its determination of the base date average manufacturer price (AMP) used to calculate Acthar Gel rebates. Mallinckrodt estimates that change to the Medicaid rebate calculation will lower Acthar Gel sales by about $90 million to $100 million. "This is clearly a disappointing ruling by the District Court," said Chief Legal Officer Mark Casey. "This is clearly a disappointing ruling by the District Court." The stock has lost 71.7% over the past 12 months through Friday, while the S&P 500 has slipped 4.0%.

  • Mallinckrodt Confirms Court Decision in Lawsuit Against U.S. Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) and Provides Update Related to Global Opioid Settlement and Present Financing Activities
    PR Newswire

    Mallinckrodt Confirms Court Decision in Lawsuit Against U.S. Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) and Provides Update Related to Global Opioid Settlement and Present Financing Activities

    Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today confirmed that its subsidiary, Mallinckrodt ARD LLC, received a decision from the U.S. District Court for the District of Columbia in its suit against HHS and CMS (or the Agency) regarding the company's calculation of Medicaid drug rebates for Acthar® Gel (repository corticotropin injection). The District Court upheld CMS' decision to reverse its previous determination of the base date average manufacturer price (AMP) used to calculate Acthar Gel rebates.

  • Coronavirus Drug Development Efforts Pick Up Amid Sell-Off
    Zacks

    Coronavirus Drug Development Efforts Pick Up Amid Sell-Off

    Several drug/biotech companies are working on making new antibodies, drugs and vaccines to prevent and treat COVID-19.

  • Mallinckrodt Up on New York's Support for Opioid Settlement
    Zacks

    Mallinckrodt Up on New York's Support for Opioid Settlement

    Mallinckrodt's (MNK) proposed global opioid settlement receives support from New York State Attorney General, taking the total support count to 48 states and territories.

  • The Daily Biotech Pulse: AstraZeneca Faces Setback In Ovarian Cancer Study, Mallinckrodt To Explore COVID-19 Treatment, Imara IPO
    Benzinga

    The Daily Biotech Pulse: AstraZeneca Faces Setback In Ovarian Cancer Study, Mallinckrodt To Explore COVID-19 Treatment, Imara IPO

    Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week highs on March 11) * Bicycle Therapeutics PLC (NASDAQ: BCYC) (reacted to its fourth-quarter results) * Centogene NV (NASDAQ: CNTG) * Tiziana Life Sciences PLC (NASDAQ: TLSA) ( announced plans to develop its investigational monoclonal antibody for treating COVID-19)Down In The Dumps (Biotech Stocks Hitting 52-week lows on March 11) * Accelerate Diagnostics Inc (NASDAQ: AXDX) * Achieve Life Sciences Inc (NASDAQ: ACHV) * Acorda Therapeutics Inc (NASDAQ: ACOR) * Adamas Pharmaceuticals Inc (NASDAQ: ADMS) * Adaptive Biotechnologies Corp (NASDAQ: ADPT) * Aeglea Bio Therapeutics Inc (NASDAQ: AGLE) * Aerie Pharmaceuticals Inc (NASDAQ: AERI) * Affimed NV (NASDAQ: AFMD) * Aileron Therapeutics Inc (NASDAQ: ALRN) * Akari Therapeutics PLC (NASDAQ: AKTX) * Akcea Therapeutics Inc (NASDAQ: AKCA) * Akorn, Inc. (NASDAQ: AKRX) * Aldeyra Therapeutics Inc (NASDAQ: ALDX) * Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) * Alkermes Plc (NASDAQ: ALKS) * AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) * Amarin Corporation plc (NASDAQ: AMRN) * ANCHIANO THERAP/S ADR (NASDAQ: ANCN) * AngioDynamics, Inc. (NASDAQ: ANGO) * ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP) * Anixa Biosciences Inc (NASDAQ: ANIX) * Aquestive Therapeutics Inc (NASDAQ: AQST) * Aravive Inc (NASDAQ: ARAV) * Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) * Atara Biotherapeutics Inc (NASDAQ: ATRA) * Atossa Therapeutics Inc (NASDAQ: ATOS) * Autolus Therapeutics Ltd - ADR (NASDAQ: AUTL) * AVEO Pharmaceuticals, Inc. ((NASDAQ: AVEO) * AxoGen, Inc Common Stock (NASDAQ: AXGN) * Axovant Gene Therapies Ltd (NASDAQ: AXGT) * Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) * BioCardia Inc (NASDAQ: BCDA) * BioSig Technologies Inc (NASDAQ: BSGM) * BioTelemetry Inc (NASDAQ: BEAT) * Black Diamond Therapeutics Inc (NASDAQ: BDTX) * CASI Pharmaceuticals Inc (NASDAQ: CASI) * Catabasis Pharmaceuticals Inc (NASDAQ: CATB) * CELYAD SA/ADR (NASDAQ: CYAD) * Cerecor Inc (NASDAQ: CERC) * Champions Oncology Inc (NASDAQ: CSBR) * Chiasma Inc (NASDAQ: CHMA) * CNS Pharmaceuticals Inc (NASDAQ: CNSP) * Corvus Pharmaceuticals Inc (NASDAQ: CRVS) * Edap Tms SA (NASDAQ: EDAP) * Ekso Bionics Holdings Inc (NASDAQ: EKSO) * Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) * Enochian Biosciences Inc (NASDAQ: ENOB) * Entasis Therapeutics Holdings Inc (NASDAQ: ETTX) * Eton Pharmaceuticals Inc (NASDAQ: ETON) * Evolus Inc (NASDAQ: EOLS) * Five Prime Therapeutics Inc (NASDAQ: FPRX) * Gritstone Oncology Inc (NASDAQ: GRTS) * GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) * Heron Therapeutics Inc (NASDAQ: HRTX) * Ideaya Biosciences Inc (NASDAQ: IDYA) * Idera Pharmaceuticals Inc (NASDAQ: IDRA) * Illumina, Inc. (NASDAQ: ILMN) * ImmuCell Corporation (NASDAQ: ICCCv * Integra Lifesciences Holdings Corp (NASDAQ: IART) * Ionis Pharmaceuticals Inc (NASDAQ: IONS) * Jaguar Health Inc (NASDAQ: JAGX) * Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) * Kalvista Pharmaceuticals Inc (NASDAQ: KALV) * Kamada Ltd. (NASDAQ: KMDA) * KITOV PHARMA LT/S ADR (NASDAQ: KTOV) * Kura Oncology Inc (NASDAQ: KURA) * Lantheus Holdings Inc (NASDAQ: LNTH) * MacroGenics Inc (NASDAQ: MGNX) * TapImmune Inc. common stock (NASDAQ: MRKR) * MediciNova, Inc. (NASDAQ: MNOV) * Medigus Ltd. (NASDAQ: MDGS) * MeiraGTx Holdings PLC (NASDAQ: MGTX) * Meridian Bioscience, Inc. (NASDAQ: VIVO) * Merrimack Pharmaceuticals Inc (NASDAQ: MACK) * Misonix Inc (NASDAQ: MSON) * Moleculin Biotech Inc (NASDAQ: MBRX) * Monopar Therapeutics Inc (NASDAQ: MNPR) * Mustang Bio Inc (NASDAQ: MBIO) * Myriad Genetics, Inc. (NASDAQ: MYGN) * Neovasc Inc (NASDAQ: NVCN) * Neurometrix Inc (NASDAQ: NURO) * NuVasive, Inc. (NASDAQ: NUVA) * Orchard Therapeutics PLC - ADR (NASDAQ: ORTX) * Organogenesis Holdings Inc (NASDAQ: ORGO) * Oxford Immunotec Global PLC (NASDAQ: OXFD) * Pacira Biosciences Inc (NASDAQ: PCRX) * Pfizer Inc. (NYSE: PFE) * Phio Pharmaceuticals Corp (NASDAQ: PHIO) * Pieris Pharmaceuticals Inc (NASDAQ: PIRS) * Plus Therapeutics Inc (NASDAQ: PSTV) * Polarityte Inc (NASDAQ: PTE) * Precigen Inc (NASDAQ: PGEN) * Predictive Oncology Inc (NASDAQ: POAI) * Psychemedics Corp. (NASDAQ: PMD) * Pulse Biosciences Inc (NASDAQ: PLSE) * Rhythm Pharmaceuticals Inc (NASDAQ: RYTM) * Rubius Therapeutics Inc (NASDAQ: RUBY) * SAGE Therapeutics Inc (NASDAQ: SAGE) * Salarius Pharmaceuticals Inc (NASDAQ: SLRX) * Spero Therapeutics Inc (NASDAQ: SPRO) * Stealth BioTherapeutics Corp (NASDAQ: MITO) * Stemline Therapeutics Inc (NASDAQ: STML) * Stoke Therapeutics Inc (NASDAQ: STOK) * SurModics, Inc. (NASDAQ: SRDX) * Synlogic Inc (NASDAQ: SYBX) * T2 Biosystems Inc (NASDAQ: TTOO) * Tcr2 Therapeutics Inc (NASDAQ: TCRR) * Teligent Inc (NEW JERSEY) (NASDAQ: TLGT) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) * Theratechnologies Inc (NASDAQ: THTX) * Titan Medical Inc. (NASDAQ: TMDI) * TRACON Pharmaceuticals Inc (NASDAQ: TCON) * Unum Therapeutics Inc (NASDAQ: UMRX) * Vericel Corp (NASDAQ: VCEL) * Viking Therapeutics Inc (NASDAQ: VKTX) * Viveve Medical Inc (NASDAQ: VIVE) * VIVUS, Inc. (NASDAQ: VVUS) * Voyager Therapeutics Inc (NASDAQ: VYGR) * X T L Biopharmaceuticals Ltd (NASDAQ: XTLB) * Xencor Inc (NASDAQ: XNCR) * ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) * Zimmer Biomet Holdings Inc (NYSE: ZBH)See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates Stocks In Focus AstraZeneca-Merck's Ovarian Cancer Combo Therapy Fails To Meet Primary Endpoint In Late-stage study AstraZeneca plc (NYSE: AZN) and Merck & Co., Inc. (NYSE: MRK) said the Phase 3 study dubbed GY004 that evaluated cediranib in combination with Lynparza versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer did not meet the primary endpoint of progression-free survival.Achieve Life Sciences Says Investigational Smoking Cessation Drug Showed Efficacy In Midstage Trial Ahead of a planned presentation of additional analyses of results from the ORCA-1 Phase 2b trial of cytisinicline at the SRNT annual meeting being held in New Orleans, Achieve Life Sciences said new analyses demonstrated cytisinicline's biochemical efficacy through measurement of serum cotinine as well as the previously treated carbon monoxide efficacy."The additional analyses further validate our belief that cytisinicline could be an effective aid to smoking cessation regardless of demographics, prior smoking history, or numerous quit attempts," said Dr. Cindy Jacobs, Chief Medical Officer of Achieve.The stock was seen adding 3.98% to 43 cents in pre-market trading.Mallinckrodt To Explore Inhaled Nitric Oxide As Supportive Treatment Option For COVID-19 Mallinckrodt PLC (NYSE: MNK) said it's currently evaluating a potential role of inhaled nitric oxide as a supportive measure for treating patients infected with SARS-CoV-2 and having associated pulmonary complications. The company said it has engaged with the U.S. FDA, NIH and BARDA.The company currently markets iNO as INOmax gas for inhalation in the U.S. for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.In pre-market trading, Mallinckrodt shares were rallying 12.13% to $3.42.AbbVie Gets European Nod For Leukemia Combo Regimen AbbVie Inc (NYSE: ABBV) said the European Commission has approved its Venclyxto in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia who were previously untreated. AbbVie is partnering with Roche Holdings AG Basel ADR (OTC: RHHBY) for developing Venclyxto.Clearside Confirms George