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June 13, 2014
07:32 EDTLGNDLigand says Phase 3 PETIT2 study met primary endpoint
Ligand Pharmaceuticals (LGND) announces that its partner, GlaxoSmithKline (GSK), presented the results from the Phase 3 PETIT2 study evaluating the efficacy of eltrombopag vs. placebo in pediatric patients with chronic immune thrombocytopenic purpura. Eltrombopag - marketed as Promacta in the U.S. and as Revolade in Europe and other countries across the world - met its primary endpoint, achieving a statistically significant improvement in platelet counts with almost 40% of patients treated with eltrombopag attaining a consistent platelet response for 6 of 8 weeks compared to placebo. The PETIT2 study results were highlighted today as part of a Press Briefing and Oral Presentation at the European Hematology Association Annual Congress in Milan, Italy. GSK also announced that it is moving forward with planned regulatory submissions for a pediatric indication in cITP later this year. Efficacy results for PETIT2 were consistent across age cohorts. The safety profile was consistent with the established profile for eltrombopag and no new safety concerns were observed. The most common adverse events occurring most frequently in the eltrombopag arm included nasopharyngitis, rhinitis, cough and respiratory tract infection. Grade 3/4 AEs occurred in 12.7% of patients treated with eltrombopag and 10.3% of patients in the placebo group. Serious AEs were reported in 8% of eltrombopag-treated patients vs. 14% in the placebo arm. Additional results from an early phase study of eltrombopag in previously treated pediatric patients with cITP were also presented at the European Hematology Association Annual Congress.
News For LGND From The Last 14 Days
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July 30, 2015
09:01 EDTLGNDLigand enters license, supply agreement with Sanofi
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July 24, 2015
12:44 EDTLGNDAmgen announces FDA approval of expanded Kyprolis indication
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12:27 EDTLGNDFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
09:02 EDTLGNDLigand says Revolade recommended by CHMP for EU approval for SAA
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