Apr 21, 2016

Posted by in Biotech Stocks | 0 Comments

Stocks Trending Alert: BioMarin Pharmaceutical Inc (NASDAQ:BMRN), Cara Therapeutics Inc (NASDAQ:CARA), Celldex Therapeutics Inc (NASDAQ:CLDX)

Stocks Trending Alert: BioMarin Pharmaceutical Inc (NASDAQ:BMRN), Cara Therapeutics Inc (NASDAQ:CARA), Celldex Therapeutics Inc (NASDAQ:CLDX)

BioMarin Pharmaceutical Inc (NASDAQ:BMRN) surged +3.40% and ended at $89.31. The total traded volume was 3.92 million shares and market capitalization arrived at $14.33 billion. The stock has a 52-week high price of $151.75 and its 52-week low was recorded at $62.12, while during last trade its minimum price was $88.00 and it gained the highest price of $92.81.

BioMarin Pharmaceutical Inc (NASDAQ:BMRN) on April 20, 2016 announced preliminary data from an ongoing Phase 1/2 clinical trial with BMN 270, an investigational gene therapy treatment for hemophilia A.  A total of eight patients with severe hemophilia A received a single dose of BMN 270, six of whom have been treated at the highest dose of 6 x 1013 vg/kg, and to date, post-treatment follow-up ranges from five to 16 weeks.  At last observation, patients at the highest dose experienced increasing Factor VIII activity levels ranging between 4% and 60% (as a percentage calculated based on the numbers of International Units (IU) per milliliter of whole blood), with five of six patients treated at the high dose now over 5% and two of six at over 50%.  All high dose patients improved from severe to either moderate, mild or normal range in terms of factor levels based on World Federation of Hemophilia criteria.

Liver function tests have been monitored closely during the course of the trial.  The first three patients were not administered prophylactic corticosteroids.  Two of these patients experienced elevated alanine aminotransferase (ALT) levels.  Patient 3, the first patient treated at the highest dose level, experienced a mild ALT elevation at week 4, which prompted administration of a course of corticosteroids. ALT levels in this patient continued to rise modestly during the corticosteroid therapy, which was completed at week 14.  Two weeks later a new corticosteroid regimen was initiated when ALT levels became minimally abnormal for the first time.  The expression of Factor VIII continued to increase during this elevation of ALT and is currently at 57%.  In addition, 28 weeks after dosing, Patient 1 treated at the lowest dose experienced a rise in ALT level to 128 IU/L, although this patient had never documented Factor VIII expression above 1%.  After the third patient, all patients were to be started on prophylactic corticosteroid therapy and to date no further patients have experienced abnormal ALT levels.  BioMarin plans to discuss these findings with UK regulatory authorities prior to dosing the remaining patients.

Cara Therapeutics Inc (NASDAQ:CARA) reported the decrease of -6.57% to close at $7.68 with the overall traded volume of 3.20 million shares. Its market capitalization on last close reached to $211.90 million. The company has the total of 27.25 million outstanding shares. Its intraday-low price was $7.45 and its hit its day’s highest price at $9.00.

Cara Therapeutics Inc (NASDAQ:CARA) on April 20, 2016 announced that it has received notice from the U.S. Food and Drug Administration (FDA) that it has removed the clinical hold on its adaptive Phase 3 trial of I.V. CR845 for postoperative pain.

The clinical hold was triggered by a protocol-specified stopping criterion, based on elevated serum sodium levels, that was met during the first phase of the study. A subsequent review of unblinded safety data from the first 90 patients dosed was completed by Cara, the study’s Independent Data Monitoring Committee (IDMC), and the FDA.

The results of this safety data review confirmed that increases in serum sodium levels in CR845-treated patients beyond the normal range were dose-dependent and asymptomatic with the lowest frequency of events found in the 1 ug/kg I.V. CR845 group. Based on this safety review and an analysis of efficacy trends, the study will continue as a three-arm trial testing two doses of CR845 (1 ug/kg and 0.5 ug/kg) versus placebo.

Celldex Therapeutics Inc (NASDAQ:CLDX) settle at $4.00. Its total traded volume during last trading session was 3.19 million shares. The overall market worth of this company is about $358.92 million. The 52 week range of the stock remained $2.96 – $30.28, while its day’s lowest price was $3.95 and its hit its day’s highest price at $4.10. The beta of this stock currently stands at 3.16.

Celldex Therapeutics Inc (NASDAQ:CLDX) on April 20, 2016 announced three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans. The Company previously reported on four poster presentations at AACR, which included Phase 1 safety and immune response data from the ongoing study evaluating varlilumab and nivolumab in patients with advanced cancers. New presentations included data enhancing the understanding of glembatumumab vedotin’s mechanism of action and further validation of the overexpression of its target, gpNMB, in a wide range of tumor types. Additionally, the Company also presented research with lead agonist antibodies targeting the CD40 receptor, a promising target for immunotherapy, in a poster titled “Development and characterization of novel CD40 antibody agonists for cancer immunotherapy.”

Found on antigen presenting cells, such as dendritic cells, macrophages and B cells, CD40 is a key activator of immune responses. The Company has characterized two fully human antibodies that demonstrated potent agonist activity, such as activating human dendritic cells and B cells and indirectly inducing T cell proliferation. Importantly, Fc receptor interaction, which could cause signal amplification and is required for some CD40 agonist antibodies in development, was not required for agonist ability, enabling controlled, sensitive activation of CD40. Additionally, the drug candidates were shown to upregulate CD95/Fas, a receptor involved in apoptosis, on B cell lymphoma cell lines and to mediate potent anti-tumor activity against the lymphomas in vivo.


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