Lasezkay As CEO Clearside Biomedical Inc (NASDAQ: CLSD) has appointed George Lasezkay as CEO, effective March 1. Lasezkay had held the position on an interim basis ahead of the recent appointment. Separately, the company reported flat revenues of $1.9 million and a narrower loss of 7 cents per share, in line with the consensus.The stock eased 0.77% to $2.57 in after-hours trading.Teva's Ajovy Recommended by U.K.'s Health Advisory Body Teva Pharmaceutical Industries Ltd (NYSE: TEVA) said the National Institute for Health and Care Excellence, or NICE, has recommended its Ajovy in its Final Appraisal Document for the prevention of migraine in adults with chronic migraine and who have not responded to at least three prior preventive drug treatments.NICE is an independent public body that provides national guidance and advice to improve health and social care in the U.K.Amneal Announces New CFO Amneal Pharmaceuticals Inc (NYSE: AMRX) has appointed pharma industry veteran Tasos Konidaris as CFO, effective March 12. Konidaris will replace Todd Branning, who despite relinquishing office as CFO is available for the company through March 31.The stock rose 1.54% to $3.30 in after-hours trading.Flexion Appoints Melissa Layman As Chief Commercial Officer Flexion Therapeutics Inc (NASDAQ: FLXN) announced the appointment of Melissa Layman as Chief Commercial Officer. Layman, according to the company, has 25 years of commercial experience within the life science industry."She combines deep and broad commercial expertise with important leadership experience and a strong track record of success. I am confident that she will make a very real difference for us and for patients on the journey to realizing the potential of ZILRETTA," said Michael Clayman, CEO of Flexion.The stock rose 3.57% to $12.75 in after-hours trading.Emergent Biosolutions To Begin Clinical Study Of COVID-19 Treatment In Q3 Emergent Biosolutions Inc (NYSE: EBS) has initiated development of two product candidates for the treatment and prevention of COVID-19 on its hyperimmune platforms.View more earnings on MNKThe company said it has initiated plasma collection efforts for both human and equine platforms with the goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter of 2020.The stock moved up 0.82% to $53.47 in after-hours trading.Global Medical To Buy Back $200M Worth Of Shares Globus Medical Inc (NYSE: GMED) said its board has authorized repurchase of $200 million of its common stock.Earnings Ovid Therapeutics Inc (NASDAQ: OVID) reported a net loss of 35 cents per share for the fourth quarter, narrower than the year-ago loss of 52 cents per share. Analysts expected a loss of 41 cents per share for the quarter.The stock jumped 16.79% to $3.13 in after-hours trading.Aquestive Therapeutics' revenues for the fourth quarter declined from $16.8 million in 2018 to $16.4 million in 2019. The net loss per share, however, narrowed from 56 cents to 48 cents per share. For the full year 2020, the company expects revenues of $35 million to $45 million, in line with the consensus estimate.The stock gained 8.84% to $3.20 in after-hours trading.Arcturus Therapeutics Ltd (NASDAQ: ARCT) reported a decline in its fourth-quarter revenues from $7.58 million in 2018 to $2.97 million in 2019. The net loss widened from 10 cents per share to 76 cents per share.The stock moved up 6.95% to $14 in after-hours trading.Offerings Seelos Therapeutics Inc (NASDAQ: SEEL) said it has priced its underwritten public offering of 7.5 million shares at 60 cents per share. All the shares are to be offered by the company. The company expects to raise net proceeds of $3.9 million from the offering. The offering would close on or about March 16, Seelos said.The stock plunged 17.95% to 64 cents in after-hours trading.Close on heels of its decision to enter the fray to develop a treatment for COVID-19, Tiziana announced a follow-on offering of 3.33 million ADS representing 16.67 million shares at $3 per ADS for raising gross proceeds of about $10 million. The company expects the offering to close on March 16.The stock added 6.33% to $4.20 in after-hours trading.On The Radar Earnings • Avadel Pharmaceuticals PLC (NASDAQ: AVDL) (before the market open) • Axsome Therapeutics Inc (NASDAQ: AXSM) (before the market open) • Aldeyra Therapeutics Inc (NASDAQ: ALDX) (before the market open) • Selecta Biosciences Inc (NASDAQ: SELB) (before the market open) • Polarityte Inc (NASDAQ: PTE) (before the market open) • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (before the market open) • Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open) • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open) • Provention Bio Inc (NASDAQ: PRVB) (before the market open) • Protalix Biotherapeutics Inc (NYSE: PLX) (before the market open) • Evofem Biosciences Inc (NASDAQ: EVFM) (before the market open) • China Biologic Products Holdings Inc (NASDAQ: CBPO) (before the market open) • Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) (before the market open) • Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open) • X4 Pharmaceuticals Inc (NASDAQ: XFOR) (before the market open) • Polarityte Inc (NASDAQ: PTE) (before the market open) • Rubius Therapeutics Inc (NASDAQ: RUBY) (before the market open) • Agenus Inc (NASDAQ: AGEN) (before the market open) • ADMA Biologics Inc (NASDAQ: ADMA) (after the close) • BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (after the close) • Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) (after the close) • Celcuity Inc (NASDAQ: CELC) (after the close) • Lineage Cell Therapeutics Inc (NYSE: LCTX) (after the close) • Chembio Diagnostics Inc (NASDAQ: CEMI) (after the close) • Harpoon Therapeutics Inc (NASDAQ: HARP) (after the close) • Flexion (after the close) • Neoleukin Therapeutics Inc (NASDAQ: NLTX) (after the close) • Rockwell Medical Inc (NASDAQ: RMTI) (after the close) • Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the close) • Savara Inc (NASDAQ: SVRA) (after the close) • Ocular Therapeutix Inc (NASDAQ: OCUL) (after the close) • Y-mAbs Therapeutics, Inc (NASDAQ: YMAB) (after the close) • Amphastar Pharmaceuticals Inc (NASDAQ: AMPH) (after the close) • CymaBay Therapeutics Inc (NASDAQ: CBAY) (after the close) • Adverum Biotechnologies Inc (NASDAQ: ADVM) (after the close) • Geron Corporation (NASDAQ: GERN) (after the close) • CNS Pharmaceuticals (after the close) • Nabriva Therapeutics PLC - ADR (NASDAQ: NBRV) (after the close) • Synlogic (after the close)IPOs Imara, a biopharma company that is developing therapies for rare hemoglobinopathies, priced its upsized IPO of 4.70 million shares at $16, the lower bound of the previously estimated price range of $16-$18. The company's shares will be listed on the Nasdaq under the ticker symbol IMRA.See more from Benzinga * The Daily Biotech Pulse: NY State Endorses Mallinckrodt's Opioid Settlement, Kamada To Work On COVID-19 Treatment * The Daily Biotech Pulse: Breakthrough Device Designation For Neuronetics, AbbVie Receives European Label Expansion, AstraZeneca Flunks Late-Stage Study * The Daily Biotech Pulse: Takeda Jumps Into The COVID-19 Fray, Exact Sciences Buys Cancer Diagnostics Companies(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Mallinckrodt Evaluates the Potential Role for Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications, Engages with Scientific, Governmental and Regulatory Agencies
    PR Newswire

