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Stock Market & Financial Investment News

News Breaks
February 10, 2014
04:55 EDTALKS, ALKS, RGDO, RGDO, LXRX, LXRX, ZIOP, ZIOP, RNA, RNA, AUXL, AUXL, XON, XON, SIGA, SIGA, GALE, GALE, MSTX, MSTXBiotech Industry Organization to hold a conference
16h Annual BIO CEO & Investor Conference is being held in New York on February 10-11.
News For ALKS;GALE;SIGA;XON;AUXL;RNA;ZIOP;LXRX;RGDO;MSTX From The Last 14 Days
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August 24, 2015
08:11 EDTALKSAlkermes delay for Aristada due to administrative issues, says Jefferies
Jefferies said it appears that the FDA's delay in approving Alkermes' Aristada is due to the agency's need for some additional review time. The firm said the fact that the FDA did not choose to issue a CRL letter gives it confidence that Alkermes should receive full approval in a "few weeks" and it maintains its Buy rating and $76 price target on the stock.
07:07 EDTGALEIDMC recommends reduction of cardiac toxicity monitoring in Galena NeuVax trial
Galena Biopharma announced that the Independent Data Monitoring Committee, or IDMC, has recommended to the company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax Phase 3 Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, or PRESENT, clinical trial. The trial is being run under a Special Protocol Assessment, or SPA, approved by the FDA. Following its most recent IDMC meeting in June, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram, or ECHO, or multiple-gated acquisition, or MUGA, scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.
August 21, 2015
16:01 EDTALKSAlkermes provides update on FDA review of ARISTADA
Alkermes announced that the U.S. FDA has advised Alkermes that it will not be able to complete its review of the New Drug Application for ARISTADA for the treatment of schizophrenia by the Prescription Drug User Fee Act action date of Aug. 22, 2015. The FDA indicated that this delay was expected to be brief, measured in terms of weeks, but could not confirm specific timing. The FDA also indicated that no additional data or information is required from Alkermes at this time. "We are confident in the ARISTADA program and our NDA submission, and we will work closely with the FDA as they complete their review," said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "We look forward to bringing ARISTADA to market as a potential new treatment option to help address the significant unmet medical needs of patients living with schizophrenia."
11:01 EDTXONCitron says 'been waiting' for opportunity to buy Intrexon
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09:11 EDTXONIntrexon 4.7M share Spot Secondary priced at $41.00
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08:05 EDTZIOPZiopharm discloses that it entered into a R&D agreement with MD Anderson
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August 20, 2015
19:02 EDTXONOn The Fly: After Hours Movers
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16:12 EDTXONIntrexon to offer common stock, no amount given
JMP Securities is acting as sole book-running manager and Stifel is acting as lead manager for the offering.
08:03 EDTXONIntrexon and Dominion enter exclusive agreement in Marcellus and Utica basins
Intrexon (XON) announced that Intrexon Energy Partners, and Dominion Energy, a subsidiary of Dominion (D), have entered into an agreement to explore the potential for commercial-scale biological conversion of natural gas to isobutanol, a drop-in fuel with numerous advantages over other clean burning gasoline blendstocks. Under the terms of the agreement, IEP will be required to meet specific development milestones prior to initiation of certain commercialization activities, which are subject to board approval by both parties. Dominion will be the exclusive partner to construct, own, operate, and maintain the production facilities in the Marcellus and Utica Shale Basins located in eastern North America via potential long-term services agreements with IEP. Within this geographic region, the collaboration plans to build natural gas bioconversion facilities leading to the creation of job opportunities and generation of local and state tax revenue.

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