|Healthcare Review: MannKind, Vanda Pharmaceuticals, OncoSec Medical, MiMedx, HeartWare International|
|By Staff and Wire Reports|
|Wednesday, 04 June 2014 12:39|
Shares of MannKind ($MNKD) are up again today on increased volume. Prices have now increased ~168% from the March 31 low of $3.80. The pre-PDUFA (July 15) run-up is being goosed by an expected announcement of a marketing partner.This might be a superb time for profit-taking, however. Prices are extended 35% over the 10-week EMA and money flow is tepid. In addition, the number of mutual funds with positions has dropped to 146 from 152 a year earlier. This is a clear signal for retail investors.
Shares of Vanda Pharmaceuticals ($VNDA) pop on increased volume in response to yesterday's announcement that the EMA accepted its MAA for Hetlioz.
In a registered direct offering, OncoSec Medical ($ONCS -10.5%) agrees to sell 22,535,212 shares of common stock at $0.71/share to institutional investors. The investors will also receive warrants to purchase up to an aggregate of 7,887,325 shares of common at $0.90/share for a term of five years. Net proceeds will be ~$15M and will be used for general corporate purposes including funding clinical trials and R&D.
MiMedx ($MDXG) reports that the SEC has dropped its civil action against Chairman and CEO Pete Petit. The regulator brought the action against him in 2007 alleging that as Chairman and CEO of Matria Healthcare he provided insider information to a friend who subsequently purchased Matria Healthcare stock. The case did not involve MiMedx in any way.
The FDA sends HeartWare International ($HTWR) a warning letter after it conducted an on-site inspection of the company's Miami Lakes manufacturing facility in January. The notification cites four deficiencies the company needs to address: procedures for validating device design, including labeling; procedures for implementing corrective and preventive action; maintaining records related to investigations; validation of computer software used in production or quality systems.