Mallinckrodt Pharmaceuticals Aktie - Wkn: A1W0TN
und uns hier in Deutschland geht es doch ohnehin nicht schlecht. Im schlimmsten Fall gibt es eine Währungsreform und grundsätzlich bin ich der Überzeugung was einen potentiellen Krieg betrifft haben wir auch schon schlimmere Zeiten gesehen. Ich denke, grundsätzlich wird die Menschheit „vernünftiger“. Niemand will ernsthaft einen 3ten Weltkrieg! Da gäbe es nur Verlierer.....
Gruß Bronto
(Um Missverständnissen vorzubeugen: Nein, ich bin nicht gegen den Klimaschutz und zweifele den durch Menschen gemachten Klimawandel auch nicht an!)
Dow + 6% in der SPitze heute - ja es gab einen Grund - Arbeitlosenerstanträge USA - Experten haben 1,5 Mio s erwartet
Ergebnis - von 284.000 in einer WOche auf 3,3 Mios......hächster Anstieg seit 1982 in einer WOche - das muss man an der Bärse feiern.
Airbus - heute morgen - weitere Produktionskürzugen - AKtien unbeeindruckt - ab 14,30 20% plus danke USA das mein Ko bei 73 EUro sich in Luft aufgelöst hat.
Ölkonzerne in EUropa , ab 14.30 genauso diverse EUrostocx DIvidendentitel - ab die Post nach oben die letzten Tage.
Ölpreis unter 30 Dollar die ganzen Tage und Ölaktien im Durchschnitt über 25% hoch seit Freitag
Wie kann Shell +6% steigen während der Ölpreis um über -10% fällt ???
Sind das Zentralbanken die hier die Märkte mit Geld schwemmen? Ich verstehe die Welt nicht mehr..
Wer sich die Arbeit macht und Ende Mai die Q1 Zu und ABgänge bei den ÖLmulties ausrechnet wird mit Sicherheit zu dem Ergebnis kommen
WOOOW!!
DIe Logik ist toll in dem Artikel.
Wenn ich DOllar will warum nicht meine DOllaranleihen am Markt verkaufen? Warum als SIcherheit?
Achso ihr wollt nicht in Washington, das die ANleihekurse abstürzen, was einen Zinsschub nach OBEN bedeuten würde UND
das mit den "geliehenen" Dollars die anderen dann in die Börse einsteigen, wo ihr Amis euch schon mit Schnäppchen und Schlüsselindustrien wie ÖL mit Aktien vollgesaugt habt.
Mas sehen wieviel sorry - Deppen von anderen Zentralbanken diese Scheiss Repo Geschäfte mit den AMis machen, anstelle die Anleihen direkt zu verkaufen.
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Wertpapier: Mallinckrodt Pharmaceut |
Angehängte Grafik:
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Mallinckrodt and Novoteris, today, announced that the Therapeutic Products Directorate of Health Canada has cleared the companies' joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections" application to investigate the use of Thiolanox, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities.
The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters. The study will investigate the therapy's safety and effectiveness in treating COVID-19 and its associated lung complications. The companies expect to begin recruiting patients in the coming days.
The stock has been trading between $1.00 and $23.90 in the past one year, and closed Tuesday's trade at $1.98, down 27 cents or 12.00%. Trading volume was 6.62 million versus an average volume of 8.82 million shares.
For comments and feedback contact: editorial@rttnews.com
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Wertpapier: Mallinckrodt Pharmaceut |
Und dann das zugekaufte zu 80% wieder Mai/Juni verkaufen nach den Q1 Zahlen.
Mallinckrodt and Novoteris Receive Clearance from Health Canada to Start Pilot Trial of High-Dose Inhaled Nitric Oxide Therapy for COVID-19 Infection and Associated Lung Complications
-- Study to investigate antiviral activity and improvement in oxygenation and pulmonary arterial pressure in patients suffering from COVID-19 --
STAINES-UPON-THAMES, United Kingdom and GARDEN GROVE, Calif., April 1, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, today announced that the Therapeutic Products Directorate of Health Canada has cleared the companies' joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections" application to investigate the use of Thiolanox®, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities. The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters. The study will investigate the therapy's safety and effectiveness in treating COVID-19 and its associated lung complications. The companies expect to begin recruiting patients in the coming days.
