A few biopharmaceutical stocks met the weekend headache-free after clinical and regulatory updates, but medical device companies weren't immune to investor skepticism about issues ranging from product panels to accounting practices.
Of the winners,
said Friday that it plans to submit a response to the approvable letter it received from the Food and Drug Administration for migraine drug Trexima on Aug. 1, within the next ten days.
Pozen and partner
met jointly with the FDA to discuss the proposed plan for responding to the approvable letter.
The company said the submission will include clarifying non-clinical information regarding Trexima's genotoxicity and a routine clinical safety update. Pozen said it's requesting an expedited review, but the FDA may take up to six months. Pozen shares rose $1.37, or 14.4%, to $10.91, helping to boost the Nasdaq Biotechnology Index, which was up 15.06, or 1.7%, to 883.51.
climbed after announcing promising interim results from an ongoing phase Ib study on Zybrestat for patients with advanced solid tumors.
Based on results from the first two of three dose cohorts in the study -- which had six evaluable patients each -- OxiGene said the Zybrestat-Avastin combination appeared safe and well-tolerated, resulting in significantly enhanced tumor blood-flow reductions, and demonstrated early evidence of clinical activity in the absence of concurrent cytotoxic chemotherapy.
Shares rose 9 cents, or 2.4%, to $3.78.
Then, after saying Friday that its lipid-lowering 301012 was effective in reducing LDL cholesterol,
said the drug candidate was also shown to be safe in an extension study of patients with inherited high LDL cholesterol.
Shares climbed 51 cents, or 3.3%, to $16.
Others stocks greeted the weekend with less enthusiasm.
gave up $1.10, or 1.9%, to $55.90, on speculation about an upcoming FDA panel regarding its Endeavor stent. The FDA was specifically concerned about a study in which Medtronic's device fell shy in some respects to
Johnson & Johnson's
drug-coated Cypher stent and
Boston Scientific also sent
shares lower when it revealed in a
Securities and Exchange Commission
filing that it disposed of its 3.57 million shares of Cyberonics common stock for $13.60 a piece. Cyberonics fell 50 cents, or 3.3%, to $14.63, and Boston Scientific gained 34 cents, or 2.4%, to $14.26.
an orthopedic device maker, said Thursday after the close that it defaulted on its credit agreement and could have to restate financial documents dating back to 2003 due to possible flawed accounting at its Sheffield, U.K., unit. The company estimates that Sheffield, which it acquired in 2003, overstated revenue by $12 million to $16 million over the past nine years. Shares declined $1.05, or 5.9%, to $16.69.