ARIAD Pharmaceuticals Inc. (ARIA) has initiated a phase II trial of its leukemia drug Iclusig in adult patients with metastatic and/or unresectable gastrointestinal stromal tumors. The trial is designed to enroll about 45 patients and will be conducted at three investigational sites in the United States namely, Dana Farber Cancer Institute, Fox Chase Cancer Center and Oregon Health Science University.
Iclusig won FDA approval to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases, last December.
ARIA closed Tuesday's trading 1.01% higher at $18.94.
Biota Pharmaceuticals Inc. (BOTA) has initiated a phase II clinical trial of Laninamivir octanoate for the treatment of influenza in adults. The company expects to have top-line data from this trial in mid-2014.
BOTA closed Tuesday's trading at $3.50, down 1.96%.
Cerus Corp. (CERS) has initiated patient enrollment in two European Phase III clinical trials for its INTERCEPT System for red blood cells, which would support CE Mark registration. One trial is being conducted for patients with acute anemia, and a separate trial is being conducted for patients with chronic anemia.
The INTERCEPT Blood System is meant to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood.
The device is designed for three blood components namely, platelets, plasma and red blood cells.
The INTERCEPT Blood System for platelets and plasma has received CE marks and are being marketed in a number of countries in Europe, CIS (The Commonwealth of Independent States), the Middle East and selected countries in other regions around the world.
CERS closed Tuesday's trading at $4.84, down 1.43%.
Clovis Oncology (CLVS) has priced an underwritten public offering of 3.33 million shares of its common stock at $72.00 per share. The size of the offering has been upsized from $170 million to $240 million. In addition, the underwriters have a 30-day option to purchase up to an additional 486,110 shares of common stock from Clovis Oncology to cover over-allotments, if any.
The offering is expected to close on June 17, 2013.
CLVS closed Tuesday's trading 2.30% higher at $74.83.
Enzo Biochem Inc. (ENZ) has entered into an $8 million senior secured revolving line of credit that may be increased to $12 million with Healthcare Finance Group LLC (HFG). The financing is designed to provide the company with growth capital in a non-dilutive manner.
ENZ closed Tuesday's trading at $2.19, down 3.52%.
MannKind Corp. (MNKD) touched another new 52-week high on Tuesday in the run up to the publication of phase III results of its diabetes candidate Afrezza. The company expects to release data from the study later this summer.
MNKD touched a 52-week high of $8.06 on Tuesday before closing at $7.65.
Medicago Inc. (MDG.TO) has received clearance from Health Canada to initiate its phase II dose-sparing clinical trial for an H5N1 Avian Influenza VLP vaccine candidate. The company expects interim results from the trial in the summer of 2013.
The year 2013 is an important one for NovaBay Pharmaceuticals Inc. (NBY) as clinical results from three of its Auriclosene phase II trials - in urology, dermatology, and ophthalmology, are expected in the second half of the year.
NBY lost 2.96% on Tuesday to close at $1.31.
PDL BioPharma Inc. (PDLI) said it expects royalty revenue guidance for the second quarter ending June 30, 2013, of about $143 million, which represents a 14% increase over the royalty revenue reported in the second quarter of 2012. The forecasted growth in royalty revenues is driven by increased first quarter 2013 sales for all licensed products for which PDL receives royalties in the second quarter of 2013.
PDLI shed 0.38% to close Tuesday's trading at $7.90.
Questcor Pharmaceuticals Inc. (QCOR) rose as much as 36% in intraday trading on Tuesday after the company announced it has acquired rights to develop Synacthen and Synacthen Depot in the U.S. from Novartis Pharma AG and Novartis AG. The products are approved outside the U.S. for certain autoimmune and inflammatory conditions, but have never been developed or approved for patients in the U.S.
Synacthen, a synthetic version of anti-inflammatory hormone Adrenocorticotropic hormone, or ACTH, has been perceived as a competitive threat to Questcor's flagship product Acthar Gel, which is a highly purified preparation of the naturally occurring ACTH.
The acquisition is said to expand Questcor's presence in inflammatory and autoimmune disorders, provide foundation for next generation melanocortin receptor agonist therapeutics, initiate a global footprint, diversify business and enhance long-term growth prospects.
QCOR closed Tuesday's trading at $42.11, up 14.72%.
The FDA will be convening an Advisory Committee to review the Supplemental New Drug Application for Relistor Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain.
Relistor is under license to Salix Pharmaceuticals Ltd. (SLXP) and Ono Pharmaceutical from Progenics Pharmaceuticals (PGNX).
Relistor subcutaneous injection was approved in the United States in 2008 for the treatment of opioid-induced constipation, or OIC, in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
The Supplemental New Drug Application for Relistor seeking approval for the additional indication of treating opioid-induced constipation in patients with chronic pain was issued a complete response letter last July.
The FDA's decision to seek input from an Advisory Committee on the Relistor Supplemental New Drug Application is in response to Salix Pharma's formal appeal of the complete response letter.
SLXP touched an all-time high of $65.92 on Tuesday before closing at $65.42.
Vermillion Inc.'s (VRML) lead diagnostic, OVA1, a blood test for pre-surgical assessment of tumors for malignancy, may be useful in identifying women who should be referred to a gynecologic oncologist, according to the Society of Gynecologic Oncology, or SGO. The OVA1 test along with physician clinical assessment may improve detection rates of malignancies among women with pelvic masses planning surgery, adds the SGO.
OVA1 received FDA clearance in 2009.
VRML gained 2.65% on Tuesday to close at $3.10.
by RTT Staff Writer
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