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July 14, 2014
07:07 EDTPGNX, SLXPFDA says RELISTOR can be approved on data submitted in sNDA
Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the Food and Drug Administration has informed Salix that RELISTOR can be approved on the data submitted in the sNDA. The FDA Office of Drug Evaluation III responded to the company’s formal appeal filed in response to the Complete Response Letter of July 27, 2012 to the supplemental NDA ) for RELISTOR. The Agency’s letter stated that, “Salix’s request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted.” This request for a proposal for a post-marketing observational study is in accordance with recommendations of the June 11-12, 2014 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee. Salix will work with the DGIEP in an effort to provide information to the division that will enable the division to approve RELISTOR for use by patients with chronic non-cancer pain and experiencing OIC.
News For SLXP;PGNX From The Last 14 Days
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January 30, 2015
06:52 EDTSLXPSalix price target raised to $160 from $130 at Piper Jaffray
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January 29, 2015
07:37 EDTSLXPSalix price target raised to $149 from $138 at Jefferies
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06:53 EDTSLXPSalix audit findings positive, says Cantor
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January 28, 2015
18:21 EDTSLXPOn The Fly: After Hours Movers
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16:47 EDTSLXPSalix provides update on audit committee review
Salix Pharmaceuticals announced that the Audit Committee of Salix’s Board of Directors, in consultation with its outside advisors and management, has determined that the Company’s previously issued consolidated financial statements for the full year 2013 and the first three quarters of 2014 require correction of certain errors and should no longer be relied upon. These restatements were based upon the results of an accounting review, conducted by outside counsel reporting to the Audit Committee and BDO Consulting, of potential accounting and financial reporting issues associated with sales to wholesalers and other wholesaler-related transactions. The errors, which are primarily related to the timing for recognition of certain revenue, revenue-reducing returns and discounts, and expense items, will be corrected in the Company’s restated financial statements. Salix believes the cumulative impact for correcting these matters over all previously reported periods affected by the restatement will decrease previously reported net product revenue and net income by approximately $20.7M and $11.9M, respectively. For the full year 2013, this would decrease previously reported net product revenue and net income by approximately $20.1M and $11.8M, respectively. For the nine months ended September 30, 2014, this would decrease previously reported net product revenue by $0.7M and result in no change in net loss. “The conclusion of the accounting portion of the ongoing Audit Committee review is an important milestone,” said Thomas W. D'Alonzo, Chairman of the Board of Salix. “While in total the restatements are minor in scale, the Audit Committee takes these matters very seriously and is in the process of promptly enhancing controls and procedures to ensure this never happens again.”
January 23, 2015
08:09 EDTPGNXProgenics relaunches Azedra Phase 2 clinical study
Progenics Pharmaceuticals announced that it has dosed the first subject in the resumed pivotal Phase 2 clinical study of Azedra in patients with malignant pheochromocytoma and paraganglioma. The trial is being conducted under a Special Protocol Assessment, or SPA, with the FDA. Progenics acquired Azedra in conjunction with its 2013 acquisition of Molecular Insight Pharmaceuticals, or MIP. The study is designed to evaluate the efficacy and safety of the administration of two therapeutic doses of Azedra in patients with malignant relapsed/refractory pheochromocytoma or paraganglioma, ultra-orphan cancers with limited treatment options. The primary objective of the study is to determine the clinical benefit of Azedra based on the proportion of study participants with a reduction of all antihypertensive medication by at least 50% for at least six months. The SPA requires that 25% of 58 evaluable patients achieve the primary endpoint. In late 2010, MIP suspended enrollment in the trial to seek additional funding. The trial has now resumed to fulfill enrollment requirements under the SPA.
January 21, 2015
12:30 EDTSLXPGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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January 20, 2015
14:31 EDTSLXPSalix climbs after Reuters says strategic options being explored
Shares of Salix Pharmaceuticals (SLXP) are jumping after Reuters reported that the company is working with investment bank Centerview Partners to explore strategic options, including a possible sale to a larger peer. On January 6, Cantor and Piper Jaffray wrote that the retirement of the company's CEO increased the chances that it would look to sell itself. Salix develops treatments for bowel disorders. WHAT'S NEW: Salix has hired Centerview Partners to help it explore various options, including a possible sale to a larger drug maker, Reuters reported this afternoon, citing three unnamed sources. However, Salix has not determined if it will look to sell itself now or wait until it hires a new CEO, the news service added. ANALYST VIEW: On January 6, after Salix announced that its CEO would retire, Cantor analyst Irina Koffler wrote that the retirement could "pave the way" for a sale of the company. The analyst wrote that "all options could be on the table." She raised her price target on the stock to $145 from $127 and kept a Buy rating on Salix shares. Similarly, Piper Jaffray analyst David Amsellem wrote that the CEO's departure, combined with the company's announcement last month of an accelerated workdown of its inventory levels, sets the stage for an eventual sale of the company. There would be "ample interest" in acquiring the company, added the analyst, who kept a $130 price target and Overweight rating on the shares. PRICE ACTION: In mid-afternoon trading, Salix jumped about 5% to trade near $126 per share.
14:23 EDTSLXPSalix calls active on exploring options report
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14:13 EDTSLXPSalix exploring options, including potential sale, Reuters reports
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13:48 EDTSLXPSalix exploring options with help of Centerview, Reuters reports
10:06 EDTPGNXHigh option volume stocks
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