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June 1, 2014
13:07 EDTARIAARIAD presents updated Phase 1/2 data on AP26113
ARIAD Pharmaceuticals announced updated clinical results on its investigational tyrosine kinase inhibitor, TKI, AP26113, in patients with advanced non-small cell lung cancer, NSCLC, from an ongoing Phase 1/2 trial. These study results show anti-tumor activity of AP26113 in patients with crizotinib-resistant anaplastic lymphoma kinase, ALK, positive NSCLC, including patients with brain metastases. Crizotinib is approved for ALK-positive NSCLC patients. The updated Phase 1/2 results are being presented at the 2014 American Society of Clinical Oncology, ASCO, annual meeting in Chicago. “The data from the Phase 2 portion of the trial show that AP26113 exhibits anti-tumor activity in patients with crizotinib-resistant ALK rearranged NSCLC, as well as crizotinib-naïve ALK rearranged NSCLC,” stated Scott N. Gettinger, M.D., associate professor of medicine at Yale School of Medicine. “Importantly, AP26113 demonstrates activity against brain metastases in patients with prior crizotinib therapy, including responses of clinically meaningful duration.”
News For ARIA From The Last 14 Days
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July 23, 2014
18:34 EDTARIAOn The Fly: After Hours Movers
UP AFTER EARNINGS: Fortinet (FTNT), up 7.8%... Hanesbrands (HBI), up 5.4%... 8x8 (EGHT), up 5.1%... Infinera (INFN), up 4.9%... Facebook (FB), reverses and is now trading up 5.1% following second quarter earnings conference call. NOTABLE: Twitter (TWTR), up 1.7%, LinkedIn (LNKD), up marginally, and Yelp (YELP), up 1.6% after Facebook reports second quarter results. ALSO HIGHER: Spectranetics (SPNC), up 7.1% after receiving FDA clearance for atherectomy products, Turbo-Tandem and Turbo Elite... Ariad Pharmaceuticals (ARIA), up 7.1%... Jamba (JMBA), up 3.8% after Engaged Capital reports stake in the company and announced that they had discussions with management. DOWN AFTER EARNINGS: AT&T (T), down 1.2%... Angie's List (ANGI), down 16.4%... Tripadvisor (TRIP), down 11.5%... Orchids Paper (TIS), down 7.4%... Cirrus Logic (CRUS), down 6.6%... Cliffs Natural (CLF), down 1.2%... Teradyne (TER), down 4%. ALSO LOWER: Kandi Technologies (KNDI), down 3.8% after being mentioned negatively in a Seeking Alpha blog post.
13:59 EDTARIAARIAD rises 11.8% to $5.70
July 14, 2014
07:37 EDTARIAARIAD announces continuation of Iclusig review under Article 20 procedure
ARIAD Pharmaceuticals announced that the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has provided the company with a request for limited additional information regarding Iclusig as part of its ongoing review under the Article 20 referral procedure. The PRAC has requested further information regarding proposed dose modifications after achievement of a response and patient monitoring and details concerning a risk management plan. Following ARIAD’s response and input from the agency’s Scientific Advisory Group, the company expects that the PRAC will complete its review and make final recommendations to the Committee for Medicinal Products for Human Use at its meeting in October. As we finalize our recommendations on dose modifications of Iclusig and response monitoring of patients, we will work closely with the European regulatory agency and its expert advisors so that CML patients and their treating physicians have the best guidance available supporting the appropriate use of Iclusig,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. In March ARIAD submitted responses to initial questions outlined by the PRAC as part of the Article 20 process, which was initiated in December of last year, and responses to a second set of questions were submitted to the PRAC in June.
July 10, 2014
13:25 EDTARIAARIAD mentioned positively by Stansberry Research
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