ARGS On The Rise, ATOS Slides After FDA Seeks More Data, XOMA Quits EOA Trial

By RTT News, March 05, 2014, 12:08:00 AM EDT

(RTTNews.com) - Argos Therapeutics Inc. ( ARGS ) touched a new high of $12.55 on Tuesday before closing at $12.30 following new positive findings from a completed phase IIa clinical trial of AGS-004 for the treatment of HIV infection.

AGS-004 has been found to induce anti-HIV T memory stem cell-like immune responses in chronic HIV patients and these responses are associated with viral load control in the absence of ART (Antiretroviral Therapy) drugs, said the company.

According to the company website, in an ongoing phase IIb clinical trial of AGS-004 enrollment is complete, and results are expected in the second quarter of 2014.

Atossa Genetics Inc. ( ATOS ) dropped 11.32% to $1.88 following FDA's request for additional information related to 510(k) application for ForeCYTE Breast Aspirator.

The company submitted a Premarket 510(k) Notification with the FDA seeking clearance of the ForeCYTE Breast Aspirator, including the ForeCYTE breast pump and patient collection kit, which are intended for use in the collection of nipple aspirate fluid for laboratory cytological testing last December.

Now that the regulatory agency has asked for additional information, Atossa plans to request an extension to the 30 day time limit by which a response must be provided to the FDA. If the request for an extension is granted, Atossa will have up to 180 days to provide a response to the FDA's questions.

Cellectar Biosciences Inc. (CLRB.OB) has initiated a phase II imaging trial of I-124-CLR1404 in patients with glioblastoma. This trial is designed to enroll 36 patients, and results are expected by year-end 2014.

CLRB.OB closed Tuesday's trading 7.69% higher at $0.42.

Eleven Biotherapeutics ( EBIO ) expects top line data from a phase II study of EBI-005 for the treatment of allergic conjunctivitis to be available in the second half of 2014. The company expects top-line data from the first pivotal phase III trial of EBI-005 for the treatment of moderate to severe dry eye disease to be released in early 2015.

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ARGS On The Rise, ATOS Slides After FDA Seeks More Data, XOMA Quits EOA Trial