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News Breaks
April 22, 2014
07:05 EDTSLXP, PGNXSalix, Progenics announce RELISTOR EMA submission accepted
Salix (SLXP) and Progenics (PGNX) announced that the submission to the European Medicines Agency of RELISTOR has been accepted for review. If approved, this will add to the current marketing authorization in the European Union, which allows for the use of RELISTOR in advanced illness patients. The marketing of RELISTOR for the treatment of OIC in advanced illness patients was approved in the European Union in 2008, and is currently approved in more than 50 countries. If approved, it is anticipated that RELISTOR will be immediately available to this newly expanded population of patients in the EU using opioids to control chronic pain.
News For SLXP;PGNX From The Last 14 Days
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October 21, 2014
07:07 EDTSLXPSalix to present results of TARGET 3 study with Rifaximin 550mg for IBS
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October 20, 2014
08:19 EDTPGNXProgenics presents data from Phase 2 trial of 1404 PSMA imaging agent
Progenics Pharmaceuticals announced that data from a Phase 2 trial of its PSMA imaging agent candidate, 1404, have been presented at the 27th Annual European Association of Nuclear Medicine Congress being held in Gothenburg, Sweden. 1404 is a targeted small molecule designed to "visualize" prostate cancer by targeting prostate specific membrane antigen. "The Phase 2 data are quite impressive and demonstrate how SPECT/CT with 1404 may provide a more accurate assessment of the presence, location and extent of prostate cancer," said Dr. Dabasi. Gabriella Dabasi, Ph.D. presented, "1404 may provide prognostic information for both primary and metastatic disease in a single procedure, which could greatly enhance the clinical decision-making process. There is a strong rationale for continued development of this promising molecular imaging agent." In the Phase 2 trial, SPECT/CT imaging with 1404 showed 94% sensitivity in detecting and imaging cancer in the prostate gland of high-risk patients prior to prostatectomy. In addition, 1404 was more sensitive than MRI in detecting primary prostate cancer and was a good predictor of lymph node involvement at prostatectomy. SPECT/CT imaging with 1404 identified 14 more patients with suspicious lymph node sites than MRI. Uptake of 1404 in the lobes of the prostate gland showed a highly significant correlation with Gleason score. The data also showed uptake of 1404 in the primary tumor was significantly lower in treated patient, corresponding to a decrease in PSA over time observed in these treated patients.
October 16, 2014
15:10 EDTSLXPAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
October 9, 2014
11:14 EDTSLXPAllergan raises outlook again as Valeant pursuit continues
Drug maker Allergan (AGN) this morning preannounced stronger than expected results and again raised its fiscal year profit guidance. The beat and raise results come after The Wall Street Journal reported on Tuesday that drug maker Valeant (VRX) and hedge fund Pershing Square intend to raise their previous bid for Allergan by $15 per share to about $191. Meanwhile, also on Tuesday, Reuters said that drug maker Actavis (ACT) plans to make a new merger offer to Allergan, and sources indicated to the news service that Allergan may be willing to consider an offer from Actavis if the bid is for more than $200 per share. WHAT'S NEW: Allergan estimated that its third quarter earnings per share would come in at $1.76-$1.78, versus analysts' consensus estimate of $1.48. The drug maker had previously provided Q3 EPS guidance of $1.44-$1.47. Allergan raised its fiscal 2014 EPS guidance to $6.20-$6.25 from $5.74-$5.80. Analysts' consensus estimate was $5.81. This is the fourth time that Allergan has raised its guidance this year. Allergan said that its markets have been strong around the world, while it is gaining market share in most categories. ANALYST REACTION: In a note to investors today, Wells Fargo analyst Larry Biegelsen wrote that, in the wake of Allergan's guidance increase, the company's price to earnings multiple could expand to 22x its estimated 2016 earnings, up from its current multiple of 19x. In addition to the raised guidance, a potential accretive acquisition by Allergan and the possibility that it will be acquired make such an increase in the multiple "quite possible," Biegelsen contended. He kept an Outperform rating on the stock. WHAT'S NOTABLE: Allergan has reportedly held advanced talks about acquiring another company in the sector, Salix (SLXP), although CNBC's David Faber on October 2 reported that the talks between the two companies about a merger had "cooled considerably." PRICE ACTION: In late morning trading, Allergan rose fractionally to $191.06 while Valeant slid 1.5% to $124.08.
08:50 EDTSLXPAllergan shares have further upside, says Wells Fargo
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October 8, 2014
08:42 EDTSLXPSalix shares should be bought on weakness, says Sterne Agee
After Reuters yesterday afternoon reported that Actavis (ACT) plans to make a new merger approach to Allergan (AGN), Sterne Agee believes that Salix's standalone value is $162. The firm expects the shares to reach that level following approval of its Xifaxan IBS-D drug after the February 2015 PDUFA date.
08:31 EDTSLXPSalix announces FDA granted final approval for UCERIS
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06:23 EDTSLXPActavis more inclined to pursue Allergan over Salix, says Citigroup
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