ESPR On Track, INSY Gets FDA Date, It's A Thumbs Up For SGEN, RPTP

(RTTNews) - BioLineRx Ltd. (BLRX) has initiated a phase 2b trial for BL-8040 as a novel consolidation treatment for acute myeloid leukemia, and the study will enroll up to 194 patients, randomized in 1:1 ratio, at up to 25 sites in Germany.

A phase 2 study of BL-8040 for treating relapsed and refractory acute myeloid leukemia patients is underway, and topline results from this study are expected in the fourth quarter of 2015.

BLRX closed Monday's trading at $1.59, up 5.30%.

ContraFect Corp. (CFRX) has been granted Fast Track designation by the FDA for CF-301, currently in a phase 1 clinical trial, for the treatment of Staph aureus bloodstream infections, including methicillin-resistant Staphylococcus aureus, or MRSA. The company expects to complete the study by the end of this year.

If the results are favorable, ContraFect plans to advance CF-301 into a phase 2 study next year in patients with staph bloodstream infections, including MRSA.

The company went public last July, offering its shares at a price of $6 each. The stock closed Monday's trading at $5.39, up 18.21%.

Esperion Therapeutics Inc. (ESPR) remains on track to initiate a phase III development program with ETC-1002, an investigational, once-daily LDL-C lowering small molecule designed to lower levels of LDL-C and to avoid side effects associated with existing LDL-C lowering therapies, by the end of 2015.

Based on feedback from the FDA, the company announced that the approval of ETC-1002 in the HeFH (heterozygous familial hypercholesterolemia) and ASCVD (clinical atherosclerotic cardiovascular disease) patient populations will not require the completion of a cardiovascular outcomes trial, or CVOT.

However, the company continues to plan and initiate a CVOT prior to NDA filing to pursue broader label indications related to cardiovascular disease risk reduction.

In the fourth quarter, Esperion plans to finalize development plans for the fixed-dose combination of ETC-1002 and Ezetimibe and will file a separate Investigational New Drug application with the FDA.

ESPR closed Monday's trading at $75.51, up 14.10%. In after hours, the stock gained another 10.65% to $83.55.

InSite Vision Inc.'s (INSV.OB) New Drug Application for BromSite for the proposed treatment of inflammation and prevention of ocular pain in the post-cataract surgery setting has been accepted for review by the FDA.

The regulatory agency's decision date is set for April 10, 2016.

Insite signed an agreement with QLT Inc. (QLTI) (QLT.TO) in June of this year, under which QLT will acquire InSite in an all-stock transaction.

INSV.OB closed Monday's trading at $0.22, up 2.30%.

Insys Therapeutics Inc.'s (INSY) New Drug Application for its proprietary Dronabinol Oral Solution has been accepted for filing by the FDA.

The company is seeking approval of Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

The FDA's decision is set for April 1, 2016, which reflects a Standard Review by the regulatory agency.

INSY closed Monday's trading at $36.10, up 3.26%.

Kite Pharma Inc.'s (KITE) phase 1/2 clinical trial of KTE-C19 in patients with refractory aggressive non-Hodgkin's lymphoma who have failed prior chemotherapy treatments and have a poor prognosis is underway. The top-line data from the phase 1 portion of the trial are scheduled to be presented in December.

The company is also on track to transition to the phase 2 portion of the trial later this year.

KITE closed Monday's trading at $60.32, up 4%.

Raptor Pharmaceutical Corp.'s (RPTP) PROCYSBI has received FDA approval for its expanded use in treating children two to six years of age with nephropathic cystinosis.

Procysbi was initially approved in 2013 for the management of nephropathic cystinosis in children and adults.

The global net product sales for PROCYSBI were $69.5 million in 2014, and the company expects the drug to generate revenue of $80-$90 million in 2015.

PRTP closed Monday's trading at $13.48, up 1.81%.

Seattle Genetics Inc.'s (SGEN) ADCETRIS has received FDA approval for the treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. This is the third indication for ADCETRIS in the U.S.

ADCETRIS has already been approved for the treatment of patients with classical HL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT and for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen.

ADCETRIS sales were $104.0 million in the six months ended June 30, 2015 compared to $83.5 for the year-to-date period in 2014, an increase of 25%.

Looking ahead, Seattle Genetics anticipates revenues from ADCETRIS net product sales in the U.S. and Canada to be in the range of $210 million to $220 million in 2015.

SGEN closed Monday's trading at $46.45, up 5.57%. In after hours, the stock was up another 3.34% at $48.00.

Tobira Therapeutics Inc. (TBRA) has initiated a phase IIa study of Cenicriviroc, dubbed ORION, in obese adults with prediabetes or diabetes and suspected non-alcoholic fatty liver disease.

The primary outcome of ORION will measure changes in insulin sensitivity in peripheral and adipose tissue over a 24-week period and will include an interim analysis at 12 weeks.

The interim data from the trial are expected in the first half of 2016.

A phase 2b study of Cenicriviroc, dubbed CENTAUR, in patients with non-alcoholic steatohepatitis has completed enrollment, and the primary endpoint of the trial is scheduled to be reported in the third quarter of 2016.

TBRA closed Monday's trading at $13.30, down 1.92%.