|Healthcare Review: MannKind Corporation, Intercept, Adamis Pharmaceuticals, NeoStem, Northwest Biotherapeutics|
|By Staff and Wire Reports|
|Thursday, 29 May 2014 13:50|
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.