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News Breaks
June 13, 2014
08:04 EDTAGIO, CELGAgios 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 Agios’ 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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March 26, 2015
12:13 EDTCELGCelgene, MorphoSys mutually agree to end MOR202 collaboration
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09:36 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TWTR FB KRFT BIDU TSLA CELG NFLX FCAU
06:45 EDTCELGBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 24, 2015
15:06 EDTAGIOAgios Pharmaceuticals announces orphan drug designation of AG-348
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14:03 EDTAGIOAgios pyruvate kinase deficiency treatment granted FDA orphan status
The FDA designated an allosteric activator of the red blood cell-specific form of pyruvate kinase from Agios Pharmaceuticals as an orphan treatment of pyruvate kinase deficiency, the FDA stated in a post to its site. Reference Link
07:26 EDTCELGCelgene drug competitor will need additional studies, says UBS
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March 23, 2015
16:01 EDTCELGOptions Update; March 23, 2015
iPath S&P 500 VIX Short-Term Futures down 48c to 25.24 Option volume leaders: AAPL TSLA TWTR GILD CELG FB TSLA AMZN TEVA PBR according to Track Data.
11:32 EDTCELGStocks with call strike movement; GILD CELG
Gilead (GILD) August 115 call option implied volatility increased 5% to 27, Celgene (CELG) July 140 call option implied volatility increased 3% to 28 according to IVolatility.
09:37 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AUY SLB PFE MCP CELG VRTX SHPG GILD LOGI TSLA TASR NFLX SCTY WFM
05:55 EDTCELGStocks with implied volatility movement; AMZN CELG
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March 20, 2015
13:04 EDTCELGCelgene reports results from long-term efficacy,safety analyses of Otezla trials
Celgene announced that results from long-term efficacy and safety analyses of the ESTEEM phase III clinical trial program of Otezla were presented at the 73rd Annual Meeting of the American Academy of Dermatology. OTEZLA is the company’s oral, selective inhibitor of phosphodiesterase 4 approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis. In ESTEEM 1 and 2, patients were randomized to treatment with OTEZLA 30 mg twice daily or placebo for the first 16 weeks. At week 16, patients either continued on OTEZLA or were switched from placebo to OTEZLA 30 mg twice daily through week 32. Patients initially randomized to OTEZLA who achieved a Psoriasis Area and Severity Index-75 response or PASI-50 response at week 32 were then re-randomized to either OTEZLA 30 mg twice daily or placebo. Celgene said improvements in the severity of preexisting nail, scalp and palmoplantar psoriasis achieved at week 16 were maintained in OTEZLA responders through week 52 in ESTEEM 2; OTEZLA improved the severity of palmoplantar psoriasis at week 16 in a subset of patients across three trials; Long-term safety profile for up to 104 weeks in ESTEEM 1 was consistent with previously reported data from OTEZLA clinical trial programs, with no new safety signals and no clinically meaningful changes in laboratory values.
13:01 EDTCELGCelgene announces positive Phase III study results evaluating Otezla
Celgene announced that results from its ongoing phase III LIBERATE trial evaluating Otezla, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with moderate to severe plaque psoriasis. The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16. At week 16, patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index-75 response. At week 16, statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg when compared with placebo. A post-hoc analysis revealed no significant difference between OTEZLA and etanercept in PASI-75 at week 16. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
10:51 EDTCELGStocks with call strike movement; DAL CELG
Delta Air Lines (DAL) September 57.5 call option implied volatility decreased 1% to 34, Celgene (CELG) July 145 call option implied volatility increased 3% to 28 according to IVolatility.
09:45 EDTCELGActive equity options trading on open
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07:41 EDTCELGAmerican Academy of Dermatology to hold annual meeting
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06:26 EDTCELGCelgene price target raised to $144 from $135 at Piper Jaffray
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March 19, 2015
09:37 EDTCELGActive equity options trading on open
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March 18, 2015
17:07 EDTCELGCelgene GED-0301 Phase II data published in New England Journal of Medicine
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