Morning Movers 6/8: ANPI, MITI, KERX, DYAX, MSPD, MNKD Higher; AIB, LYG, XTNT, IRE Lower
Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI) 50% HIGHER; announced that the U.S. FDA has granted 510(k) clearance for the Option(TM) Inferior Vena Cava Filter in the United States, for use in both permanent and retrievable indications. Click here for the full report.
Micromet, Inc. (Nasdaq: MITI) 31% HIGHER; last week presented an update from an ongoing clinical study of the BiTE(R) antibody blinatumomab (MT103) for non-Hodgkin's lymphoma at the 14th Congress of the European Hematology Association, held June 4 to 7 in Berlin, Germany. Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells. Click here for the full report.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) 26.9% HIGHER; announced positive results of the Phase 2 study of Zerenex for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on thrice weekly hemodialysis. Here is more color.
Dyax Corp. (NASDAQ: DYAX) 17.7% HIGHER; announced today that the FDA has accepted for review the Company’s submission in response to the FDA’s March 2009 Complete Response letter which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema. The FDA assigned Dyax's BLA a new Prescription Drug User Fee Act action date of December 1, 2009.
Allied Irish Banks (NYSE: AIB) 13.9% LOWER; S&P cut its long-term sovereign credit rating on the Republic of Ireland from AA+ to AA. The outlook is negative.
Mindspeed Technologies, Inc. (NASDAQ: MSPD) 13.1% HIGHER; raises its Q3 sales guidance from $30-$32 million to $32-$33 million, versus the consensus of $30.67 million. Here is the full report.
Lloyds Banking Group (NYSE: LYG) 10.7% LOWER; see Allied Irish Bansks.
XTENT (Nasdaq: XTNT) 10.3% LOWER; correcting today following last week's 500%+ surge on news that it received conditional approval from the US FDA for an Investigational Device Exemption authorizing it to begin its pivotal clinical program, composed of two pivotal trials called CUSTOM IV and CUSTOM IV Angio to support the approval in the United States of its Custom NX(R) Drug Eluting Stent System.
Bank of Ireland (NYSE: IRE) 9.6% LOWER; see AIB.
MannKind's (Nasdaq: MNKD) 9.5% HIGHER; AFRESA(R) (insulin human [rDNA origin]) Inhalation Powder is a well-tolerated, ultra rapid acting insulin with changes in pulmonary function tests comparable to usual antidiabetic treatment, according to data presented today at the American Diabetes Association's 69th Scientific Sessions. Results from the prospective, multicenter, phase 3 study conducted over a two-year period showed no difference in mean change in forced expiratory volume in one second (FEV(1)) between those treated with AFRESA and those treated with standard insulin therapy. Click here for the full report.
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) 9.4% HIGHER; announced a late-breaking poster presentation of positive results from BLOOM, the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management, at the American Diabetes Association's 69th Scientific Sessions. Lorcaserin patients achieved highly significant categorical and absolute weight loss in Year 1, and continued treatment with lorcaserin in Year 2 helped significantly more patients maintain their weight loss as compared to those on placebo. Treatment with lorcaserin also resulted in highly significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk. Lorcaserin did not result in increased risk of depression and was not associated with the development of cardiac valvular insufficiency.
Diodes Incorporated (Nasdaq: DIOD) 8.7% HIGHER; today increased its guidance for Q2. Due to continued improvement in demand and order rates, primarily in Asia, the Company is raising its Q2 sales outlook from up 14-22% to up 22-30%. The Company is also raising its guidance for gross margin and now expects Q2 gross margin to be approximately 24-28% versus the prior guidance of 20-24%. The revenue increase is driven primarily by demand for the Company's products utilized in equipment such as LCD televisions and panels, set-top boxes, mobile handsets and netbooks as well as the production ramp up of previous design wins, which are leading to market share gains. Click here for the full report.
Delcath Systems, Inc. (Nasdaq: DCTH) 8.3% HIGHER; announced today that it has achieved the 75% enrollment point of its pivotal Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver. The participating cancer centers in this trial continue to evaluate and enroll patients and the Company remains on target to complete enrollment this year. Click here for the full report.
StemCells, Inc. (NASDAQ: STEM) 8% HIGHER; announced positive results from the first Phase I clinical trial of its proprietary HuCNS-SC product candidate (purified human neural stem cells), including demonstration of a favorable safety profile along with evidence of engraftment and long-term survival of the HuCNS-SC cells. Click here for the full report.
