ARDX To Meet With FDA, VRTX Gains In After-Hours, Watch Out For AQXP

(RTTNews) - Aquinox Pharmaceuticals Inc. (AQXP) expects top-line results from a phase II clinical trial of AQX-1125 in female patients with bladder pain syndrome/interstitial cystitis, dubbed LEADERSHIP, near mid-year 2015.

Another phase II clinical trial of AQX-1125, dubbed FLAGSHIP, is underway in patients with chronic obstructive pulmonary disease exacerbations. Top-line results from this study are also expected near mid-year 2015.

AQX-1125 is also being explored in the indication of atopic dermatitis. A phase II clinical trial of AQX-1125 in atopic dermatitis, known as KINSHIP, completed enrollment last month, and top-line results are expected by the first quarter of 2016.

AQXP closed Tuesday's trading at $7.78, up 4.41%.

Ardelyx Inc. (ARDX) is scheduled to have an End of phase 2 meeting with the FDA in order to obtain agreement on pivotal study designs, and safety and efficacy endpoints for phase III studies for Tenapanor to treat constipation-predominant irritable bowel syndrome in June of this year.

Hopefully, the company intends to initiate a phase III clinical program for Tenapanor in IBS-C in the fourth quarter of 2015 and to continue the development of Tenapanor for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis should it regain the worldwide rights to the program.

ARDX closed Tuesday's trading at $9.06, up 0.67%.

Dermira Inc. (DERM) is on track to initiate a phase III program for its topical anticholinergic product candidate, DRM04, in hyperhidrosis in the second half of 2015.

A phase III program of its advanced drug candidate CIMZIA, in adult patients with moderate-to-severe chronic plaque psoriasis, consisting of 3 trials - CIMPASI-1, CIMPASI-2 and CIMPACT, is underway, and all the three trials are now enrolling patients.

The company expects topline results from the phase 3 program of CIMZIA in 2017.

DERM closed Tuesday's trading at $14.99, unchanged from the previous day's close.

Shares of Fibrocell Science Inc. (FCSC) surged more than 20% in after-hours trading on Tuesday following the award of FDA's rare pediatric disease designation to the company's lead orphan gene-therapy drug candidate, FCX-007, for the treatment of recessive dystrophic epidermolysis bullosa.

FCX-007 is currently in late stage preclinical development with an IND filing targeted for mid-2015.

FCSC closed Tuesday's trading 0.85% higher at $3.56. In after-hours, the stock was up another 20.79% to $4.30.

Recro Pharma Inc. (REPH) expects top-line data from a phase II trial of Dex-IN in patients following bunionectomy surgery to be available by mid-year 2015.

Last month, the company completed acquisition of assets from Alkermes plc (ALKS) including worldwide rights to IV/IM Meloxicam, a proprietary, phase III-ready, long-acting COX-2 NSAID for moderate to severe acute pain, as well as a contract manufacturing facility, royalty and formulation business in Gainesville, Georgia.

The acquisition is considered transformative for Recro Pharma, as it brought together two complementary therapies for treating moderate to severe acute pain, IV Meloxicam and Dex-IN.

REPH closed Tuesday's trading at $9.55, down 1.34%.

Shares of Vertex Pharmaceuticals Inc. (VRTX) were up more than 7% in after-hours trading on Tuesday after an FDA panel voted 12 to 1 to recommend approval of the company's cystic fibrosis drug Orkambi.

The company is seeking approval of Orkambi for use in people with cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation in the CFTR gene. The FDA's final decision is set for July 5, 2015. The regulatory agency usually follows the recommendations of its advisory panels, although it is not required to do so.

Orkambi is a combination of an approved drug Kalydeco and investigational compound Lumacaftor. Kalydeco is also from the stable of Vertex Pharma.