Wed, Sep. 21, 4:37 PM
- Ocera Therapeutics (NASDAQ:OCRX) completes enrollment in its Phase 2a clinical trial, STOP-ALF, assessing lead product candidate OCR-002 (ornithine phenylacetate), an ammonia scavenger, for the treatment of acute liver failure (ALF). The study is being conducted by an NIH-sponsored network of liver transplant sites called the Acute Liver Failure Study Group. Ocera is supporting and supplying product.
- There have been no serious treatment-related safety issues at any dose level. Top-line results have been submitted for presentation at The Liver Meeting in Boston, November 11 - 15.
- STOP-ALF is an open-label, two-arm study. Participants are being treated following one of four escalating dosing regimens of intravenously administered OCR-002 and have been advanced only after safety and pharmacokinetic data were reviewed. Cohort 1 consists of ALF patients with minimal renal dysfunction. Cohort 2 includes ALF patients with compromised renal function. Dose levels within the four regimens have ranged from 3.33 g/24 hours to 20 g/24 hours for up to five treatment days. 77% of subjects (n=36/47) have been considered evaluable after completing at least 72 hours of treatment. The primary endpoint is safety and tolerability as defined by the number of patients with adverse events. According to ClinicalTrials.gov, the estimated study completion date is September 2017.
- Shares are up 20% after hours on light volume.
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- Ocera Therapeutics (NASDAQ:OCRX): Q4 EPS of -$0.34 misses by $0.01.
- Revenue of $0.02M (-33.3% Y/Y) beats by $0.01M.
Fri, Feb. 26, 1:53 PM
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- Shire plc (SHPG -0.6%) initiated with Buy rating by Cantor Fitzgerald.
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- IMS Health Holdings (IMS +0.2%) initiated with Outperform rating and $31 (19% upside) price target by Leerink Swann.
- Ocera Therapeutics (OCRX +5.7%) initiated with Buy rating and $10 (229% upside) price target by Brean Capital.
- Repligen (RGEN +3.8%) initiated with Buy rating and $36 (35% upside) price target by Craig-Hallum.
- Mesoblast (MESO -2.2%) initiated with Neutral rating and $5.50 (12% downside risk) price target by Chardan Capital.
- Ultragenyx Pharmaceutical (RARE +1.2%) initiated with Buy rating and $80 (29% upside) price target by Leerink Swann.
- Teva Pharmaceutical Industries (TEVA -0.2%) initiated with Outperform rating with $68-71 (21% upside from midpoint) price target by Wells Fargo.
- Medivation (MDVN +9.8%) initiated with Buy rating and $46 (28% upside) price target by Bank of America.
- Collegium Pharmaceutical (COLL -0.1%) initiated with Outperform rating and $35 (83% upside) price target by William Blair.
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