Mallinckrodt logo
"Inhaled nitric oxide may have an antiviral effect, as well as improve oxygenation and pulmonary arterial pressure in patients suffering from COVID-19," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We're proud to be partnering with Novoteris on this pilot trial and are committed to increasing understanding of this potentially important therapeutic option for healthcare providers on the front lines of this unprecedented health emergency."
COVID-19 is a contagious respiratory illness caused by a novel coronavirus. Patients with COVID-19 have mild to severe respiratory illness that can include symptoms such as cough, fever and shortness of breath.1 In severe cases, COVID-19 can cause acute respiratory distress syndrome (ARDS) – a disorder in which fluid leaks into the lungs, making breathing difficult or impossible – and can lead to multi-organ failure and sometimes death.1,2
"Our collaboration with Mallinckrodt to study high-dose inhaled nitric oxide to treat patients with COVID-19 and associated lung complications is an exciting step in both companies' commitment to helping the world battle this global pandemic," said Alex Stenzler, Founder and President at Novoteris.
Inhaled nitric oxide (iNO) has been evaluated in randomized controlled trials, both in pediatric and adult patients with ARDS,3,4,5,6,7 and demonstrated partially dose-dependent improvement in blood oxygenation and decreased pulmonary artery pressure3 and, in one trial, improvements in the composite measure of days alive or free of ventilator support at day 28 of the trial (the last day evaluated).8 There have been other trials evaluating iNO in the context of ARDS, which have demonstrated mixed results.6,7,9 In an in vitro study, inhaled nitric oxide has demonstrated an inhibitory effect on the replication cycle of severe acute respiratory syndrome-related coronavirus (SARS-CoV).10 Furthermore, a small clinical trial in SARS-CoV patients demonstrated improvements in blood oxygenation, a reduction in supplemental oxygen and a reduction in the amount of ventilator support.11
"This is an important day for patients and healthcare providers," said Chris Miller, Ph.D., Assistant Professor, Faculty of Medicine at University of British Columbia and Founder and Scientific Advisor at Novoteris. Dr. Miller, team lead for the study at Vancouver Coastal Health Research Institute, and an expert in nitric oxide therapies, with a research career spanning more than 25 years studying the antimicrobial effect of high-dose nitric oxide to treat lung infections, said, "I am very pleased to be working with Mallinckrodt and Novoteris on this study using high-dose inhaled nitric oxide for patients with COVID-19."
Mallinckrodt is currently working with the U.S. Food and Drug Administration on the possibility of making the company's INOmax® (nitric oxide) gas, for inhalation product available to U.S. patients with pulmonary complications of COVID-19 as quickly as possible through the appropriate regulatory mechanism. INOmax has been on the market in the U.S. since 2000, and is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Please see Important Safety Information below. The safety and efficacy of INOmax and iNO for pulmonary complications associated with COVID-19 have not been established.
For more information, please visit clinicaltrials.gov.
Canada – Indications and Important Safety Information
INDICATIONS & CLINICAL USE
INOmax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and late pre-term (≥ 34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
The safety and effectiveness of INOmax have been established in a population receiving other therapies for hypoxic respiratory failure, including vasodilators, intravenous fluids, bicarbonate therapy, and mechanical ventilation.
In clinical trials, no efficacy has been demonstrated with the use of INOmax in patients with congenital diaphragmatic hernia.
CONTRAINDICATIONS
In patients where systemic oxygenation is wholly dependent on extra-pulmonary right-to-left shunting, use of INOmax has the potential to decrease right-to-left blood flow, which, in this condition, is potentially fatal.
MOST SERIOUS WARNINGS & PRECAUTIONS
Left-to-Right Shunting: Treatment might aggravate cardiac insufficiency due to unwanted pulmonary vasodilation caused by inhaled nitric oxide, resulting in a further increase of already existing pulmonary hyperperfusion. It is recommended to perform pulmonary artery catheterization or echocardiographic examination of central hemodynamics prior to administration.
