The Dow And The S&P Both Hit New Intraday Highs

U.S. stocks were mixed in a quiet session Thursday as rising hopes about more stimulus in Europe were tempered by a continuing decline in oil prices. The Dow Jones Industrial Average advanced 34 points, or 0.2% to 17518. The S&P 500 index fell less than 0.1% to 2024 and the Nasdaq Composite Index slipped four points, or 0.1%, to 4617.

Akorn, Inc. (NASDAQ:AKRX) drops on a 4x surge in volume after its Q3 earnings report. Earnings and revenue beat consensus, but management softened its non-GAAP 2014 income guidance slightly to $136M - 138M from $134M - 140M despite raising revenue guidance to $630M - 640M from $605 - 625M.

Thinly-traded micro cap Epizyme Inc. (NASDAQ:EPZMgets the rude treatment today in response to its report of preliminary Phase 1 results for EPZ-5676, a selective inhibitor of the DOT1L histone methyltransferase, for the treatment of acute leukemia with alterations in the MLL gene (MLL-r) or partial tandem duplications within MLL.

Thinly-traded nano cap Alexza Pharmaceuticals, Inc. (NASDAQ:ALXAdrops again today after its Q3 results came in shy of expectations. Turnover is 3x normal albeit only 400K shares. Shares are down 63% from the intermediate high of $5.67 on July 16.

Sarepta Therapeutics Inc. (NASDAQ:SRPT) Q3 results: Revenues: $1.1M (-73.8%); R&D Expense: $21.9M (+3.8%); G&A: $12.9M (+61.3%); Operating Loss: ($33.7M) (-35.3%); Net Loss: ($29.2M) (+30.5%); Loss Per Share: ($0.71) (+42.7%); Quick Assets: $236M (-8.2%).

As expected, the FDA's Center for Devices and Radiological Health informs Edap Tms SA (ADR) (NASDAQ:EDAP) that its Ablatherm-HIFU PMA is not approvable in its current form. Consistent with the feedback from the Gastroenterology and Urology Devices Ad Comm meeting, the regulator recommends a modified indication for use in a population of localized prostate cancer patients that have greater risk of morbidity and/or mortality from the cancer. It also made recommendations pertaining to the use of the company's European registry, along with safety data from the U.S. IDE, to support approval for the modified indication. EDAP will have to generate additional data and analyses to comply with the FDA's requests.

Disclosure: This article contains information and opinions based on data obtained from reliable sources, which is current as of the publication date, and does not constitute a recommendation ...

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