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June 16, 2014
08:04 EDTLGNDLigand says LGD-6972 well-tolerated in Phase 1 study
Ligand Pharmaceuticals announced data from a Phase 1 clinical trial with LGD-6972 that demonstrate favorable safety, tolerability and pharmacokinetics in normal healthy volunteers and in subjects with type 2 diabetes mellitus, and also demonstrate a robust response on fasting plasma glucose after a single dose. LGD-6972 is Ligandís novel glucagon receptor antagonist and these first-in-human data were presented at the American Diabetes Associationís 74th Scientific Sessions meeting underway in San Francisco. Highlights of the single-ascending dose trial involving a total of 56 subjects include: LGD-6972 was well-tolerated; there were no clinically significant or dose-dependent changes in hematology, clinical chemistry, urinalysis, ECG or vital signs, and no serious adverse events. LGD-6972 was well-absorbed after oral administration; peak plasma concentrations were reached approximately 5 to 8 hours post dose with a long elimination half-life of approximately 50 hours, supporting once-daily dosing. After a single dose, LGD-6972 reduced fasting plasma glucose in normal healthy volunteers and in subjects with type 2 diabetes. Fasting plasma glucose was reduced by 57 mg/dL in subjects with type 2 diabetes, suggesting a robust response in this acute study.
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July 31, 2015
08:52 EDTLGNDAmgen results highlight Ligand royalty strength, says Roth Capital
Roth Capital notes Amgen (AMGN) reported Q2 Kyprolis sales of $119M compared to its estimate of $117M. The drug, alongside Promacta, represent the majority of Ligand's current royalty stream, the firm tells investors. It believes the growth of Kyprolis highlights Ligand's "strong core royalty bearing asset lineup." Roth keeps a Buy rating on the stock with a $135 price target.
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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