Apr 20, 2016

Posted by in Biotech Stocks | 0 Comments

Stocks Under Consideration: Celldex Therapeutics Inc (NASDAQ:CLDX), MannKind Corporation (NASDAQ:MNKD), Stem Cells Inc (NASDAQ:STEM)

Stocks Under Consideration: Celldex Therapeutics Inc (NASDAQ:CLDX), MannKind Corporation (NASDAQ:MNKD), Stem Cells Inc (NASDAQ:STEM)

Celldex Therapeutics Inc (NASDAQ:CLDX) plunged -9.09% and ended at $4.00. The total traded volume was 5.13 million shares and market capitalization arrived at $374.39 million. The stock has a 52-week high price of $30.28 and its 52-week low was recorded at $2.96, while during last trade its minimum price was $3.99 and it gained the highest price of $4.48.

Celldex Therapeutics Inc (NASDAQ:CLDX) on April 18, 2016 announced new safety and immune response data from the Phase 1 portion of a Phase 1/2 dose escalation and cohort expansion study examining the investigational combination of varlilumab, Celldex’s CD27 targeting investigational immune-activating antibody, and Bristol-Myers Squibb’s anti-PD-1 immunotherapy Opdivo® (nivolumab). The data were presented in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans. The Phase 1 portion of the study, conducted in patients with solid tumors, has completed enrollment (n=36) and primarily enrolled patients with colorectal (n=20) and ovarian cancer (n=8). The primary objective of the Phase 1 portion of the study was to evaluate the safety and tolerability of the combination. The Phase 2 portion of the study is open to enrollment.

Key Highlights:

  • Combining the potent immune activator, varlilumab, with the PD-1 inhibitor, nivolumab, showed acceptable tolerability and safety across all dose levels without any evidence of increased autoimmunity or inappropriate immune activation.
  • Combination therapy led to marked changes in the tumor microenvironment including increased infiltrating CD8+ T cells and increased PD-L1 expression, which have been shown to correlate with a greater magnitude of treatment effect from checkpoint inhibitors in other clinical studies.
    • Additional favorable immune biomarkers, such as increase in inflammatory chemokines and decrease in T regulatory cells, were also noted.
  • In a subset of patients (n=17) on study who had both pre- and post-tumor biopsies available, preliminary evidence suggest a correlation between biomarker data and stable disease or better in seven of these patients (4 ovarian cancer, 2 colorectal cancer, 1 squamous cell carcinoma of the head and neck).

MannKind Corporation (NASDAQ:MNKD) reported the decrease of -5.29% to close at $1.61 with the overall traded volume of 4.51 million shares. Its market capitalization on last close reached to $715.71 million. Its beta value stands at 1.86 times. The company has the total of 428.85 million outstanding shares. Its intraday-low price was $1.60 and its hit its day’s highest price at $1.75.

MannKind Corporation (NASDAQ:MNKD) on April 19, 2016 announced two senior appointments to its commercial organization.  Joining the Company are Joseph Saldanha as Vice President of Marketing and Agustin (Tino) Quintero as Vice President of Market Value, Access and Trade.  Both will report to Michael Castagna, MannKind’s Chief Commercial Officer.

Mr. Saldanha has worked in the diabetes space for over 13 years, in both U.S. and global roles.  He has experience marketing oral anti-diabetic medications, insulins (both injectable and inhaled), and medical devices.  Mr. Saldanha commercialized Sanofi’s Lantus® in the Intercontinental Region.  After returning to the U.S., he was part of the team that commercialized the Lantus SoloSTAR® pen.  In addition to heading up Sanofi’s strategy and medical education teams, he was responsible for all hospital business.  Mr. Saldanha launched an initiative with Certified Diabetes Educators® to train patients in diabetes and the appropriate use of insulin.  Prior to that, Mr. Saldanha served as Director of Business Development for the insulin delivery device business at Johnson and Johnson Diabetes (LifeScan®/Animas®). More recently, he worked in the biosimilars business with Pfizer in New York.  Mr. Saldanha holds a Bachelor of Science from Drexel University and a Master of Science from the University of Pennsylvania.

Mr. Quintero has 18 years of experience in bio-pharmaceutical market access as well as a proven record of achieving commercial excellence.  He joins MannKind from AbbVie, a global biopharmaceutical company, where he served as National Managed Care Executive.  In this role, Mr. Quintero was responsible for negotiating AbbVie’s portfolio of products (including Humira®) while developing contracting and pricing strategies for hepatitis C, multiple sclerosis and oncology product launches.  Prior to that, he held integral leadership roles in sales and account management at Vertex Pharmaceuticals, including oversight of the commercial launch of Incivek®, their first commercial product. Earlier, he was part of Gilead Sciences and Sandoz’s leadership teams, responsible for sales, product launches and market access for both commercial and government payers.   Mr. Quintero holds a Bachelor of Science in economics from Florida International University.

Stem Cells Inc (NASDAQ:STEM) moved down -1.14% to settle at $0.260. Its total traded volume during last trading session was 4.40 million shares. The overall market worth of this company is about $33.23 million. The 52 week range of the stock remained $0.21 – $0.92, while its day’s lowest price was $0.25 and its hit its day’s highest price at $0.29. The beta of this stock currently stands at 1.14.

Stem Cells Inc (NASDAQ:STEM) on April 18, 2016 announced that Dr. Stephen Huhn, the Company’s Chief Medical Officer and VP of Clinical Research, presented additional details on its ongoing Phase II Pathway™ Study of HuCNS-SC cells for the treatment of chronic cervical spinal cord injuries.  The presentation, which took place at the 2016 American Spinal Injury Association (ASIA) annual meeting in Philadelphia on Friday, April 15, included a top line update for the six patients enrolled in open label Cohort I from the Pathway Study. The 6-month results from Cohort I showed that muscle strength had improved in five of the six patients with four of these five patients also demonstrating improved performance on functional tasks assessing dexterity and fine motor skills. In addition, four of the six patients had improvement in the level of cord injury as measured by ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) assessment. The Company expects to release detailed final 12-month results on this first open-label cohort later this quarter.

 

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