OTHER RELEVANT WARNINGS & PRECAUTIONS
If clinical response is inadequate at 4-6 hours after starting INOmax: availability of nitric oxide on transport to another hospital should be assured to prevent worsening of condition on acute discontinuation of INOmax. Rescue, such as ECMO, should be considered on continued deterioration or failure to improve, defined by local hospital criteria.
INOmax should not be discontinued abruptly as it may result in rebound pulmonary hypertension. If rebound pulmonary hypertension occurs, reinstate therapy immediately.
Neonates are known to have diminished methemoglobin reductase activity and could be at greater risk of developing methemoglobinemia.
NO2 rapidly forms in gas mixtures containing nitric oxide and O2, and nitric oxide may in this way cause airway inflammation and damage.
Patients with left ventricular dysfunction treated with inhaled nitric oxide, experienced serious adverse events. Discontinue INOmax while providing symptomatic care.
Animal models have shown that nitric oxide may interact with homeostasis, resulting in an increased bleeding time. Data in adult humans are conflicting.
For more information please consult the product monograph at https://www.mallinckrodt.ca/wp-content/uploads/...oduct-Monograph.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The product monograph is also available by calling us at 1-855-399-6742.
U.S. – Indications and Important Safety Information
INDICATION
INOmax® (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
IMPORTANT SAFETY INFORMATION
INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation.
Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema.
Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration.
INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System.
Please see Full Prescribing Information.
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
ABOUT NOVOTERIS, LLC
Novoteris, LLC is a privately held limited liability company managed by a group of international industry veterans and clinicians involved in developing and producing innovative, cutting-edge medical products. The company was formed in 2013 to consolidate the nitric oxide assets and other resources from 12th Man Technologies, Inc. (Garden Grove, CA) and Nitric Solutions, Inc. (Vancouver, Canada) for the completion of inhaled nitric oxide trials for the treatment of patients with cystic fibrosis. The company received Orphan Drug designations for the treatment of cystic fibrosis from both the FDA and EMA in 2013. Novoteris is headquartered in Garden Grove, California with an EU entity in Belgium (Novoteris GVC). For additional information, please visit www.novoteris.com.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning inhaled nitric oxide ("iNO") and Mallinckrodt's INOmax product, including statements with regard to potential regulatory developments, the potential impact of iNO on patients and anticipated benefits associated with its use, as well as statements related to COVID-19. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: clinical trial results; the impact of the outbreak of the COVID-19 coronavirus; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
CONTACTS
For Trade Media Inquiries
Caren Begun
Green Room Communications
201-396-8551
caren@greenroompr.com
Alex Stenzler
President, Novoteris, LLC
714-705-4576
alex.stenzler@12thmantec.com
Stephania Manusha
Director, Clinical Trials Administration
Vancouver Coastal Health & Research Center
604.675.2567
stephania.manusha@vch.ca
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Government Affairs
Mark Tyndall
Senior Vice President, Government Affairs
202-383-0090
mark.tyndall@mnk.com
USL6233LAB29
Fälligkeit am 15.April. Wird er bezahlt sind wir über 3 Dollar.....wenn nicht........
Gehe davon aus, das er bezahlt wird, aber bin mir nicht sicher ob "normal" da wären die Bondholder die grossen Gewinner oder Trudeau lässt das DIng platzen und "winkt" mit Konkurs bis die Bondholder zustimmen und dieser Bond mit 50-80% ausbezahlt wird.
Fraglich ist auch, ob MNK von einem Corovid Anleihehilfsprogramm von FED oder EZB partizipieren kann. Da könnte Trudeau auch mit spielen.
Washington braucht bestimmt keinen Konkurs von MNK in den Nachrichten.
Wenn die FED Boeing mit über 10 Milliarden im Aktienkurs stützen kann - warum nicht mit MNK mit einer Bürgschaft oder Anleiheankauf über 1 Milliarde?
