Shares of biotechnology company Prosensa Holding NV (NASDAQ:RNA) jumped Monday to a new 52-week high after rival Sarepta Therapeutics (SRPT), which is competing in the space of treatments for Duchenne muscular dystrophy, was dealt a setback for a new-drug application. Prosensa earlier this month started the submission process for a new-drug application regulatory filing to the U.S. Food & Drug Administration for Drisapersen, which is intended to treat Duchenne muscular dystrophy and has received a fast-track status from the FDA. Prosensa Holding NV (NASDAQ:RNA) expects the submission to be completed by the end of the year.Sarepta, meanwhile, said Monday that the FDA needs additional data as part of the new-drug application for its Eteplirsen treatment of Duchenne Muscular Dystrophy and that it plans to submit an NDA by mid-year 2015. SRPT was down 36% to $15.19 in recent trading shortly after Monday's open as its investors registered their disappointment with the setback. It has a 52-week range of $12.12 to $44.03. RNA, meanwhile, was up 14% at $13.65 recently, and hit an intraday high of $13.75, its highest level since September 2013.CorMedix Inc. (NYSEMKT:CRMD) said the United States Food and Drug Administration has reviewed its Investigational New Drug application for Neutrolin, which was submitted September 24, 2014, and determined that the IND is not subject to a clinical hold, and that a pivotal clinical study can be initiated in the United States. CorMedix Inc. (NYSEMKT:CRMD) is a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. The IND includes a pivotal Phase 3 protocol for Neutrolin in hemodialysis patients with a central venous catheter. The Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. CRMD trades in a 52-week range of $0.66 to $3.20.NQ Mobile Inc (ADR) (NYSE:NQ), the provider of mobile Internet services said it filed its annual report for 2013 on Form 20-F with the U.S. Securities and Exchange Commission, regaining full compliance. The annual report on Form 20-F contains the unqualified audited financial statements for the three years ended Dec. 31, 2013, which "contain no qualification and no adverse findings and are consistent with the company's previous financial disclosures and reports." It follows an extensive review of the business and financial affairs of the company, in which an audit committee "was able to conclude that there was no evidence of an effort within the company to delete any documents relevant to the Special Committee's investigation." NQ Mobile Inc (ADR) (NYSE:NQ) trades in a 52-week range of $3.45 to $22.33. The report shows the company's cash and cash equivalents as of Dec. 31, 2013, were about $283 million, "and major expenditures were confirmed as having been incurred for legitimate business purposes," the company added.
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