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Stock Market & Financial Investment News

News Breaks
March 25, 2014
06:57 EDTQCOR, KERX, AUXL, CBST, IRWD, ACRX, SLXP, BCRXBiotech weakness a buying opportunity, says Mizuho
Mizuho said the recent weakness in biotech will prove transient and has created buying opportunities in AcelRx (ACRX), Auxilium (AUXL), BioCryst (BCRX), Ironwood (IRWD), Keryx (KERX), Salix (SLXP), Cubist (CBST), and Questcor (QCOR).
News For ACRX;AUXL;BCRX;IRWD;KERX;SLXP;CBST;QCOR From The Last 14 Days
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July 29, 2015
10:41 EDTKERXOptions with increasing implied volatility
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10:27 EDTKERXOptions with decreasing implied volatility
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July 27, 2015
08:26 EDTKERXKeryx appoints Scott Holmes as CFO
Keryx Biopharmaceuticals announced the appointment of Scott A. Holmes to CFO effective immediately. Holmes will be responsible for Keryx's finance function and will be a member of the company's executive team. He will succeed James Oliviero whose planned departure was announced earlier this year. Oliviero will stay with the company through a transition period. Holmes brings nearly 20 years of life sciences and financial management expertise to Keryx. He joins the company from AMAG Pharmaceuticals where he most recently served as senior vice president, finance and investor relations during a period of high growth driven by acquisitions and public financings. Prior to AMAG, from 2009 to 2011, he was vice president of finance and treasurer of Molecular Biometrics.
July 24, 2015
08:34 EDTACRXAcelRx's Zalviso recommended for marketing authorization by Europe's CHMP
AcelRx Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, has adopted a positive opinion for Zalviso. The opinion, while not binding, recommends marketing authorization for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. Zalviso is an investigational drug-device combination product designed to deliver a sublingual formulation of sufentanil 15 mcg via a proprietary pre-programmed, non-invasive, patient-controlled device. The positive opinion by the CHMP will next be reviewed by the European Commission for central marketing authorization in the European Union. If approved, Grunenthal expects to launch Zalviso beginning in 1H16. In addition, AcelRx would be eligible to receive a $15M milestone payment from AcelRx's licensee in Europe, Grunenthal, upon approval. AcelRx had previously received CE Mark approval of the Zalviso device and ISO certification of its quality management system issued by the British Standards Institution.
07:13 EDTKERXKeryx receives CHMP positive opinion for Fexeric
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July 23, 2015
10:00 EDTKERXOn The Fly: Analyst Downgrade Summary
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08:06 EDTKERXKeryx downgraded to Market Perform from Outperform at Cowen
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July 22, 2015
07:38 EDTIRWDIronwood announces data from Phase I IW-1973 study
Ironwood Pharmaceuticals announced top-line data from a Phase I study of IW-1973, its lead investigational soluble guanylate cyclase stimulator. In the study, IW-1973 demonstrated cardiovascular pharmacodynamic effects, extensive tissue distribution, proof of mechanism for sGC stimulation, and a dose range that was well tolerated in healthy volunteers. The totality of clinical and preclinical data generated to date strongly support continued development of IW-1973 as a potential once-daily oral therapy. Ironwood intends to initiate a Phase Ib multiple ascending dose study of IW-1973 in the fourth quarter of 2015. This study will inform the selection of doses and priority indications for the Phase II program, which will focus on areas with the highest unmet need and optimal path to market. Ironwood intends to initiate at least two Phase II proof of concept studies for IW-1973 in 2016. The randomized, double-blind, placebo-controlled, single ascending dose Phase I study enrolled 46 healthy volunteers. Participants were randomized 3:1 to receive a single dose of IW-1973 or placebo administered via an oral capsule. Top-line clinical data were consistent with preclinical findings and included cardiovascular pharmacodynamic effects, dose-proportional pharmacokinetics, biomarker-based confirmation of target engagement, and evidence of extensive distribution to tissues. No serious adverse events were reported. Reported adverse events were consistent with the mechanism of action. Data from clinical and preclinical studies of IW-1973 are expected to be presented at a future medical conference.

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