Ariad Pharma on the Top

ich bin der Meinung besser ist es Ariad selber voran zubringen.Kann zwar was dauern,aber wenn jetzt ein Buyout kommen würde,würde vielleicht ein Aufschlag von 20-30 Prozent vom jetzigen kurz kommen.Heisst wenn ich von 6,80 ausgehen darf und 30 prozent nehmen würde, dann würden mann ein Buyout von gerade mal 8,84$ sehen.Bei 50 Prozent wären es 10,20$ also nicht gerade befriedigend oder ??  

 

oder ich muß meinen Bildschirm drehen...  

Nartürlich.Iclusig macht derzeit nicht genug Gewinn.Die anderen Sachen ohne diese jetzt wieder alle aufzählen zu müssen,bringen noch weniger.Demnach wäre ein Aufschlag von 30-50 Prozent mehr als Fair.Darum ist ein Bugout derzeit nicht das was Berger und Denen anstreben werden.Bei Kursen um 20-30 Doller könnte ich mir gut vorstellen das ein Bugout in Richtung 44-48 Doller die Aktie kommen kann.Vorher glaube ich nicht.
PS.Fraglich ob Sie überhaupt so hoch gehen wird.Nicht das einige jetzt denken naja 25 Doller reichen mir auch schon ;-)  

 

Meines Erachtens befindet sich die Aktie momentan in der übergeordneten Impulsbewegung 3, jedoch korrigiert sie als Triangle innerhalb dieser Aufwärtsbewegung.  Die Korrekturformation Triangle besteht aus fünf Wellen:
        a)§16.12. = 6.08 $
        b)§19.12. = 7,22 $
        c)§23.12. = 6,66 $
        d)§26.12. = 7,09 $
        e)§30.12. = 6,815 $
Wichtig jedoch ist lediglich, dass die miteinander verbundenen Hochpunkte ebenso wie die Tiefpunkte der Wellen der Triangle-Korrekturformation zusammen eine einheitliche Begrenzungslinie ausbilden. Hier ist dann erhöhte Aufmerksamkeit geboten, denn die sich daran anschließende Impulswelle kann plötzlich beginnen!
Prognose für heute: Schlusskurs zwischen 6,82 $ (im schlechtesten Fall) bis 7,08 $ (im guten Fall). Jeder Kurs darüber müsste eigentlich für ein Kursfeuerwerk sorgen, denn damit würde die bereits angefangene Impulsbewegung (Unterwelle 1 abgeschlossen, Unterwelle 2 (Korrekturwelle) hoffentlich abgeschlossen) ihren Fortgang mit der Unterwelle 3 finden. Kursziel wie bereits geschrieben: 10,03 $
Good trades
T-Rexi
 

das beste Tool, um Ariad zu "bewerten". Um die Chemie/Pharmazie muss man sich keine Sorgen machen, die wirkt und funktioniert bei Ariad. Langfristig immer noch top, meines Erachtens.

Ich wünsche Euch einen guten Rutsch ins Neue Jahr.  

im Trend wieder leicht nach oben.  

Jahr und viel Glück 2015 Allen  

euch allen ein Erfolgreiches und vor allem Gesundes neues Jahr...
Und es geht im neuen Jahr weiter wie es im alten aufgehört hat denn wie wir sehen ist die Tür zum Keller wieder weit offen mit 0.19€ im Minus...  

Ami Start? Umgerechnet müssten wir hier bei 5,70€ stehen.
Glück für die, die am Vormittag billig eingekauft haben. :)  

 

http://www.pharma-zeitung.de/...ngsabkommen-fur-iclusig-in-s.7094.php

Jeder zusätzliche Vertriebsweg bringt Kohle rein und macht das unternehmen bekannter und lukrativer.  

wissen wir also jetzt schon in welche Richtung es morgen gehen wird...:-)  

Saturday, January 3, 2015

AP26113 Approval could come at any time based on existing data
Short Version of the Story: Ceritinib received FDA Approval based Phase One Trail data that was inferior to AP26113 Phase I/II data. As such, FDA approval for AP26113 could come at any moment, and the FDA might not wait for results from the Alta Phase II trial (for which recruitment is now underway).

