ATOS Looks Forward To ForeCYTE, ACT Gets Its Act Wrong, SGYP On Watch

(RTTNews) - Atossa Genetics Inc. (ATOS) has submitted premarket 510(k) notification for its ForeCYTE Breast Aspirator, consisting of a breast pump and patient collection kit, to FDA seeking clearance in the indication of breast cancer detection.

In October, Atossa voluntarily recalled the ForeCYTE Breast Health Test from the market after the FDA raised concerns about the instructions for use of the device and questioned certain promotional claims. The regulatory agency also stressed the need for regulatory approval of certain changes in the nipple aspirate fluid collection process.

The company expects to re-launch its ForeCYTE device upon receiving clearance from the FDA.

ATOS closed Tuesday's trading 11.11% higher at $2.60.

Actavis plc (ACT) has been issued a complete response letter by FDA for its New Drug Application for progestin-only transdermal contraceptive patch to prevent pregnancy in women.

In the complete response, the FDA has raised questions regarding the difference between the transdermal patch used in the clinical trial and the to-be-marketed transdermal patch, which represents a different size/formulation.

ACT closed Tuesday's trading at $164.90, down 0.64%.

Synergy Pharmaceuticals Inc. (SGYP) has closed patient enrollment in its plecanatide phase IIb clinical trial in irritable bowel syndrome with constipation. The company expects reporting topline data from this trial in the beginning of the second quarter of 2014.

SGYP closed Tuesday's trading 3.20% higher at $4.84.