Healthcare Review: Response Genetics, Vivus, Accuray, AcelRx, Insulet Print E-mail
By Staff and Wire Reports   
Friday, 20 September 2013 13:01

Wall Street was little changed on Friday, as investors waited to see if speeches by several U.S. Federal Reserve officials would shed light on the Fed's surprise decision to maintain stimulus for now and how much longer the program was likely to continue. The Nasdaq was supported by shares of Apple Inc, which rose 0.6 percent to $475.40 as the company released the latest version of its iPhone product line.

Shares of Response Genetics ($RGDX) are enjoying a strong session. In a regulatory filing (8-K), the company said it has entered into an agreement with institutional investors for the sale of 902,835 shares of common stock at $2.05/share.Gross proceeds to the company are expected to be ~$1.9M and will be used to "expedite the integration of the recently acquired proprietary FDA-cleared and Medicare-reimbursed Tissue of Origin test."

Vivus ($VVUS) updates investors on its European strategy for Qsymia. The company says it has submitted a request to the EMA for scientific advice on using a "pre-specified interim analysis from [AQCLAIM] to support the resubmission of the marketing authorization application ... under the centralized procedure."Recall that earlier this year, First Manhattan called the centralized procedure "the only pathway that large pharma uses for EU approval of blockbuster drugs," and dubbed the decentralized procedure (which VVUS was at one time considering) "a path to nowhere."

Accuray ($ARAY) trade up after JPMorgan upgrades the stock to Neutral from Underweight and reiterates an $8 PT. Analyst Tycho Peterson: Accuray "has shown continued improvement in orders, aided by recent product introductions (CyberKnife M6, Tomotherapy H series). We expect the upcoming ASTRO conference, where the company will showcase new products and have customers provide initial feedback on the systems, to be a positive event."

AcelRx ($ACRX) move sharply higher on heavy volume. Perhaps helping the cause is an article from SA contributor Stock Matusow who points to a Sufentanil Nanotab NDA as a near-term catalyst. Matusow also likes the company's cash position and isn't shy about the possibility of a takeout: "Based on the rumors we have heard, and comparing these rumors to the past performance of BOD members, we believe the company will be acquired within six months."

Shares of Insulet ($PODD) slip after JMP Securities downgrades the insulin device manufacturer to Perform from Outperform, citing increased reports in the FDA's MAUDE database, negative customer feedback online, and higher-than-expected failure rates.




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