PPHM Soars, IMV Shot Works, ACST Debuts, FOLD Unfolds, BLRX Gains On CLARITY

Peregrine Pharmaceuticals Inc. (PPHM: Quote) soared 80% after the company announced that an internal review of a phase II study of Bavituximab in second-line non-small cell lung cancer supports advancing the compound into phase III development. The review was prompted by the discovery of vial coding discrepancies while preparing for an end of Phase II meeting with the FDA.

The company said it is now preparing for discussions with the FDA and worldwide regulatory agencies.

Thoratec Corp. (THOR: Quote) has received FDA approval to commence a study, dubbed REVIVE-IT, to compare the use of its HeartMate II LVAD with optimal medical management in patients with New York Heart Association Class III heart failure.

Another complementary study known as ROADMAP is currently enrolling patients, and the company expects the full cohort of 200 patients to be enrolled in the ROADMAP study by the end of 2013.

Orexigen Therapeutics Inc. (OREX: Quote) says it expects to resubmit the Contrave NDA in the second half of 2013 with potential approval in early 2014.

The company's lead obesity drug candidate - Contrave, was issued a complete response letter in January of 2011 on cardiovascular safety concerns, and was asked to conduct a cardiovascular outcomes trial for the drug before it could be approved.

Perrigo Co. (PRGO: Quote) has received FDA clearance to manufacture three new infant formula products that will be compliant with the Codex Alimentarius Commission, established by the Food and Agriculture Organization of the United Nations (FAO) and the World health Organization (WHO) to set international food standards. Shares have traded in a 52-week range of $90.18 to $120.78.

Immunovaccine Inc. (IMV.V: Quote) rose more than 10% following positive results from a phase I clinical study of its cancer vaccine, DPX-Survivac, for the treatment of ovarian cancer.

Boehringer Ingelheim and Eli Lilly and Co. (LLY: Quote) reported positive top-line results from four completed phase III clinical trials for Empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT-2) inhibitor being studied for treatment of patients with type 2 diabetes (T2D). The filing for regulatory review in the U.S., Europe and Japan is expected in 2013.

Acasti Pharma Inc. received approval to list its common shares on the NASDAQ Capital Market beginning on January 7, 2013 under the ticker symbol (ACST: Quote). Shares closed 25% higher at $2.70 on Monday.

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PPHM Soars, IMV Shot Works, ACST Debuts, FOLD Unfolds, BLRX Gains On CLARITY