    Mallinckrodt Evaluates the Potential Role for Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications, Engages with Scientific, Governmental and Regulatory Agencies

    Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today commented that it is currently evaluating the limited published evidence suggesting a potential role for inhaled nitric oxide ("iNO") as a supportive measure in treating those patients infected with coronavirus (SARS-CoV-2) and having associated pulmonary complications. The company has engaged with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) on this matter; however, the safety and efficacy of iNO for pulmonary complications associated with coronavirus have not been established.

  • The Daily Biotech Pulse: NY State Endorses Mallinckrodt's Opioid Settlement, Kamada To Work On COVID-19 Treatment
    Benzinga

    The Daily Biotech Pulse: NY State Endorses Mallinckrodt's Opioid Settlement, Kamada To Work On COVID-19 Treatment

    Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week highs on March 10) * Arcutis Biotherapeutics Inc (NASDAQ: ARQT) * Aytu Bioscience Inc (NASDAQ: AYTU) (announced a deal to distribute COVID-19 test) * Centogene NV (NASDAQ: CNTG) * Forty Seven Inc (NASDAQ: FTSV)Down In The Dumps(Biotech Stocks Hitting 52-week lows on March 10) * Accelerate Diagnostics Inc (NASDAQ: AXDX) * Adamas Pharmaceuticals Inc (NASDAQ: ADMS) * Adaptive Biotechnologies Corp (NASDAQ: ADPT) * ADMA Biologics Inc (NASDAQ: ADMA) * Aeglea Bio Therapeutics Inc (NASDAQ: AGLE) * AEterna Zentaris Inc. (NASDAQ: AEZS) * Affimed NV (NASDAQ: AFMD) * Akari Therapeutics PLC (NASDAQ: AKTX) * Akcea Therapeutics Inc (NASDAQ: AKCA) * Aldeyra Therapeutics Inc (NASDAQ: ALDX) * Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) * Alkermes Plc (NASDAQ: ALKS) * Allena Pharmaceuticals Inc (NASDAQ: ALNA) * ANCHIANO THERAP/S ADR (NASDAQ: ANCN) * AngioDynamics, Inc. (NASDAQ: ANGO) * ANI Pharmaceuticals Inc (NASDAQ: ANIP) * Anixa Biosciences Inc (NASDAQ: ANIX) * AnPac Bio-Medical Science Co Ltd - ADR (NASDAQ: ANPC) * Aptevo Therapeutics Inc (NASDAQ: APVO) * Aptinyx Inc (NASDAQ: APTX) * Assertio Therapeutics Inc (NASDAQ: ASRT) * Atara Biotherapeutics Inc (NASDAQ: ATRA) * Atossa Therapeutics Inc (NASDAQ: ATOS) * Autolus Therapeutics Ltd - ADR (NASDAQ: AUTL) * AxoGen, Inc Common Stock (NASDAQ: AXGN) * Axovant Gene Therapies Ltd (NASDAQ: AXGT) * Bausch Health Companies Inc (NYSE: BHC) * Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) * BENITEC BIOPHAR/S ADR (NASDAQ: BNTC) * BioLife Solutions Inc (NASDAQ: BLFS) * bluebird bio Inc (NASDAQ: BLUE) * Black Diamond Therapeutics Inc (NASDAQ: BDTX) * Capricor Therapeutics Inc (NASDAQ: CAPR) * Celcuity Inc (NASDAQ: CELC) * Cerecor Inc (NASDAQ: CERC) * Chembio Diagnostics Inc (NASDAQ: CEMI) * Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) * Enochian Biosciences Inc (NASDAQ: ENOB) * Entasis Therapeutics Holdings Inc (NASDAQ: ETTX) * Eton Pharmaceuticals Inc (NASDAQ: ETON) * Evolus Inc (NASDAQ: EOLS) * Exicure Inc (NASDAQ: XCUR) * Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) * Five Prime Therapeutics Inc (NASDAQ: FPRX) * Gossamer Bio Inc (NASDAQ: GOSS) * Gritstone Oncology Inc (NASDAQ: GRTS) * GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) * Heron Therapeutics Inc (NASDAQ: HRTX) * Incyte Corporation (NASDAQ: INCY) * INmune Bio Inc (NASDAQ: INMB) * Integra Lifesciences Holdings Corp (NASDAQ: IART) * Invivo Therapeutics Holdings Corp (NASDAQ: NVIV) * Jaguar Health Inc (NASDAQ: JAGX) * Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) * Kura Oncology Inc (NASDAQ: KURA) * Lantheus Holdings Inc (NASDAQ: LNTH) * TapImmune Inc. common stock (NASDAQ: MRKR) * MediciNova, Inc. (NASDAQ: MNOV) * Meridian Bioscience, Inc. (NASDAQ: VIVO) * Misonix Inc (NASDAQ: MSON) * Moleculin Biotech Inc (NASDAQ: MBRX) * Myriad Genetics, Inc. (NASDAQ: MYGN) * Neovasc Inc (NASDAQ: NVCN) * Neurometrix Inc (NASDAQ: NURO)ccccc * Neuronetics Inc (NASDAQ: STIM) * Oncternal Therapeutics Inc (NASDAQ: ONCT) * Orchard Therapeutics PLC - ADR (NASDAQ: ORTX) * Organogenesis Holdings Inc (NASDAQ: ORGO) * Pieris Pharmaceuticals Inc (NASDAQ: PIRS) * Plus Therapeutics Inc (NASDAQ: PSTV) * Polarityte Inc (NASDAQ: PTE) * Portola Pharmaceuticals Inc (NASDAQ: PTLA) * Precigen Inc (NASDAQ: PGEN) * Precipio Inc (NASDAQ: PRPO) * Radius Health Inc (NASDAQ: RDUS) * Rhythm Pharmaceuticals Inc (NASDAQ: RYTM) * Rubius Therapeutics Inc (NASDAQ: RUBY) * SAGE Therapeutics Inc (NASDAQ: SAGE) * Stealth BioTherapeutics Corp (NASDAQ: MITO) * Stemline Therapeutics Inc (NASDAQ: STML) * SurModics, Inc. (NASDAQ: SRDX) * Synlogic Inc (NASDAQ: SYBX) * T2 Biosystems Inc (NASDAQ: TTOO) * Tcr2 Therapeutics Inc (NASDAQ: TCRR) * Teligent Inc (NEW JERSEY) (NASDAQ: TLGT) * Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) * TFF Pharmaceuticals Inc (NASDAQ: TFFP) * TRACON Pharmaceuticals Inc (NASDAQ: TCON) * Unum Therapeutics Inc (NASDAQ: UMRX) * Vericel Corp (NASDAQ: VCEL) * X4 Pharmaceuticals Inc (NASDAQ: XFOR) * Xeris Pharmaceuticals Inc (NASDAQ: XERS) * X T L Biopharmaceuticals Ltd (NASDAQ: XTLB) * ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates Stocks In Focus Mallinckrodt's Global Opioid Settlement Agreement Endorsed By New York State Mallinckrodt PLC (NYSE: MNK) said the New York State Attorney General Letitia James lent support to the company's previously announced global opioid settlement, joining 47 other states and U.S. Territory Attorneys General.The State of New York and Suffolk County, together with Mallinckrodt and SpecGx LLC, have jointly filed a motion to remove the companies from the New York State opioid trial.In pre-market trading, shares were rising 13.24% to $2.48.Kamada to Work On Treatment for Severely Ill COVID-19 Patients Israeli plasma-derived biopharma Kamada Ltd. (NASDAQ: KMDA) said it plans to initiate the development of an Anti-COVID-19 polyclonal immunoglobin using is its proprietary plasma derived IgG platform technology as a potential treatment for severely ill coronavirus