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Stock Market & Financial Investment News

News Breaks
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.
News For ARIA From The Last 14 Days
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December 11, 2014
10:13 EDTARIAOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: ARIAD (ARIA) downgraded at Credit Suisse... AbbVie (ABBV) downgraded to Equal Weight from Overweight at Morgan Stanley... Aimco (AIV) downgraded to Hold from Buy at KeyBanc... Anglo American (AAUKY) downgraded to Underperform from Neutral at Exane BNP Paribas... Approach Resources (AREX) downgraded at Sterne Agee... CommVault (CVLT) downgraded to Neutral from Outperform at Macquarie... Fifth Street Senior (FSFR) downgraded to Perform from Outperform at Oppenheimer... Harmonic (HLIT) downgraded to Neutral from Buy at Sidoti... Macerich (MAC) downgraded to Hold from Buy at Deutsche Bank... Newell Rubbermaid (NWL) downgraded to Outperform from Strong Buy at Raymond James... Olin Corp. (OLN) downgraded at Longbow... Penn West (PWE) downgraded to Underperform from Neutral at BofA/Merrill... Prudential plc (PUK) downgraded to Neutral from Buy at Nomura... Semiconductor Manufacturing (SMI) downgraded to Hold from Buy at Jefferies... Suncor (SU) downgraded to Neutral from Buy at BofA/Merrill... Talisman Energy (TLM) downgraded to Underperform from Neutral at BofA/Merrill... Thompson Creek (TC) downgraded to Hold from Buy at Deutsche Bank... Toll Brothers (TOL) downgraded to Underperform from Sector Perform at RBC Capital... Travelers (TRV) downgraded to Neutral from Buy at UBS... United Therapeutics (UTHR) downgraded at Credit Suisse... Vera Bradley (VRA) downgraded to Underperform from Neutral at Sterne Agee.
09:16 EDTARIAOn The Fly: Pre-market Movers
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08:02 EDTARIAARIAD downgraded at Credit Suisse
As previously reported, Credit Suisse downgraded ARIAD to Underperform from Neutral. The firm said Iclusig launch metrics are weak and expects it to remain a last option for CML patients with specific resistant mutations or failure with other therapies. Price target lowered to $6 from $8.
06:14 EDTARIAARIAD downgraded to Underperform from Neutral at Credit Suisse
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December 9, 2014
09:10 EDTARIAARIAD takeover rumors rekindled, Independent says
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07:37 EDTARIAARIAD announces safety, efficacy follow-up data on Iclusig
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07:36 EDTARIAARIAD says Iclusig shows anti-leukemic activity in long-term follow up data
ARIAD Pharmaceuticals announced long-term follow up data from the Phase 1 trial of Iclusig, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. The study now shows that with a median follow-up of four years in chronic phase CML patients, Iclusig continues to demonstrate anti-leukemic activity in patients with limited treatment options and that responses have been maintained in CP-CML patients with 72 percent having a major cytogenetic response, 65 percent having a complete cytogenetic response and 56 percent having a major molecular response. Long-term safety data show that careful benefit-risk evaluations should guide decisions to use and maintain ponatinib therapy, particularly in patients who may be at increased risk for arterial thrombotic events. These data were featured in a poster presentation on December 8 at the 56th Annual Meeting of the American Society of Hematology taking place in San Francisco.
December 8, 2014
07:36 EDTARIAARIAD: Iclusig demonstrates anti-leukemic activity in patents in Phase 2 trial
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