New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 18, 2013
07:09 EDTSPPI, LGNDLigand Pharmaceuticals deal positive, says Cantor
After Ligand Pharmaceuticals (LGND) announced a license and global supply agreement with Spectrum Pharmaceuticals (SSPI) on Captisol-enabled Melphalan for the treatment of multiple myeloma, Cantor believes the deal is "attractive" for Ligand. The firm, which maintains a Hold rating on Ligand, indicates that it is close to upgrading the stock, but is not doing so because it is still concerned about the company's Promacta generic filer announcement.
News For LGND;SPPI From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
September 2, 2015
12:09 EDTSPPISpectrum drops after activist cuts stake to 1.5%
Subscribe for More Information
07:05 EDTSPPISpectrum annoubces publication of Evomela for injection data
Spectrum Pharmaceuticals announced publication of results from the pivotal clinical study for EVOMELA, used for myeloablative conditioning in multiple myeloma patients undergoing autologous transplantation. The study, led by Dr. Parameswaran Hari from Froedtert Hospital and Medical College of Wisconsin, was published in the Biology of Blood and Marrow Transplantation journal. The BBMT journal publication includes data on 61 patients who were enrolled in this open-label Phase 2b pivotal study at five US study sites; 56 patients had newly diagnosed disease and five had relapsed MM following prior ASCT. Patients enrolled in this study received 200 mg/m2 of EVOMELA as two doses on Day -3 and Day -2 prior to ASCT. Efficacy was assessed by clinical response at Day +100 with an ORR of 95% and CR rate of 31% based on investigators' assessments, and rates of 100% and 21%, respectively based on independent pathology review; the lower rate of confirmed CRs in the independent review was due to missing data. Importantly, the five patients who had previously relapsed from a prior ASCT were all shown to achieve a response to EVOMELA. All patients in the study achieved myeloablation with a median of 5 days post-ASCT, and all patients had successful neutrophil and platelet engraftment. Treatment-related mortality was 0%, and non-hematologic adverse events were mostly Grade 1 and Grade 2 in severity. The incidence of Grade 3 mucositis and Grade 3 stomatitis were 10% and 5%, respectively with no Grade 4 mucositis or stomatitis reported. Twenty percent of patients experienced treatment-emergent serious adverse events, most of which were Grade 3, and consisted of events commonly reported in patients undergoing myeloablative chemotherapy; no new safety signals were identified.
August 24, 2015
13:15 EDTLGNDFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use