patients."We are working with the Israeli regulatory authorities and local medical institutions to advance our program," said Amir London, CEO of Kamada.In pre-market trading, shares were up 6.23% to $5.80.FDA Approves Bristol-Myers' Opdivo-Yervoy Combo For Liver Cancer Bristol-Myers Squibb Co's (NYSE: BMY) said the FDA approved its sBLA for Opdivo + Yervoy as a treatment option for patients with advanced hepatocellular carcinoma, previously treated with Bayer AG (OTC: BAYRY) and Onyx Pharma's Nexavar.Phio Pharma Announces Agreement to Develop Immune Enhancers Phio Pharmaceuticals Corp (NASDAQ: PHIO) has reached a new agreement with Medigene relating to its previously announced research collaboration with Helmholtz Zentrum Munchen to develop novel candidates for the use of Intasyl compounds in adoptive cell therapy to enhance immune function.The new agreement provides for Medigene contributing expertise regarding clinical development and proprietary research material. The company also has an option to an exclusive license for potential immune cell enhancers against certain fee payments.Phio shares rallied 15.30% to $3.24 in after-hours trading.NuCana's Ovarian Cancer Drug Shows Favorable Disease Control In Midstage Study NuCana PLC (NASDAQ: NCNA) announced preliminary results from part one of the Phase 2 study of single-agent Acelarin in difficult-to-treat patients with platinum-resistant ovarian cancer, which showed that out of the 45 evaluable patients, one patient achieved a complete response and two patients achieved partial responses, while 16 achieved stable disease."We are pleased with this favorable disease control rate and Acelarin's ability to achieve confirmed complete and partial responses in this very heavily pre-treated patient population," said Hugh Griffith, CEO of NuCana.Separately, the company reported fourth-quarter results showing a wider loss.View more earnings on MNKNuCana shares rose 7.25% to $7.25 in after-hours trading.Sophiris Bio Shares to Be Delisted From Nasdaq, Effective March 12 Sophiris Bio Inc (NASDAQ: SPHS), which is evaluating its topsalysin in late-stage clinical trials for urological diseases, said the Nasdaq Officer of General Counsel informed the company that the Nasdaq Hearing Panel has determined to delist its shares from the Nasdaq. Trading in the company's shares are to be suspended, effective at the open of business March 12.The company said it expects its shares to be eligible for trading on the OTC.The delisting comes in the wake of the company flouting listing standards pertaining to the minimum $2.5 million stockholder's equity requirement.The stock plummeted 39.58% to 35 cents in the after-hours trading.J&J's Lung Cancer Therapy Gets Breakthrough Designation Johnson & Johnson (NYSE: JNJ) said its Janssen unit's JNJ-61186372 has been granted Breakthrough Therapy Designation by the FDA for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.Roche's Biomarker-based Screening Test For Cervical Cancer Approved by FDARoche Holdings AG Basel ADR (OTC: RHHBY) said the FDA approved its CINtec PLUS Cytology, as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for HPV using the cobas 4800 HPV Test.Altimmune Soars Despite No NewsAltimmune Inc (NASDAQ: ALT) shares were sharply higher in after-hours trading, although there was no release from the company.Earnings RA Medical Systems Inc (NYSE: RMED) reported a decline in is fourth-quarter revenues from $2 million in 2018 to $1.4 million in 2019. The net loss per share narrowed from $1.18 to 72 cents. Analysts estimated a loss of $1.15 per share.The stock plunged 39.72% to 85 cents in after-hours trading.Fulgent Genetics Inc's (NASDAQ: FLGT) fourth-quarter revenues climbed 48% year-over-year to $8.4 million and the company reported non-GAAP EPS of 4 cents, in line with the consensus estimate.The stock 4.92% to $14.50 in after-hours trading.Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) reported fourth-quarter revenues of $2.07 million in 2019 compared to no revenues a year ago. The net loss per share narrowed from 16 cents to 5 cents, while analysts estimated a loss of 7 cents per share.The stock slipped 5.21% to 91 cents in after-hours trading.Offerings Kala Pharmaceuticals Inc (NASDAQ: KALA) said it has priced its underwritten public offering of 16 million shares at $7.89 per share, for generating gross proceeds of $126.2 million. The company expects the offering to close March 13.In premarket trading Wednesday, Kala shares were adding 11.53% to $8.80.On The Radar Earnings • Xeris Pharma (before the market open) • Liquidia Technologies Inc (NASDAQ: LQDA) (before the market open) • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open) • INmune Bio Inc (NASDAQ: INMB) (before the market open) • Clearside Biomedical Inc (NASDAQ: CLSD) (after the close) • Calithera Biosciences Inc (NASDAQ: CALA) (after the close) • Unity Biotechnology Inc (NASDAQ: UBX) (after the close) • Navidea Biopharmaceuticals Inc (NYSE: NAVB) (after the close) • Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the close) • BioLife Solutions Inc (NASDAQ: BLFS) (after the close) • Dynavax Technologies Corporation (NASDAQ: DVAX) (after the close) • Miragen Therapeutics Inc (NASDAQ: MGEN) (after the close) • Pfenex Inc (NYSE: PFNX) (after the close) • Arcturus Therapeutics Ltd (NASDAQ: ARCT) (after the close) • Novavax, Inc. (NASDAQ: NVAX) (after the close) • Global Cord Blood Corp (NYSE: CO) (after the close)See more from Benzinga * The Daily Biotech Pulse: Mesoblast To Test Candidate On Coronavirus Symptoms, Proxy Battle Ahead For Rockwell Medical, Glaukos to Join S&P SmallCap 600 Index * The Week Ahead In Biotech (March 8-14): Bristol-Myers Awaits FDA Nod For Liver Cancer Combo Therapy, Earnings Flow Continues * The Daily Biotech Pulse: Takeda Jumps Into The COVID-19 Fray, Exact Sciences Buys Cancer Diagnostics Companies(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Mallinckrodt Provides Update on Proposed Global Opioid Settlement
    PR Newswire

