EXAS Gets FDA Panel's Thumbs Up, NRX Ropes In Partners, PRPH Breathes Easy

(RTTNews) - Exact Sciences Corp.'s (EXAS) Cologuard, the first of its kind stool-based DNA screening test for colorectal cancer, has been unanimously recommended for approval by an FDA panel.

The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Cologuard PMA.

EXAS closed Thursday's trading at $13.75. The stock was up 6.91% to $14.70 in after-hours.

NephroGenex Inc. (NRX) has partnered with Collaborative Study Group, a nephrology academic research organization, and Medpace, a contract research organization, to conduct phase III studies evaluating its experimental drug Pyridorin in diabetic nephropathy.

The company expects to launch the first of two phase III trials in the first half of 2014.

NephroGenex went public on the NASDAQ Capital Market under the ticker symbol "NRX" as recently as February 11, 2014, pricing its shares at $12 each.

NRX closed Thursday's trading 4.40% higher at $7.83.

Portola Pharmaceuticals (PTLA) has initiated a phase II proof-of-concept study to evaluate Andexanet alfa, its investigational antidote, to reverse the anticoagulation activity of Daiichi Sankyo's oral, once-daily, direct Factor Xa inhibitor Edoxaban in healthy volunteers.

In the study, healthy volunteers will be treated on days 1-6 with Edoxaban 60 mg once a day and then randomized in a 6:3 ratio to intravenous Andexanet alfa or placebo on day 6. The first dose cohort will evaluate a 600 mg bolus dose of Andexanet alfa or placebo in 9 healthy volunteers. Pharmacodynamic and safety data will be collected through day 48.

The study is funded by Daiichi Sankyo while full worldwide commercial rights to Andexanet alfa are retained by Portola.

Shares of ProPhase Labs Inc. (PRPH), which markets Cold-EEZE Cold Remedy brand as well as other cold relief products, rose more than 5% to $2 on Thursday, following the company's financial report for fiscal 2013, which represents its first profitable fiscal year since 2005.

The company generated net income for the year ended December 31, 2013, of $405 thousand or $0.03 per share on net sales of $25.0 million. This compares with a net loss of $1.1 million or $0.07 per share and net sales of $22.4 million in 2012.

pSivida Corp.'s (PSDV) licensing partner Alimera Sciences Inc. (ALIM) has resubmitted the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema to FDA.

The U.S. regulatory agency issued a complete response letter to ILUVIEN last October, citing concerns regarding the benefit to risk and safety profiles. The FDA had also indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients.

In the resubmitted NDA, Alimera has responded to questions raised in the FDA's October 2013 complete response letter and has provided a safety update, which includes commercial experience with ILUVIEN in Europe.

ILUVIEN has received marketing authorizations in Austria, the United Kingdom, Portugal, France, Germany and Spain and is commercially available in the United Kingdom and Germany.

ALIM closed Thursday's trading 1.43% higher at $7.08.

Quidel Corp. (QDEL) has received FDA clearance for the sale of its AmpliVue HSV 1+2 Assay for the differentiation and detection of herpes simplex viruses 1 and 2. It is estimated that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection.

QDEL closed Thursday's trading at $27.87, down 0.46%.