FDA based news moving small caps Print E-mail
By Staff and Wire Reports   
Friday, 12 August 2011 11:18
A few healthcare stocks are rising despite the mixed bag of economic signals which are confounding traders already dizzy from a week of record-setting gains and losses.

Shares of MannKind Corporation (NasdaqGM: MNKD) are rising after they announced that they have confirmed with the US Food and Drug Administration (FDA) the design of the clinical trials for its diabetes candidate, Afrezza. 

The company says that it has worked with the Food and Drug Administration on the design of two clinical trials for Afrezza, a fast-acting insulin treatment inhaled through a device designed by the company. The development follows two rejected applications to the FDA to sell the product. In the complete response letter (CRL) issued in January 2011, the regulatory body had asked MannKind to conduct two trials of Afrezza, one in patients with type I diabetes and one in patients with type II diabetes. 

JMP Securities has just upgrades MannKind to "Market Outperform" seeing a possible double in share price for their target.

In other news, shares of TapImmune Inc. (OTCBB:TPIV.OB) are up over 15% after the company announced their FDA IND approval. After years in the lab, the technology will finally move into human testing and the company is set to sponsor a Phase I HER-2/neu targeted therapeutic vaccine trial in HER-2/neu positive breast cancer patients at the Mayo Clinic.

The human trials stem from a technology license option and sponsored research agreements between Mayo Clinic and TapImmune and is based on research on novel immunogenic peptide epitopes of the HER-2/neu antigen discovered in breast cancer patients with pre-existing immunity to HER-2/neu. The trial is jointly led by Keith Knutson, Ph.D and Amy Degnim, M.D. Mayo Clinic.

Staff members at the Mayo clinic are excited about the technology and According to Dr Knutson, "HER-2/neu is associated with aggressiveness in breast cancer and in our preclinical mouse studies we found that boosting HER-2/neu-specific immunity blocks tumor growth. In the planned human clinical trial, the goal will be to determine whether we can also boost immunity to HER-2/neu in patients, hopefully paving the way to asking whether vaccination blocks tumors in humans."

The news marks an important milestone for the company, whose unique approach is designed to increase the efficacy of vaccines by enhancing antigen presentation through the use of the Transporter of Antigen Processing ('TAP'). We told our readers about this forward looking trade opportunity recently and we continue to expect more positive news in the coming days as it relates TPIV's TAP-based prophylactic vaccine which initial tests indicate may increase the efficacy of targeted prophylactic vaccines by up to 1000 times.

TapImmune's TAP technology could significantly improve the efficacy of many current prophylactic vaccines and enhance the creation of new ones in the fight against many pandemic infectious diseases. A next generation smallpox vaccine is currently in preclinical development and we continue to expect good news development on that front for the company as well.

Here is a snapshot of other market movers this Friday:

Gainers (% price change) Last Trade Change Mkt Cap
MannKind Corporation MNKD 2.90 +0.53 (22.36%) 379.81M
Delcath Systems, Inc. DCTH 4.05 +0.45 (12.50%) 174.78M
YM BioSciences Inc. (USA) YMI 2.02 +0.22 (12.22%) 223.06M
Keryx Biopharmaceuticals KERX 3.54 +0.30 (9.10%) 244.20M
Amarin Corp. plc (ADR) AMRN 13.20 +1.05 (8.64%) 1.68B
Losers (% price change)  
Cytori Therapeutics Inc CYTX 2.97 -0.26 (-7.93%) 156.05M
AVANIR Pharmaceuticals AVNR 2.78 -0.20 (-6.71%) 344.98M
Corcept Therapeutics Inc. CORT 2.79 -0.13 (-4.45%) 234.28M
Progenics Pharmaceuticals PGNX 6.04 -0.26 (-4.13%) 202.60M
Chindex Intl., Inc. CHDX 10.50 -0.45 (-4.11%) 173.10M
Most Actives (dollar volume)  
Pfizer Inc. PFE 17.90 +0.09 (0.51%) 141.43B
Johnson & Johnson JNJ 63.46 +0.02 (0.03%) 173.95B
Merck & Co., Inc. MRK 31.51 +0.31 (0.99%) 97.26B
Abbott Laboratories ABT 49.52 +0.14 (0.28%) 77.08B
Cephalon, Inc. CEPH 79.95 +0.38 (0.48%) 6.23B

 




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