Nano cap IsoRay (ISR +29.2%) is up on double average volume on no news. The stock made a similar move on October 7 but couldn't hold the gain. Shares reversed off the high of $2.12 all the way down to $1.22 on October 16.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion that Ariad Pharmaceuticals' (ARIA -0.4%) Iclusig (ponatinib) can continue to be used in accordance with its already approved indications for the treatment of certain leukemias and its benefit-risk profile continues to be positive for these indications.
The committee also recommended revised labeling to include additional warnings about the risk of vascular events.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the label expansion of Xtandi (enzalutamide) to include the treatment of adult men with metastatic castrate-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.
CHMP's positive recommendation is based on the Phase 3 Prevail study where enzalutamide reduced the risk of death by 29% compared to placebo. Treated patients also experienced a 17-month delay in the time to initiation of chemotherapy versus placebo.
Xtandi's current indication is for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.
Nano cap protective gear maker Lakeland Industries (LAKE -0.1%) raises $11.2M in a private placement of common stock at $10 per share. Proceeds will be used to pay off an existing loan and for working capital and general corporate purposes. Shares currently trade hands for $15.25.
Lakeland is a member of the Ebola Small Cap Index because of the potential upside demand for its HAZMAT suits. Before the Ebola news onslaught, shares traded for ~$6. Prices peaked at $29.55 on October 14.
Recent IPO Vitae Pharmaceuticals (NASDAQ:VTAE) is up 33% premarket on higher-than-normal volume in response to its announcement of results from a Phase 1 trial of its BACE inhibitor, VTP-37948, in Alzheimer's patients. The drug candidate appeared safe and tolerable. Partner Boehringer Ingelheim expects to initiate more Phase 1 studies to clarify the pharmacokinetic profile and ascending dose characteristics.