Get This Report Daily Here: http://www.streetinsider.com/entities/StreetInsider.com+Morning+Movers.
Micromet, Inc. (Nasdaq: MITI) 31% HIGHER; last week presented an update from an ongoing clinical study of the BiTE(R) antibody blinatumomab (MT103) for non-Hodgkin's lymphoma at the 14th Congress of the European Hematology Association, held June 4 to 7 in Berlin, Germany. Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells. Click here for the full report.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) 26.9% HIGHER; announced positive results of the Phase 2 study of Zerenex for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on thrice weekly hemodialysis. Here is more color.
Dyax Corp. (NASDAQ: DYAX) 17.7% HIGHER; announced today that the FDA has accepted for review the Company’s submission in response to the FDA’s March 2009 Complete Response letter which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema. The FDA assigned Dyax's BLA a new Prescription Drug User Fee Act action date of December 1, 2009.
Allied Irish Banks (NYSE: AIB) 13.9% LOWER; S&P cut its long-term sovereign credit rating on the Republic of Ireland from AA+ to AA. The outlook is negative.
Mindspeed Technologies, Inc. (NASDAQ: MSPD) 13.1% HIGHER; raises its Q3 sales guidance from $30-$32 million to $32-$33 million, versus the consensus of $30.67 million. Here is the full report.
Lloyds Banking Group (NYSE: LYG) 10.7% LOWER; see Allied Irish Bansks.
XTENT (Nasdaq: XTNT) 10.3% LOWER; correcting today following last week's 500%+ surge on news that it received conditional approval from the US FDA for an Investigational Device Exemption authorizing it to begin its pivotal clinical program, composed of two pivotal trials called CUSTOM IV and CUSTOM IV Angio to support the approval in the United States of its Custom NX(R) Drug Eluting Stent System.
Bank of Ireland (NYSE: IRE) 9.6% LOWER; see AIB.
MannKind's (Nasdaq: MNKD) 9.5% HIGHER; AFRESA(R) (insulin human [rDNA origin]) Inhalation Powder is a well-tolerated, ultra rapid acting insulin with changes in pulmonary function tests comparable to usual antidiabetic treatment, according to data presented today at the American Diabetes Association's 69th Scientific Sessions. Results from the prospective, multicenter, phase 3 study conducted over a two-year period showed no difference in mean change in forced expiratory volume in one second (FEV(1)) between those treated with AFRESA and those treated with standard insulin therapy. Click here for the full report.
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) 9.4% HIGHER; announced a late-breaking poster presentation of positive results from BLOOM, the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management, at the American Diabetes Association's 69th Scientific Sessions. Lorcaserin patients achieved highly significant categorical and absolute weight loss in Year 1, and continued treatment with lorcaserin in Year 2 helped significantly more patients maintain their weight loss as compared to those on placebo. Treatment with lorcaserin also resulted in highly significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk. Lorcaserin did not result in increased risk of depression and was not associated with the development of cardiac valvular insufficiency.
Diodes Incorporated (Nasdaq: DIOD) 8.7% HIGHER; today increased its guidance for Q2. Due to continued improvement in demand and order rates, primarily in Asia, the Company is raising its Q2 sales outlook from up 14-22% to up 22-30%. The Company is also raising its guidance for gross margin and now expects Q2 gross margin to be approximately 24-28% versus the prior guidance of 20-24%. The revenue increase is driven primarily by demand for the Company's products utilized in equipment such as LCD televisions and panels, set-top boxes, mobile handsets and netbooks as well as the production ramp up of previous design wins, which are leading to market share gains. Click here for the full report.
Delcath Systems, Inc. (Nasdaq: DCTH) 8.3% HIGHER; announced today that it has achieved the 75% enrollment point of its pivotal Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver. The participating cancer centers in this trial continue to evaluate and enroll patients and the Company remains on target to complete enrollment this year. Click here for the full report.
StemCells, Inc. (NASDAQ: STEM) 8% HIGHER; announced positive results from the first Phase I clinical trial of its proprietary HuCNS-SC product candidate (purified human neural stem cells), including demonstration of a favorable safety profile along with evidence of engraftment and long-term survival of the HuCNS-SC cells. Click here for the full report.
Get This Report Daily Here: http://www.streetinsider.com/entities/StreetInsider.com+Morning+Movers.
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