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June 13, 2014
08:04 EDTCELG, AGIOAgios says Celgene exercised option to license AG-221
Agios Pharmaceuticals (AGIO) announced that its partner Celgene (CELG) has exercised its option to an exclusive worldwide license to AG-221, an oral, first-in-class, potent inhibitor of the mutant IDH2 protein. Under the terms of the agreement, the option to license extended to Celgene through the end of Phase 1, but AG-221 has been exercised early based on the Phase 1 data generated to date. AG-221 is currently in a Phase 1 dose escalation study in patients that harbor an IDH2 mutation with advanced hematologic malignancies, including acute myeloid leukemia. Agios and Celgene entered into a global strategic collaboration in April 2010 to develop new therapeutics targeting cancer metabolism. By exercising its exclusive option under the terms of the agreement, Celgene gains worldwide development and commercialization rights for AG-221. Agios, in addition to contributing its scientific and translational expertise, will continue to conduct early clinical development and regulatory activities within the AG-221 development program in collaboration with Celgene. Celgene is responsible for all development costs for AG-221. Agios is eligible for up to $120 million in milestone payments and a tiered royalty on any net sales. Agios also has the right to conduct a portion of any commercialization activities for AG-221 in the United States. AG-221 is part of Agiosí IDH portfolio that also includes the IDH1 mutant inhibitor AG-120, which the company continues to develop and is in Phase 1 clinical trials in advanced solid tumors and hematologic malignancies. Agios retains U.S. rights to the IDH1 program, and Celgene has an exclusive option to ex-U.S. rights for the program. Agios continues to advance its discovery and research of cancer metabolism targets.
News For AGIO;CELG From The Last 14 Days
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December 9, 2014
08:28 EDTCELGCelgene price target raised to $130 from $112 at UBS
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07:44 EDTCELGAmerican Association for Cancer Research to hold a symposium
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05:46 EDTCELGCelgene presents POMALYST/IMNOVID Phase IIIb study results at ASH meeting
Celgene announced that results from the STRATUS trial, a single-arm phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma were presented at the 56th American Society of Hematology annual meeting. Pomalidomide is marketed as POMALYST in the United States and IMNOVID in the European Union. In the study, 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib had been enrolled at the time of the data cutoff. The primary endpoint was safety, and key secondary endpoints included pomalidomide exposure, overall response rate, or ORR, duration of response, or DOR, progression-free survival, or PFS, overall survival, or OS, and cytogenetic analyses. Patients had a median five prior therapies. All patients received thromboprophylaxis with low-dose aspirin, low-molecular-weight heparin, or equivalent. At a median follow-up of 6.8 months with a median four cycles received, the median PFS and OS were 4.2 months and 11.9 months, respectively. The ORR was 35%, with 8% of patients achieving at least a very good partial response, or VGPR. The median DOR was 6.8 months. In patients refractory to prior lenalidomide or lenalidomide and bortezomib, similar PFS, OS, and ORR were achieved.
05:22 EDTCELGCelgene reports REVLIMID study data suggests improved response rates, PFS, OS
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05:17 EDTCELGCelgene reports Vidaza Phase III study shows doubled overall survival times
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December 8, 2014
14:06 EDTCELGCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:54 EDTCELGCelgene announces results from phase lll Revlimid study
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13:02 EDTAGIOAgios Pharmaceuticals says Phase 1 AG-348 trials met primary endpoints
Agios Pharmaceuticals presented the first clinical data from its Phase 1 single and multiple ascending dose clinical trials of AG-348 in healthy volunteers. These results provide early proof-of-mechanism for AG-348, a novel, first-in-class, oral activator of both wild type and mutated pyruvate kinase-R enzymes. In these Phase 1 studies, dosing of AG-348 over 14-days in healthy volunteers resulted in a dose-dependent increase in the pyruvate kinase-R pathway as evidenced by a substantial increase in ATP and decrease in 2,3-DPG levels, which are key biomarkers of PKR activity and primary indicators of PK deficiency. These data support the hypothesis that AG-348 treatment may similarly enhance PKR activity in patients with PK deficiency and thus correct the underlying defect of the disease. These results will be presented during a poster session at the 56th Annual Meeting of the American Society of Hematology. The results being reported are from 64 healthy volunteers who received either AG-348 or placebo, which includes 48 people from the completed SAD study and 16 people in the first two cohorts of the ongoing MAD study that recently completed enrollment. Complete safety results are being reported from the SAD Phase 1 study and showed that AG-348 was well tolerated. Although the MAD study remains blinded, no serious adverse events have been reported in the first two analyzed cohorts. AG-348 also showed a favorable pharmacokinetic profile with rapid absorption, low variability and dose-proportional increase in exposure following both single and multiple doses. The observed dose-dependent changes in 2,3-DPG and ATP blood levels seen are consistent with a substantial increase in PKR enzymatic activity. The Phase 1 studies are randomized, double blind, placebo-controlled trials evaluating single ascending and multiple ascending oral doses for 14 days. The primary objectives of the studies are to assess safety and tolerability of AG-348 in healthy subjects and identify a safe and pharmacodynamically active dose and schedule for future studies in patients with PK deficiency. Secondary objectives are designed to characterize the pharmacokinetics of AG-348 and the PK/PD relationship between AG-348, ATP, and 2,3-DPG. Both trials successfully met their respective primary endpoints.
09:20 EDTAGIOOn The Fly: Pre-market Movers
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07:39 EDTAGIOAgios Pharmaceuticals volatility low into new data from Ongoing Phase 1 trial
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07:36 EDTAGIO, CELGAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.
07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
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05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
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December 7, 2014
16:40 EDTCELG, AGIOAgios announces new data from Ongoing Phase 1 trial of AG-221
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14:14 EDTAGIOAgios Pharmaceuticals to hold a luncheon discussion
Investor Luncheon to review data presented at the American Society of Hematology's Annual Meeting is being held in San Francisco on December 8 at 3 pm. Webcast Link
14:10 EDTCELG, AGIOAmerican Society of Hematology to hold a meeting
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13:16 EDTCELGCelgene, Acceleron announced data from luspatercept phase 2 clinical trial
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December 6, 2014
09:28 EDTCELGCelgene to hold an analyst and investor event
Analyst and Investor Event being held in conjunction with the American Society of Hematology's 56th Annual Meeting in San Francisco on December 7 at 11 pm. Webcast Link
December 4, 2014
10:08 EDTAGIOOn The Fly: Analyst Initiation Summary
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08:33 EDTAGIOAgios Pharmaceuticals initiated with a Buy at MLV & Co.
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