    Mallinckrodt Provides Update on Proposed Global Opioid Settlement

    Mallinckrodt plc (NYSE: MNK) ("Mallinckrodt" or the "Company") today announced that New York State Attorney General Letitia James has joined 47 other state and U.S. Territory Attorneys General in supporting the previously announced proposed global opioid settlement with Mallinckrodt and related entities.

  • Thomson Reuters StreetEvents

    Edited Transcript of MNK earnings conference call or presentation 25-Feb-20 1:30pm GMT

    Q4 2019 Mallinckrodt Plc Earnings Call

  • Are Options Traders Betting on a Big Move in Mallinckrodt (MNK) Stock?
    Zacks

    Are Options Traders Betting on a Big Move in Mallinckrodt (MNK) Stock?

    Investors need to pay close attention to Mallinckrodt (MNK) stock based on the movements in the options market lately.

  • Data on Acthar® Gel (Repository Corticotropin Injection) Therapy in Immunoglobulin A Nephropathy (IgAN) Published in Kidney International Reports
    PR Newswire

    Data on Acthar® Gel (Repository Corticotropin Injection) Therapy in Immunoglobulin A Nephropathy (IgAN) Published in Kidney International Reports

    Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced publication of findings from a prospective, open-label pilot study to assess the efficacy and safety of Acthar® Gel (repository corticotropin injection) in patients with immunoglobulin A nephropathy (IgAN) at high risk of chronic kidney disease progression.1 The study was published in Kidney International Reports, the journal of the International Society of Nephrology. IgAN, also known as Berger's disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues2,3

  • The Daily Biotech Pulse: Takeda Jumps Into The COVID-19 Fray, Exact Sciences Buys Cancer Diagnostics Companies
    Benzinga

    The Daily Biotech Pulse: Takeda Jumps Into The COVID-19 Fray, Exact Sciences Buys Cancer Diagnostics Companies

    Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week highs on March 3) * Acceleron Pharma Inc (NASDAQ: XLRN) * BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) * Fate Therapeutics Inc (NASDAQ: FATE) (reacted to its fourth-quarter results) * Forty Seven Inc (NASDAQ: FTSV) * IGM Biosciences Inc (NASDAQ: IGMS) * Inovio Pharmaceuticals Inc (NASDAQ: INO)( announced an accelerated timeline for COVID-19 vaccine development) * Repro-Med Systems, Inc. (NASDAQ: KRMD) * SpringWorks Therapeutics Inc (NASDAQ: SWTX) * Zynex Inc. (NASDAQ: ZYXI)Down In The Dumps (Biotech Stocks Hitting 52-week lows on March 3) * ADDEX THERAPEUT/ADR (NASDAQ: ADXN) * Akorn, Inc. (NASDAQ: AKRX) * Aldeyra Therapeutics Inc (NASDAQ: ALDX) * ANI Pharmaceuticals Inc (NASDAQ: ANIP) * Evolus Inc (NASDAQ: EOLS) * EXACT Sciences Corporation (NASDAQ: EXAS) * HTG Molecular Diagnostics Inc (NASDAQ: HTGM) * Midatech Pharma PLC-ADR (NASDAQ: MTP)(began trading on a reverse split adjusted basis) * Mylan NV (NASDAQ: MYL) * Neuronetics Inc (NASDAQ: STIM)(announced its fourth-quarter results) * Passage Bio Inc (NASDAQ: PASG)(IPOed last week) * STRATA Skin Sciences Inc (NASDAQ: SSKN) * SurModics, Inc. (NASDAQ: SRDX) * Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) * TransMedics Group Inc (NASDAQ: TMDX)(reported its fourth-quarter results) * VIVUS, Inc. (NASDAQ: VVUS) * Xeris Pharmaceuticals Inc (NASDAQ: XERS)See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA DatesStocks In Focus Takeda To Develop COVID-19 Treatments Takeda Pharmaceutical Co Ltd (NYSE: TAK) said it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin to treat high-risk individuals with the viral infection. Hyperimmune globulins are plasma-derived therapies that had previously proven its efficacy in treating severe acute viral respiratory infections.The company added it is also studying its currently marketed and pipeline products to see whether they are effective treatments for infected patients.Separately, the company said it has completed its previously announced sale of portfolio of select products to STADA for $660 million.In pre-market trading Wednesday, Takeda shares were adding 3.94% to $18.20.Vir, Alnylam Expands Collaboration To Develop siRNA Therapies For COVID-19 Vir Biotechnology Inc (NASDAQ: VIR) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced an expansion to their existing collaboration to include the development and commercialization of RNAi therapeutics against COVID-19. The agreement provides for Vir using Alnylam's recent advances in lung delivery of novel conjugates of siRNA along with its infectious disease expertise to develop one or some siRNAs to treat COVID-19 and other coronaviruses as well.In premarket trading Wednesday, Vir share were rallying 14.72% to $47 and Alnylam was edging up 0.41% to $111.88.Mallinckrodt Reports Positive Outcome Analysis of Acthar Gel In Immune-mediated Diseases Mallinckrodt PLC (NYSE: MNK) announced findings from a retrospective medical record analysis, which assessed practice patterns and outcomes of Acthar Gel in the treatment of immune-mediated diseases rheumatoid arthritis, systemic lupus erythematosus and dermatomyositis/polymyositis, which showed across all the three patient populations, symptoms improved with Acthar Gel.In premarket trading Wednesday, the shares were advancing 7.99% $3.38.Acadia's Rett Syndrome Investigational Drug Gets Rare Pediatric Designation ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) and Neuren Pharma said the FDA has granted Rare Pediatric Disease designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder.Upon approval of a product with the designation, the sponsor is eligible to receive a Priority Review Voucher, which can be used to obtain FDA approval of an NDA for another product in an expedited period of six months.Acadia shares were up 2.41% to $42.99 in after-hours trading.Morphosys' Licensing Agreement With Incyte For Lymphoma Drug Gets Antitrust Clearance Morphosys Ag (NASDAQ: MOR) and Incyte Corporation (NASDAQ: INCY) said their joint collaboration and license agreement for further development and global commercialization of Morphosys' investigational compound tafasitamab has received antitrust clearance and becomes effective Tuesday.The regulatory milestone triggers a $750 million upfront payment by Incyte to Morphosys, and also Incyte's equity investment of $150 million into MorphoSys within the defined timelines.The PDUFA date for the BLA for tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma is Aug. 30.Ultragenyx CFO To Step Down Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) said Shalini Sharp will step down as CFO and EVP, effective Sept. 2. The company said it will initiate a search for a successor.Exact Sciences Buys Two Cancer Diagnostics Companies Exact Sciences said it has completed its acquisition of Paradigm Diagnostics and Viomics, two privately held companies, which provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery.View more earnings on TAKThe company expects the acquisition to extend its lab testing and research and development capabilities.J&J Makes Regulatory Submission For Approval of Multiple Sclerosis Drug In Europe Johnson & Johnson's (NYSE: JNJ) Janssen unit announced it submitted a Marketing Authorization Application to EMA, seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis.Earnings DURECT Corporation (NASDAQ: DRRX) reported fourth-quarter net revenues of $10.69 million compared to $3.63 million last year. The net loss per share narrowed from 5 cents to 2 cents, in line with the consensus estimate.The stock jumped 12.21% to $1.93 in after-hours trading.Menlo Therapeutics Inc's (NASDAQ: MNLO), which has agreed to be bought by Foamix Pharmaceuticals Ltd (NASDAQ: FOMX), reported a wider loss of 89 cents per share compared to the year-ago loss of 76 cents per share and the consensus loss estimate of 83 cents per share.Updating on the pending merger, Menlo said it expects it to close March 9.The stock jumped 23.64% to $3.40 in after-hours trading.Voyager Therapeutics Inc (NASDAQ: VYGR) reported fourth quarter revenues of $32.67 million compared to $2.01 million a year ago. The net loss per share narrowed from 77 cents to 34 cents. Analysts had estimated a loss of 81 cents per share. The company said it expects its cash reserves as well as receivables to be sufficient to meet its projected operating expenses and capex into mid-2022.The stock gained 6.22% to $12.30 in after-hours trading.Vivus reported fourth-quarter total revenues of $17.25 million and a loss of 61 cents per share, narrower than the 68 cents per share loss expected by analysts.The stock rose 8.98% to $1.82 in after-hours trading.Offerings Zogenix, Inc. (NASDAQ: ZGNX) said it has priced its underwritten public offering of 8.52 million shares at $23.50 per share. The company expects to raise gross proceeds of $200.2 million from the offering. The offering is expected to close on or about March 6.The company said it expects to use the net proceeds for the potential commercialization of Fintepla for the treatment of Dravet syndrome, among other things.The stock fell 3.69% to $24 in after-hours trading.On The Radar Earnings * AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (before the market open) * Recro Pharma Inc (NASDAQ: REPH) (before the market open) * PPD Inc (NASDAQ: PPD) (before the market open) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) (after the close) * Orthopediatrics Corp (NASDAQ: KIDS) (after the close) * Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (after the close)See more from Benzinga * The Daily Biotech Pulse: GenMark Diagnostics Ships COVID-19 Test Kits, Karyopharm To Offer Shares, And More * The Daily Biotech Pulse: Sangamo In Genome-Editing Therapy Deal With Biogen, FDA Nod For Biohaven, Passage Bio IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Mallinckrodt Announces Publication of New Data on Acthar® Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis, Systemic Lupus Erythematosus and Dermatomyositis/Polymyositis Published in Open Access Rheumatology: Research and Reviews
    PR Newswire

