By RTT News, October 06, 2013, 11:51:00 PM EDT
(RTTNews.com) - Atossa Genetics Inc. ( ATOS ) plunged nearly 50 percent to $2.67 in extended trading on Friday, following the voluntary recall of its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. The company noted that nearly ninety percent of these products are in inventory with its distributors and the remaining quantities are at customer sites across the United States.
The voluntary recall has been initiated to address concerns raised by the FDA regarding the current instructions for use; certain promotional claims used to market these devices; and the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU.
Atossa was notified of the concerns by the FDA in February of this year. The products stand removed from the market until FDA's concerns are addressed.
CEL-SCI Corp. ( CVM ) has been granted an extension until October 31, 2013 to regain compliance with the NYSE MKT Exchange's continued listing standards. The company was issued a notice of delisting in July of this year due to sustained substantial losses that jeopardized the company's ability to continue operations or meet maturing obligations.
The company was earlier given time until September 30, 2013 to regain compliance, which has now been extended by 1 month.
CVM closed Friday's trading at $1.21, down 9.02%.
Discovery Laboratories Inc. ( DSCO ) intends to commercially introduce SURFAXIN in the fourth quarter of 2013, now that the FDA has agreed to the company's updated product specifications for SURFAXIN (lucinactant) Intratracheal Suspension.
SURFAXIN was approved by the FDA last March for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
DSCO closed Friday's trading at $2.70, up 37.06%.
MediciNova Inc. ( MNOV ) has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-029 (denibulin) di-hydrochloride. Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2032.
MN-029 is the company's non-core drug candidate for the treatment of solid tumors, which has completed 2 phase I trials.
MNOV closed Friday's trading at $2.52, up 0.80%.
Puma Biotechnology Inc. ( PBYI ) has initiated a phase II clinical trial of its lead drug candidate PB272 (neratinib) as a single agent in patients with solid tumors who have an activating HER2 mutation. The company noted that the initial indication on the efficacy of neratinib will be got by late this year or early next year.
PBYI closed Friday's trading at $56.29, up 1.94%.
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