Denke zur HV im Mai kommt einiges
https://newsfilter.io/a/194379887be9d06791789b5622a7f84a
Könnte hier durchaus Umsatz- und Gewinnsprünge geben.
https://seekingalpha.com/news/...eed_news_all&utm_medium=referral
Da der Kurs bisher kräftig gestiegen ist, bin ich zuversichtlich auf eine positive Meldung. Shortquote immer noch enorm hoch.
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Exchange Agreement
On April 7, 2020, Mallinckrodt plc (the Company or Mallinckrodt) and Mallinckrodt International Finance S.A. and Mallinckrodt CB LLC, two
wholly-owned subsidiaries of Mallinckrodt plc (such subsidiaries, the Issuers, and together with the Company, the Mallinckrodt Parties), entered into
an exchange agreement (the Exchange Agreement) with Aurelius Capital Master, Ltd., Franklin Advisers, Inc., as investment manager to certain funds
Exchanging Holders). Pursuant to the Exchange Agreement, the Exchanging Holders agreed to a private exchange with the Issuers of their holdings of
4.875% Senior Notes due 2020 issued by the Issuers (the Existing Notes) (consisting of approximately $495.0 million aggregate principal amount of the
Existing Notes) for new 10.000% First Lien Senior Secured Notes due 2025 issued by the Issuers (the New Notes), at a rate of $1,000 of New Notes for
every $1,000 of Existing Notes exchanged (such exchange, the Exchange). The Issuers and Exchanging Holders expect to consummate the Exchange on
April 7, 2020.
as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Indenture
The New Notes being issued in the Exchange are to be issued pursuant to an indenture dated as of April 7, 2020 (the Indenture) among the Issuers, the
Note Guarantors (as defined below), Wilmington Savings Fund Society, FSB, as first lien trustee, and Deutsche Bank AG New York Branch, as first lien
collateral agent.
Interest on the New Notes is payable semi-annually in cash on April 15 and October 15 of each year, commencing on October 15, 2020.
the New Notes on or after April 15, 2022 at specified redemption prices. In addition, prior to April 15, 2022, the Issuers may redeem up to 40% of the
aggregate principal amount of the New Notes with the net proceeds of certain equity offerings. The Issuers may also redeem all, but not less than all, of the
New Notes at any time at a price of 100% of their principal amount, plus accrued and unpaid interest, if any, in the event the Issuers become obligated to
pay additional amounts as a result of changes affecting certain withholding tax laws applicable to payments on the New Notes.
result of certain change of control events and (b) at a price of 100% of their principal amount plus accrued and unpaid interest, if any, in the event of certain
net asset sales. These obligations are subject to certain qualifications and exceptions.
The Indenture contains certain customary covenants and events of default (subject in certain cases to customary grace and cure periods). The occurrence of
an event of default under the Indenture could result in the acceleration of the New Notes and could cause a cross-default that could result in the acceleration
of other indebtedness of the Company and its subsidiaries.
The New Notes are jointly and severally guaranteed, subject to certain exceptions (including the exclusion of any subsidiary organized under the laws of
Switzerland), on a secured, unsubordinated basis by the Company and each of its subsidiaries (other than the Issuers) (the Note Guarantors) that
guarantees the obligations under the Issuers existing senior secured credit facilities.
The New Notes and the guarantees thereof are secured by liens on the same assets of the Issuers and the Note Guarantors that are subject to liens securing
the existing senior secured credit facilities, subject to certain exceptions (including the exclusion of the assets of any subsidiary organized under the laws of
Switzerland).
The foregoing summary of the Indenture is not complete and is qualified in its entirety by reference to the Indenture, which is filed as Exhibit 4.1 to this
Current Report on Form 8-K and incorporated herein by reference.
Item 1.02. Termination of a Material Definitive Agreement.
Under the terms of the Exchange Agreement, the Mallinckrodt Parties, Aurelius Capital Master, Ltd., Franklin Advisers, Inc. Capital Research and
Management Company agreed to terminate the Support and Exchange Agreement, dated as of February 25, 2020, by and among them, effective as of April
7, 2020.
Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of
a Registrant.
The information set forth in Item 1.01 of this Current Report on Form 8-K i
Also irgend etwas positives sollte da im Busch sein.