Long Version of Story...

First of all, things can move quickly. Let's take the Ceritinib, which received FDA Approval based on PHASE ONE trail data. Here's the language about that data.

In April 2014, the next-generation ALK inhibitor ceritinib received an accelerated approval as a treatment for patients with ALK-positive NSCLC following progression on crizotinib. This approval was based on phase I data from the ASCEND-1 trial showing an overall response rate (ORR) of 58.5%. The early median duration of response was near 7.5 months - See more at: http://www.onclive.com/peer-exchange/nsclc-needs/...ash.g9PjxxjH.dpuf Source

Now, let's compare that to the AP26113 Phase I/II Trial Data Results (and note it's phase I/II, not just phase I):

The objective response rate (The objective response rate (ORR) in 72 evaluable patients with ALK-positive NSCLC was 72%. The median duration of response was 49 weeks. The median progression-free survival (PFS) was 56 weeks. In the 65 evaluable patients treated with prior crizotinib, the ORR was 69% with a median PFS of 47.3 weeks. In 7 evaluable patients with treatment-naïve ALK-positive NSCLC, AP26113 demonstrated 2 complete and 5 partial responses, for an ORR of 100%. In patients with untreated or progressing brain metastases (n = 14), 71% of patients had evidence of radiographic disease improvement. - See more at link

Now, you do the math. AP26113 has better clinical data than a drug that the FDA recently approved based on Phase I Clinical Data.

The punch line is that AP26113 Approval could come at any time.

http://ariad-investors-home.blogspot.com/  

haelt sich eigentlich gut, bei dem Gesamtmarkt.  

Ruhe vor dem Sturm ist (mit Blick auf den 14.01)!  

 

ARIAD Announces Phase 2 Dose-Ranging Trial of Iclusig (Ponatinib) to Begin by Mid-2015

Randomized Global Trial to Evaluate Safety and Efficacy of Iclusig at Three Starting Doses

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 6, 2015-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it has concluded consultations with U.S. and European health authorities regarding the design of a randomized, dose-ranging trial to evaluate three starting doses of Iclusig® (ponatinib) in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML). The trial is expected to inform the optimal use of Iclusig in these patients and will begin by mid-2015. Approximately 450 patients will be enrolled at clinical sites around the world.

“This clinical trial is expected to provide important data regarding the efficacy of Iclusig treatment initiating at doses less than the currently approved starting dose and maintaining patients on a lower dose. We expect that this will better characterize the safety profile of Iclusig beginning at lower doses,” said Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD. “We also anticipate that this trial will give us the opportunity to further explore strategies for dose reductions after patients have achieved a major cytogenetic response in order to maximize an individual’s benefit/risk while on therapy.”

Major Design Features of the Trial

This study will enroll patients with CP-CML who are resistant to at least two approved tyrosine kinase inhibitors. These patients will be randomized equally to receive once-daily administration of 45 mg (cohort A), 30 mg (cohort B) or 15 mg (cohort C) of Iclusig. Patients in cohorts A and B will have their daily dose reduced to 15 mg upon achievement of major cytogenetic response (MCyR).

The primary endpoint of the trial is MCyR by 12 months for each cohort. Secondary endpoints include rate of vascular occlusive events in each dose cohort, rates of adverse events and rates of serious adverse events. Other secondary endpoints include cytogenetic, molecular and hematologic response rates, tolerability, duration of response, time to response, disease control rate, progression-free survival and overall survival.

Interim reports will be submitted to the U.S. Food and Drug Administration and the European Medicines Agency, providing an opportunity to review safety and efficacy data collected during the trial. Patients will be enrolled at up to 90 cancer centers globally. For more information about the trial, patients and physicians should call the U.S. toll-free number 855-552-7423, the EU toll-free number 800 00027423, or the international number +1 617-503-7423, or email ARIAD at ClinicalTrials@ariad.com.

