Agreements, NDA Submissions, FDA Approvals, Enrollment Updates, and Index Inclusions - Analyst Notes on Jazz Pharmaceuticals, Vertex, NPS, StemCells and Achillion
Editor Note: For more information about this release, please scroll to bottom.
NEW YORK, July 7, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX), NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), StemCells, Inc. (NASDAQ: STEM) and Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/4482-100free.
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Jazz Pharmaceuticals plc Analyst Notes
On July 2, 2014, Jazz Pharmaceuticals plc (Jazz Pharmaceuticals) announced that it has signed a definitive agreement with Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau). Under the agreement, a subsidiary of Jazz Pharmaceuticals will acquire from Sigma-Tau, rights to defibrotide in the US as well as all other countries in the Americas. Further, as part of the agreement, Sigma-Tau will receive an upfront payment of $75.0 million upon closing of the transaction. The Company stated that Sigma-Tau would also be eligible to receive milestone payments of $25 million upon the acceptance for filing by the FDA of the first NDA for defibrotide for VOD. Jazz Pharmaceuticals stated that it intends to fund the transaction with cash on hand and expects the transaction to close in Q3 2014. The full analyst notes on Jazz Pharmaceuticals are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/JAZZ/report.pdf
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Vertex Pharmaceuticals Incorporated Analyst Notes
On June 30, 2014, Vertex Pharmaceuticals Incorporated (Vertex) announced the submission of a supplemental New Drug Application (sNDA) to the FDA for the approval of KALYDECO in people with cystic fibrosis (CF) with ages 18 and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Jeffrey Chodakewitz, M.D., Senior Vice President and Chief Medical Officer at Vertex said, "This submission is another step forward in our goal to help more people with this devastating disease. While people with the R117H mutation exhibit a wide range in the severity of their disease, their lung function often declines as they get older, marking the need for new medicines." The Company stated that it also plans to submit a Marketing Authorization Application (MAA) variation in Europe in Q3 2014 for people with CF ages 18 and older who have the R117H mutation in the CFTR gene. The full analyst notes on Vertex are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/VRTX/report.pdf
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NPS Pharmaceuticals, Inc. Analyst Notes
On June 30, 2014, NPS Pharmaceuticals, Inc. (NPS) announced that the FDA has approved updated labelling for Gattex for injection to include long-term data from the STEPS 2 study of adult patients with Short Bowel Syndrome (SBS). The Company reported that the data shows that patients who continued Gattex treatment beyond two years achieved clinically significant reductions in parenteral support requirements with 13 out of 88 patients across all groups achieving complete independence. We are pleased that the FDA has approved updated labeling for Gattex, as it provides important information for healthcare professionals and patients about long-term use of Gattex therapy," said Roger Garceau, MD, FAAP, Executive Vice President and Chief Medical Officer of NPS Pharma. The full analyst notes on NPS are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/NPSP/report.pdf
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StemCells, Inc. Analyst Notes
On June 20, 2014, StemCells, Inc. (StemCells) announced that based on positive interim results, the Company has closed enrollment in its Phase I/II clinical trial for dry age-related macular degeneration (AMD). The Company stated that it has closed enrollment for said trial to focus on its efforts on a follow-on Phase II randomized, controlled proof-of-concept study, later in 2014. StemCells informed that the final results for the current AMD trial are expected to be released mid-2015. Stephen Huhn, M.D., FACS, FAAP, Vice President, CNS Clinical Research and Chief Medical Officer, StemCells said, "These positive clinical safety and efficacy findings are an important milestone in our goal of developing a first-in-class therapy for dry AMD based on our proprietary HuCNS-SC platform technology." The full analyst notes on StemCells are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/STEM/report.pdf
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Achillion Pharmaceuticals, Inc. Analyst Notes
On July 1, 2014, Achillion Pharmaceuticals, Inc. (Achillion) announced that it was added to the Russell 2000 and Russell Microcap Indexes. The Company informed that in June every year Russell realigns its family of global equity indexes to reflect market changes in the past year. Achillion added that yearly reconstitution of Russell's US indexes captures the 4,000 largest US stocks as of the end of May, and they are ranked by total market capitalization. The full analyst notes on Achillion are available to download free of charge at:
http://www.analystsreview.com/Jul-07-2014/ACHN/report.pdf
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