ARIAD Pharmaceuticals Inc. (ARIA) said that it expects its leukemia drug Iclusig to be approved in the EU in the second quarter of 2013. Iclusig was approved by the FDA for the treatment of chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) last December.
The company has also filed a Marketing Authorization Application for Iclusig in Switzerland and expects to submit regulatory filings in Canada and Australia in the third quarter of 2013.
ARIA closed Tuesday's trading 1.15% higher at $17.55.
BIOLASE Inc. (BIOL) has entered into an Affiliation Agreement with Sun Dental Laboratories, LLC to form a strategic partnership to sell Trios family of intraoral scanners manufactured by Copenhagen-based 3Shape A/S. BIOLASE is currently a non-exclusive distributor for the Trios IOS in the United States and Canada, and in negotiations for additional distribution internationally.
BIOLASE expects the deal not only to generate incremental sales of Trios IOSs, but also create prospects for its core WaterLase and diode laser products, as well as for its CBCT digital imaging equipment at hundreds of high-tech dental practices.
BIOL closed Tuesday's trading at $5.11, down 3.95%.
BioLineRx Ltd. (BLRX) has a couple of events lined up over the coming months. The company expects to initiate a phase IIa trial of BL-8040 for the treatment of relapsed/refractory acute myeloid leukemia in Q2 2013. Partial results from this trial are expected in Q4 2013 and final results in the second half of 2014.
The company is planning to commence pivotal CE-Mark registration trial of BL-5010 for European approval in the second half of 2013. BL-5010 is being developed for the non-surgical removal of skin lesions.
BioLineRx said that it expects partial results from a phase 1/2 clinical trial of BL-8020 in hepatitis C virus to be reported in Q4 2013 and final results in the first half of 2014.
Though the company has terminated the BL-1020 trial of schizophrenia due to disappointing interim results from a phase 2/3 study, dubbed CLARITY, it is still under review, and a more thorough review of the full unblinded results is expected during Q3 2013.
BLRX closed Tuesday's trading at $1.81, up 2.26%.
Cubist Pharmaceuticals Inc.'s (CBST) late-stage antibiotic candidate ceftolozane/tazobactam has been granted Fast Track status by the FDA in the indications of Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and Complicated Urinary Tract Infections (cUTI).
The FDA granted Fast Track status for ceftolozane/tazobactam in Complicated Intra-Abdominal Infections (cIAI) in February 2013.
Ceftolozane/tazobactam is currently being studied in pivotal phase III trials as a potential intravenous therapy for the treatment of cIAI and cUTI. A phase III VABP program for ceftolozane/tazobactam is expected to be initiated by mid-year.
CBST closed Tuesday's trading at $47.63, down 0.04%.
Isis Pharmaceuticals Inc. (ISIS) intends to offer for sale 9 million shares of its common stock in an underwritten public offering. The terms of the offering are yet to be revealed.
ISIS closed Tuesday's trading at $21.89, down 2.36%.
Keryx Biopharmaceuticals Inc. (KERX) said Tuesday that it is progressing with the U.S. phase II study of its experimental drug Zerenex for the management of phosphorus and iron deficiency in anemic patients with Stages 3 to 5 non-dialysis dependent chronic kidney disease, with top-line results expected in Q3 2013.
KERX closed Tuesday's trading at $7.99, down 3.15%. In after-hours, the stock was up 1.63% at $8.12.
Pivotal Therapeutics Inc. (PVTTF.PK) on Tuesday said that its lead product VASCAZEN demonstrated to be highly effective in correcting an Omega-3 deficiency in patients with cardiovascular disease in a trial. The trial was a randomized, double blind, placebo controlled, multi-center USA based study that enrolled 110 patients.
VASCAZEN is a currently available prescription only Medical Food specifically formulated for the dietary management of an Omega-3 deficiency in cardiovascular patients.
Plandai Biotechnology Inc. (PLPL) has formed a new entity known as Phyto Pharmacare, Inc., to oversee all aspects of developing and marketing Phytofare extracts for pharmaceutical and drug applications.
The company noted that initially, Phyto Pharmacare will focus on using its Phytofare Catechin Extract as both a cure for and prevention of malaria.
PLPL touched a new high of $0.38 on Tuesday before closing at $0.35.
pSivida Corp. (PSDV) announced that ILUVIEN, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema, is now commercially available in Germany. ILUVIEN for the treatment of chronic DME is licensed to Alimera Sciences, Inc., and has received marketing authorization in Austria, France, Germany, Portugal, Spain and the U.K.
PSDV closed Tuesday's trading 1.11% higher at $2.74.
Sarepta Therapeutics Inc. (SRPT) has initiated dosing in a phase 1 multiple ascending dose clinical trial of AVI-7288, its lead drug candidate for the treatment of Marburg virus infection. There are currently no treatments for Marburg virus infection beyond supportive care.
SRPT closed Tuesday's trading at $31.22, down 2.04%.
Seattle Genetics Inc. (SGEN) plans to initiate a phase 1/2 clinical trial of ADCETRIS in combination with bendamustine for second-line hodgkin lymphoma patients by mid-2013 and a phase II frontline trial of ADCETRIS in combination with Rituxan and standard chemotherapy (R-CHOP) for patients with diffuse large B-cell lymphoma in the second half of 2013.
The other upcoming milestones for this year are initiation of a phase 1 trial of SGN-CD33A for acute myeloid leukemia and submission of an IND application to the FDA for SGN-LIV1A.
SGEN closed Tuesday's trading at $35.41, down 2.53%.
Trius Therapeutics Inc. (TSRX) plans to file a New Drug Application for tedizolid phosphate for acute bacterial skin and skin structure infection, or ABSSSI, in the second half of 2013. The company also intends to initiate a phase III program of tedizolid phosphate for the treatment of pneumonia in the second half of 2013, pending final agreement with regulatory authorities.
TSRX shed 2.52% on Tuesday to close at $6.58.
Targacept Inc. (TRGT) expects to report top-line results from a phase IIb clinical trial of TC-5619 in negative symptoms and cognitive dysfunction in schizophrenia by the end of this year. Top line results from a phase IIb study of TC-1734 in mild to moderate Alzheimer's disease are expected in mid-2014.
TRGT closed Tuesday's trading 6.69% higher at $5.10.
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Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.