    Mallinckrodt Announces Publication of New Data on Acthar® Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis, Systemic Lupus Erythematosus and Dermatomyositis/Polymyositis Published in Open Access Rheumatology: Research and Reviews

    Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced findings from a retrospective medical record analysis to assess practice patterns and outcomes of Acthar® Gel (repository corticotropin injection) in the treatment of the immune-mediated diseases rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and dermatomyositis/polymyositis (DM/PM). Results of the study were recently published online in Open Access Rheumatology: Research and Reviews.

  • MarketWatch

    Mallinckrodt's stock plunges after report of DOJ suit for alleged underpayment of Medicaid rebates

    Shares of Mallinckrodt PLC plummeted 26% in afternoon trading Tuesday, to pace all NYSE decliners, after Dow Jones Newswire reported that U.S. regulators has sued the specialty drug maker's subsidiary for allegedly underpaying Medicaid rebates. The Justice Department alleged that Mallinckrodt ARD LLC starting paying rebates as if its H.P. Acthar Gel drug was a new drug first marketed in 2013, but it was actually first marketed in 1990, the DJN report said. The subsidiary, which was previously known as Questcor Pharmaceuticals Inc., had allegedly raised the price of Acthar, which could be used to treat multiple sclerosis and rheumatoid arthritis, by more than $20,000 per unit before 2013, and it avoided paying higher rebates on the pre-2013 prices, the report said. Drugmakers are required to pay rebates to Medicaid programs in return for Medicaid's coverage of manufacturers' drugs, and the Medicaid Drug Rebate program's intent was to prevent price increases of drugs in its coverage to rise faster than inflation, the report explained. Mallinckrodt was also embroiled in litigation over the opioid crisis. The stock has plunged 87% over the past 12 months, while the S&P 500 has gained 6.3%.

  • U.S. sues Mallinckrodt, accuses drugmaker of defrauding Medicaid
    Reuters

    U.S. sues Mallinckrodt, accuses drugmaker of defrauding Medicaid

    Joining a civil whistleblower lawsuit filed in Boston federal court, the government said Mallinckrodt ARD LLC violated the federal False Claims Act by withholding Medicaid rebates related to Acthar, which now costs nearly $40,000 per vial. The drug is used to treat spasms in infants as well as multiple sclerosis, and generated about 30% of Mallinckrodt's $3.16 billion of net sales in the Staines-upon-Thames, England-based company's latest fiscal year. Mallinckrodt had sued the U.S. Department of Health and Human Services last May over the calculation of Acthar rebates, and said the judge there has barred any enforcement action while the case was pending.

  • Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)
    PR Newswire

    Mallinckrodt Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Patients with Hepatorenal Syndrome Type 1 (HRS-1)

    Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced it initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for terlipressin, an investigational agent being investigated for the treatment of hepatorenal syndrome type 1 (HRS-1), by submitting its clinical data package. A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.1 The company expects to complete the submission of the NDA in the coming months.

  • Mallinckrodt to Present New Data from two Studies on Acthar® Gel (Repository Corticotropin Injection) Therapy in Multiple Sclerosis (MS) Relapse at Fifth Annual ACTRIMS Forum 2020
    PR Newswire

    Mallinckrodt to Present New Data from two Studies on Acthar® Gel (Repository Corticotropin Injection) Therapy in Multiple Sclerosis (MS) Relapse at Fifth Annual ACTRIMS Forum 2020

    Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, announced today that it will present new data from two studies of Acthar® Gel (repository corticotropin injection) in multiple sclerosis (MS) relapse. The data will be highlighted in poster presentations at the Fifth Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020, held Feb. 27-29 in West Palm Beach, Florida.

  • Mallinckrodt Gains on Opioid Settlement, Beats on Q4 Earnings
    Zacks

    Mallinckrodt Gains on Opioid Settlement, Beats on Q4 Earnings

    Mallinckrodt (MNK) signs a $1.6-billion agreement for its ongoing opioid litigation and reports better-than-expected Q4 results.

  • Mallinckrodt gets 'much needed clarity' in $1.6B opioid settlement: Analysts
    American City Business Journals

    Mallinckrodt gets 'much needed clarity' in $1.6B opioid settlement: Analysts

    Analysts say settlement agreement marks the beginning of the drugmaker "retaking control of its broader business."

  • Generic drugmakers sold most opioids during overdose crisis
    MarketWatch

    Generic drugmakers sold most opioids during overdose crisis

    Mallinckrodt Pharmaceuticals doled out lavish perks for top U.S. employees who hit or beat sales goals for prescription opioids and other drugs: six-figure bonuses and a chance to snag a coveted “President’s Club” award, which could mean vacations to Hawaii, the Caribbean or Mexico.