About Iclusig® (ponatinib) tablets

Iclusig is approved in the U.S., EU, Australia and Switzerland.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

   Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
   Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

   Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
   Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
   Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Vascular Occlusion: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in at least 27% of Iclusig-treated patients from the phase 1 and phase 2 trials. Iclusig can also cause recurrent or multi-site vascular occlusion. Overall, 20% of Iclusig-treated patients experienced an arterial occlusion and thrombosis event of any grade. Fatal and life-threatening vascular occlusion has occurred within 2 weeks of starting Iclusig treatment and in patients treated with average daily dose intensities as low as 15 mg per day. The median time to onset of the first vascular occlusion event was 5 months. Patients with and without cardiovascular risk factors have experienced vascular occlusion although these events were more frequent with increasing age and in patients with prior history of ischemia, hypertension, diabetes, or hyperlipidemia. Interrupt or stop Iclusig immediately in patients who develop vascular occlusion events.

Heart Failure: Fatal and serious heart failure or left ventricular dysfunction occurred in 5% of Iclusig-treated patients (22/449). Eight percent of patients (35/449) experienced any grade of heart failure or left ventricular dysfunction. Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation of Iclusig in patients who develop serious heart failure.

Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in an Iclusig-treated patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with blast phase CML (BP-CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Severe hepatotoxicity occurred in all disease cohorts. Iclusig treatment may result in elevation in ALT, AST, or both. Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, reduce or discontinue Iclusig as clinically indicated.

Hypertension: Treatment-emergent hypertension (defined as systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg on at least one occasion) occurred in 67% of patients (300/449). Eight patients treated with Iclusig (2%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including one patient (<1%) with hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In 131 patients with Stage 1 hypertension at baseline, 61% (80/131) developed Stage 2 hypertension. Monitor and manage blood pressure elevations during Iclusig use and treat hypertension to normalize blood pressure. Interrupt, dose reduce, or stop Iclusig if hypertension is not medically controlled.

Pancreatitis: Clinical pancreatitis occurred in 6% (28/449) of patients (5% Grade 3) treated with Iclusig. Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (25/449). The incidence of treatment-emergent lipase elevation was 41%. Check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Consider additional serum lipase monitoring in patients with a history of pancreatitis or alcohol abuse. Dose interruption or reduction may be required. In cases where lipase elevations are accompanied by abdominal symptoms, interrupt treatment with Iclusig and evaluate patients for pancreatitis. Do not consider restarting Iclusig until patients have complete resolution of symptoms and lipase levels are less than 1.5 x ULN.

Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 13% (59/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). In clinical trials, the most common peripheral neuropathies reported were peripheral neuropathy (4%, 18/449), paresthesia (4%, 17/449), hypoesthesia (2%, 11/449), and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 1% (6/449) of Iclusig-treated patients (<1% grade 3/4). Of the patients who developed neuropathy, 31% (20/65) developed neuropathy during the first month of treatment. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Consider interrupting Iclusig and evaluate if neuropathy is suspected.

Ocular Toxicity: Serious ocular toxicities leading to blindness or blurred vision have occurred in Iclusig-treated patients. Retinal toxicities including macular edema, retinal vein occlusion, and retinal hemorrhage occurred in 3% of Iclusig-treated patients. Conjunctival or corneal irritation, dry eye, or eye pain occurred in 13% of patients. Visual blurring occurred in 6% of the patients. Other ocular toxicities include cataracts, glaucoma, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.

Hemorrhage: Serious bleeding events, including fatalities, occurred in 5% (22/449) of patients treated with Iclusig. Hemorrhagic events occurred in 24% of patients. The incidence of serious bleeding events was higher in patients with accelerated phase CML (AP-CML), BP-CML, and Ph+ ALL. Most hemorrhagic events, but not all occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and evaluate.

