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May 14, 2014
04:55 EDTXLRN, XLRN, XLRN, AGIO, AGIO, AGIO, ALKS, ALKS, ALKS, ALNY, ALNY, ALNY, ARIA, ARIA, ARIA, EPZM, EPZM, EPZM, IMGN, IMGN, IMGN, TSRO, TSRO, TSROLeerink to hold a bus tour
Boston Biopharma Bus Tour travels throughout Boston on May 14-16.
News For XLRN;AGIO;ALKS;ALNY;ARIA;EPZM;IMGN;TSRO From The Last 14 Days
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December 8, 2014
14:06 EDTXLRNCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:32 EDTEPZMEpizyme announces results for PRMT5 inhibitor
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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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08:50 EDTALKSAlkermes price target raised to $63 on pipeline catalysts at Credit Suisse
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07:39 EDTAGIOAgios Pharmaceuticals volatility low into new data from Ongoing Phase 1 trial
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07:36 EDTAGIOAgios 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.
07:36 EDTARIAARIAD: Iclusig demonstrates anti-leukemic activity in patents in Phase 2 trial
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December 7, 2014
16:40 EDTAGIOAgios announces new data from Ongoing Phase 1 trial of AG-221
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14:23 EDTEPZMEpizyme to hold a luncheon discussion
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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 EDTXLRN, AGIOAmerican Society of Hematology to hold a meeting
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13:16 EDTXLRNCelgene, Acceleron announced data from luspatercept phase 2 clinical trial
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13:13 EDTALNYAlnylam files clinical trial application for ALN-CC5
Alnylam Pharmaceuticals announced that it has filed a Clinical Trial Application, CTA, with the U.K. Medicines and Healthcare products Regulatory Agency, MHRA, to initiate a Phase 1/2 clinical trial with ALN-CC5, a subcutaneously administered investigational RNAi therapeutic targeting complement component C5 for the treatment of complement-mediated diseases. As per the CTA filing, the intended clinical study of ALN-CC5 will be performed in normal human volunteers and, then, in patients with paroxysmal nocturnal hemoglobinuria, PNH. Following approval of the CTA, the company expects to initiate the Phase 1/2 study in early 2015, with initial data expected to be reported in mid-2015. In addition, Alnylam scientists presented new pre-clinical data at the 56th Annual Meeting of the American Society of Hematology. Amongst other reported research findings, new data showed an up to 99.2% knockdown of serum C5 and up to 96.2% inhibition of serum hemolytic activity in non-human primates, NHPs, with continued dosing for over seven months.
12:53 EDTIMGNImmunoGen announces 'encouraging' IMGN529 clinical data
ImmunoGen announced the presentation of encouraging clinical findings with its IMGN529 experimental therapy for B-cell malignancies at the American Society of Hematology annual meeting. These include objective responses at doses that were generally well tolerated. ImmunoGenís IMGN529 is a potential new treatment for DLBCL and other non-Hodgkin lymphoma, NHL, subtypes. An ADC, it comprises an antibody that targets CD37, found on B-cell malignancies, with the potent cancer cell-killing agent, DM1, attached. The antibody serves to deliver the DM1 specifically to B cells to kill them and, based on preclinical research, also contributes anticancer activity. IMGN529 is currently in the dose-finding portion of a Phase I clinical trial, which assesses increasing doses of this experimental therapy in new groups of patients with relapsed/refractory NHL. Findings with the first doses evaluated were reported previously.
December 5, 2014
10:35 EDTALKSHigh option volume stocks
High option volume stocks: NOAH FRAN BIG GREK KEY VIAB STRZ ALKS QTWW ONNN
08:39 EDTALNYAlnylam to host research and development day
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December 4, 2014
12:58 EDTEPZMPRIMECAP Management reports 8.47% passive stake in Epizyme
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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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