UTHR, FLML Get Review Date, RTIX Facility Passes FDA Inspection, VTUS On Watch

(RTTNews) - Axxess Pharma Inc. (AXXE), which trades on pink sheets, is working its way to get listed on the Over-the-Counter Bulletin Board Stock Exchange. According to the company, the process is expected to be completed by Q1 2014.

Based on its current growth rate, the company is also targeting an additional move to the NASDAQ in the second quarter of 2015.

AXXE.PK closed Wednesday's trading 1.89% higher at $0.54.

Flamel Technologies S.A.'s (FLML) second new drug application has been accepted for review by FDA - with a decision date set for April 28, 2014. The company noted that it is not disclosing the product's name or the proposed indication at this time due to competitive reasons, but will provide additional information at a later date.

FLML closed Wednesday's trading down 2.46% at $6.34.

Gilead Sciences Inc. (GILD) has filed with the FDA a New Drug Application for Idelalisib for the treatment of indolent non-Hodgkin's lymphoma, or iNHL. If approved, Idelalisib would be the first PI3K delta targeted therapy for a hematological cancer and the first new class of therapy for iNHL in more than a decade.

GILD closed Wednesday's trading 0.11% higher at $62.93.

RTI Surgical Inc. (RTIX) rose nearly 12 percent on Wednesday to close at $3.93 after the FDA inspectors expressed satisfaction with the company's implementation of a series of voluntary corrective actions to improve the overall environmental monitoring within its Alachua, Fla. processing facility.

Last October, the company received a warning letter from the FDA related to environmental monitoring activities in certain areas of its Florida facility. Syneron Medical Ltd. (ELOS) has received FDA clearance and CE mark approval for VelaShape III, the company's new non-invasive body shaping platform.

According to the company, the new platform is effective for temporary reduction in circumference of the abdomen and is also used in a wide range of other body shaping applications such as cellulite treatments.

ELOS lost 0.12% on Wednesday to close at $8.20.

United Therapeutics Corp.'s (UTHR) resubmitted new drug application for treprostinil diolamine extended release tablets for the treatment of pulmonary arterial hypertension has been accepted for review by FDA.

The resubmission, classified as a complete, class 2 response to its March 22, 2013 complete response letter, has a decision date set for February 16, 2014.

UTHR set a new 52-week high of $78.38 on Wednesday before closing at $77.35.

Ventrus Biosciences Inc. (VTUS) expects results from its second pivotal phase III trial of VEN 307 in anal fissures in Q1, 2014. The first pivotal phase III study of VEN 307 for the treatment of anal fissures was successfully completed in 2012.

Assuming a successful outcome in the second phase III study, Ventrus expects to file an NDA for VEN 307 in the second quarter of 2014.

VTUS rose 15.12% on Wednesday to close at $2.97. In after-hours, the stock gained another 3.03% to $3.06.