Fluid Retention: Serious fluid retention events occurred in 3% (13/449) of patients treated with Iclusig. One instance of brain edema was fatal. In total, fluid retention occurred in 23% of the patients. The most common fluid retention events were peripheral edema (16%), pleural effusion (7%), and pericardial effusion (3%). Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated.

Cardiac Arrhythmias: Symptomatic bradyarrhythmias that led to a requirement for pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients. Advise patients to report signs and symptoms suggestive of slow heart rate (fainting, dizziness, or chest pain). Supraventricular tachyarrhythmias occurred in 5% (25/449) of Iclusig-treated patients. Atrial fibrillation was the most common supraventricular tachyarrhythmia and occurred in 20 patients. For 13 patients, the event led to hospitalization. Advise patients to report signs and symptoms of rapid heart rate (palpitations, dizziness). Interrupt Iclusig and evaluate.

Myelosuppression: Severe (grade 3 or 4) myelosuppression occurred in 48% (215/449) of patients treated with Iclusig. The incidence of these events was greater in patients with AP-CML, BP-CML and Ph+ ALL than in patients with CP-CML. Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically indicated, and adjust the dose as recommended.

Tumor Lysis Syndrome: Two patients (<1%) with advanced disease (AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (30/449) of patients overall; the majority had CP-CML (19 patients). Due to the potential for tumor lysis syndrome in patients with advanced disease, ensure adequate hydration and treat high uric acid levels prior to initiating therapy with Iclusig.

Compromised Wound Healing and Gastrointestinal Perforation: Since Iclusig may compromise wound healing, interrupt Iclusig for at least 1 week prior to major surgery. Serious gastrointestinal perforation (fistula) occurred in one patient 38 days post-cholecystectomy.

Embryo-Fetal Toxicity: Iclusig can cause fetal harm. If Iclusig is used during pregnancy, or if the patient becomes pregnant while taking Iclusig, the patient should be apprised of the potential hazard to the fetus. Advise women to avoid pregnancy while taking Iclusig.

Most common non-hematologic adverse reactions: (≥20%) were hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, arthralgia, nausea, and pyrexia. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

About ARIAD

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).

This press release contains “forward-looking statements” including, but not limited to, statements relating to an upcoming dose-ranging study for ponatinib and its potential to further explore dose reduction strategies after patients have achieved a major cytogenetic response. Forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies, the costs associated with our research, development, manufacturing and other activities, the enrollment, conduct, timing and results of pre-clinical and clinical studies of our product candidates, the adequacy of our capital resources and the availability of additional funding, and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.

Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc.

Source: ARIAD Pharmaceuticals, Inc.

ARIAD Pharmaceuticals
For Investors
Kendra Adams, 617-503-7028
Kendra.adams@ariad.com
or
For Media
Liza Heapes, 617-620-4888
Liza.heapes@ariad.com  

http://investor.ariad.com/...22&p=irol-newsArticle&ID=2003428  

und wie immer danach ab mit dem Fahrstuhl in den Keller....
 

J.P. Morgan Comments On Ariad Pharmaceuticals Following Update On Iclusig Trial Design

The analyst rates the stock a Neutral with an $8 price target.

Vollständige Artikel von heute: http://www.smarteranalyst.com/2015/01/06/...ate-iclusig-trial-design/  

gestern -6 heute krepelt es mühselig bei +1,5 rum.. ist ja net mit anzusehen, das ding soll mal aus dem popo kommen! $6.80 sollte mal zügig zurückerobert werden..  

 

saw a story on local Chicago news about a life-saving cancer drug and an interview with a woman with lung cancer and how her life is being saved by this cancer-genome targeted therapy. They kept showing a bottle of pills with ARIAD label. I guess it was AP26113. looks good

http://finance.yahoo.com/mbview/threadview/...f&mbtc=mb-tab-topic

Ohne Gewähr!