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News Breaks
August 6, 2014
17:35 EDTVTLVital Therapies reports Q2 EPS (91c), may not compare to consensus (55c)
Based on its current business plan, the company believes its existing cash and cash equivalents as of June 30, along with the net proceeds from its IPO will be sufficient to fund its operations into the second quarter of 2016.
News For VTL From The Last 14 Days
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September 29, 2015
10:00 EDTVTLOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: ARM Holdings (ARMH) downgraded to Neutral from Buy at Natixis... Arthur J. Gallagher (AJG) downgraded to Hold from Buy at Sandler ONeill... CareDx (CDNA) downgraded to Market Perform from Outperform at Raymond James... Carlisle (CSL) downgraded to Sector Weight from Overweight at KeyBanc... Imation (IMN) downgraded to Hold from Buy at Lake Street... Mediaset Espana (GETVF) downgraded to Underweight from Equal Weight at Barclays... New Source Energy (NSLP) downgraded to Sell from Hold at Wunderlich... Peugeot (PUGOY) downgraded to Buy from Conviction Buy at Goldman... RTL Group (RGXLY) downgraded to Equal Weight from Overweight at Barclays... Regal-Beloit (RBC) downgraded to Neutral from Buy at Buckingham... Sequenom (SQNM) downgraded to Market Perform from Outperform at William Blair... Southern Copper (SCCO) downgraded to Sector Perform at Scotia Howard Weil... TerraForm Global (GLBL) downgraded to Neutral from Overweight at JPMorgan... Verastem (VSTM) downgraded to Hold from Buy at Jefferies... Vital Therapies (VTL) downgraded to Neutral from Buy at SunTrust... Williams (WMB) downgraded to Sector Perform from Outperform at Scotia Howard Weil.
08:14 EDTVTLVital Therapies downgraded to Neutral from Buy at SunTrust
SunTrust downgraded Vital Therapies after the company reported top-line data from the pivotal VTI-208 trial that failed to meet its primary and secondary endpoints. Target to $5 from $50.
September 28, 2015
07:16 EDTVTLVital Therapies outlines Phase 3 ELAD trial plans
Vital Therapies outlined plans for a possible new phase 3 clinical trial designed to confirm ELAD's safety and efficacy in alcohol-induced liver decompensation, including severe acute alcoholic hepatitis, based on trends identified in subset analyses of the company's recently completed VTI-208 clinical trial. On August 21, 2015, the Company announced that while its first phase 3 trial, VTI-208, did not reach its primary or secondary endpoints, medically pertinent pre-specified subsets based on age and disease severity did show promising trends toward efficacy. Since then, the Company has conducted a series of pre-specified and post-hoc analyses of subsets of the data in order to determine if there is a basis for designing and implementing a new clinical trial to confirm the efficacy and safety signals identified in these subsets. The Company has drafted a preliminary protocol for the proposed new clinical trial, to be known as VTL-308, incorporating limits on age and factors associated with kidney dysfunction and blood clotting dysfunction, which are discrete components of the Model for End Stage Liver Disease score. Key features of the preliminary VTL-308 protocol are being reviewed with the Company's Clinical Advisory Board and many proposed clinical investigators. While additional modifications are possible, this preliminary protocol will be used in planning for the new trial. A dialogue with the U.S. Food and Drug Administration has been initiated and the Company has been granted a Type C meeting to review the VTL-308 protocol and discuss whether the results, if positive, would be accepted as the basis for a biologics license application, or BLA, filing, potentially supported by the VTI-208 subset analyses. The Company plans to submit the VTL-308 protocol to the FDA early in the fourth quarter, followed shortly thereafter with submissions to various European regulatory authorities. The Company also expects to begin the process of opening clinical sites in the fourth quarter. The clinical sites selected to participate in VTL-308 will be comprised mostly of high enrolling sites from VTI-208, with approximately 35 sites targeted in U.S., U.K., Ireland, Germany and Spain. The Company anticipates enrolling the first subject in VTL-308 during the first half of 2016.

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