Healthcare Review: MannKind Corporation, Intercept, Adamis Pharmaceuticals, NeoStem, Northwest Biotherapeutics Print E-mail
By Staff and Wire Reports   
Thursday, 29 May 2014 13:50
U.S. stocks rose at the open on Thursday on expectations of strong growth in the second quarter, even as data showed the world's largest economy contracted in the first quarter. Supporting the push to a fresh record high on the S&P 500, the number of Americans filing new claims for unemployment benefits fell more than expected last week, pointing to a strengthening labor market. The Dow Jones industrial average rose 22.41 points, or 0.13 percent, to 16,655.59; the S&P 500 gained 3.67 points, or 0.19 percent, to 1,913.45, and the Nasdaq Composite added 10.27 points, or 0.24 percent, to 4,235.35.

MannKind Corporation (NASDAQ:MNKD)’s shares gained 4.13% to $8.51. The company will present at upcoming conferences. Jefferies 2014 Global Healthcare Conference on June 2, 2014 at 2:30 pm (ET) in New York, New York; Goldman Sachs 35th Annual Global Healthcare Conference on June 12, 2014 at 11:20 am (PT) at the Terranea Resortin Rancho Palos Verdes, California.

The FDA has granted fast-track designation for the use of obethicholic acid (OCA) for treating primary biliary cirrhosis (PBC). Intercept ($ICPT) plans to complete a new drug application for OCA in 1H15. The NDA will include data from Intercept's Phase 3 trial and two randomized Phase 2 trials.

Adamis Pharmaceuticals ($ADMP) submits an NDA for its epinephrine pre-filled single dose syringe (1:1000; 0.3 mg) for the emergency treatment of allergic reactions (Type 1) including anaphylaxis. The company believes its product will be an attractive lower cost substitute versus the more-expensive auto-injectors.

NeoStem ($NBS) does a retrospective pooled analysis of three melanoma clinical trials conducted from 1990 - 2011 and concludes that its Melapuldencel-T autologous immunotherapy may increase Overall Survival (OS) in patients with metastatic melanoma. Carefully parsing the data, the company finds that OS in the Melapuldencel-T cohort was 33% compared to 20% in patients treated with irradiated autologous tumor cells for the subset of patients who still had evidence of disease after prior treatment with one or more standard therapies.

Northwest Biotherapeutics ($NWBO -0.2%) takes umbrage with TheStreet's Adam Feuerstein in response to his May 27 article asserting that the company's DCVax isn't working. He says the company's stated maximum tumor shrinkage of 28% in some Phase 1 trial patients falls short of the globally-accepted RECIST standard of at least a 30% reduction to qualify as a valid partial response.




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