AQXP Fails To Lead, Concordia To Get Better Visibility, EXAC Gets FDA Nod

(RTTNews) - Aquinox Pharmaceuticals Inc.'s (AQXP) phase II clinical trial investigating the ability of 200mg oral, once daily AQX-1125 to reduce pain in female patients with bladder pain syndrome/interstitial cystitis, or BPS/IC, has not met the statistical endpoint.

The primary endpoint was to measure the difference in the change from baseline in the mean daily bladder pain score based on an 11-point numeric rating scale (NRS) at six weeks recorded by electronic diary.

However, AQX-1125 has demonstrated a reduction in pain for patients on AQX-1125 compared to those patients on placebo following six weeks of treatment in the trial, dubbed LEADERSHIP, the company noted.

According to the trial results, the mean change in pain score for patients on 200mg oral, once daily AQX-1125 vs. placebo was a reduction of 2.4 vs. 1.3 points, respectively. Approximately 49% of patients receiving AQX-1125 demonstrated a 2-point or greater reduction in pain compared to 34% of patients receiving placebo.

The company believes that the top line data supports further development of AQX-1125 for BPS/IC patients.

AQXP closed Thursday's trading at $7.27, down 7.74%.

BioBlast Pharma Ltd.'s (ORPN) drug candidate Cabaletta has received Orphan Drug Designation from the European Commission for the treatment of Oculopharyngeal Muscular Dystrophy.

The company plans to initiate a 12 month, placebo-controlled, multi-center phase III study of Cabaletta in the next quarter that will begin enrolling approximately 60 Oculopharyngeal Muscular Dystrophy patients in the U.S. and Canada into this new trial. This study is expected to be completed by the end of 2016.

BioBlast has received Orphan Drug Designation for Cabaletta in OPMD from the FDA in the U.S.

ORPN closed Thursday's trading at $8.01, down 1.60%.

Concordia Healthcare Corp. (CXR.TO) (CHEHF.OB) will begin trading on the NASDAQ Global Select Market on June 29, 2015 under the symbol CXRX.

The company's common shares will continue to trade on the Toronto Stock Exchange.

Concordia's revenue and net income have increased significantly over the years. Net income, which was $2.43 million or $2.23 per share in 2013, rose to $11.59 million or $1.88 per share in 2014. Similarly, revenue, which was $40.45 million in 2013, jumped to $122.19 million in 2014.

In the first quarter ended March 31, 2015, net income was $5.67 million or $0.53 per share and revenue was $36.44 million. This compares with a net loss of $1.84 million or $0.05 per share and revenue of $16.81 million in the first quarter of 2014.

CXR.TO closed Thursday's trading at C$95, up 2.78%.

Exactech Inc. (EXAC) has received clearance from the FDA to market Optetrak Logic Constrained Condylar Prosthesis for revision knee arthroplasty cases.

The device is indicated for use in patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;, and also when previous devices have failed.

The Optetrak Logic CC system will have limited availability in 2015, ramping up to a full market launch in 2016, according to the company.

When reporting its Q1, 2015 results in April of this year, the company forecast its second quarter revenue range as $61 million to $63 million and diluted EPS range as $0.26 to $0.28 per share.

For the full year 2015, the company expects revenue in the range of $248 million to $254 million and diluted EPS in the range of $1.18 - $1.24 per share.

EXAC closed Thursday's trading at $21.40, up 0.71%.

Immune Pharmaceuticals Inc. (IMNP) has *initiated its phase II clinical trial of Bertilimumab in ulcerative colitis, and is scheduled to initiate its phase II trial of Bertilimumab in Bullous Pemphigoid on July 1, 2015.

The phase II trial of Bertilimumab in ulcerative colitis is designed as a double blind placebo controlled trial in 42 patients, with moderate to severe disease. The completion of the trial is expected by the end of 2016.

The phase II Bullous Pemphigoid clinical trial with Bertilimumab is designed as an open label clinical trial in 10 patients, with moderate to severe Bullous Pemphigoid. (Bullous Pemphigoid is an orphan chronic skin blistering disease affecting around 60,000 people globally, mostly in the elderly population, according to a Chardan Capital report.

Initial data from the Bullous Pemphigoid trial is expected in late 2015 or early 2016.

Note: *Study initiation is the training of hospital staff to allow for patient screening and immediate patient enrollment into the clinical trial upon selection.

IMNP closed Thursday's trading at $1.96, up 1.55%.

ITUS Corp. (ITUS.OB) is implementing a 1 for 25 reverse stock split of its common shares today (June 26, 2015) in order to help the company become eligible for listing on The NASDAQ Stock Market.

In the fiscal year ended October 31, 2014, the company reported revenue of $3.67 million, an 840% increase over fiscal 2013, and a 25% reduction in cash used in operating activities to $2.38 million.

ITUS.OB closed Thursday's trading at $0.14, down 3.48%.

Merrimack Pharmaceuticals Inc.'s (MACK) New Drug Application for MM-398 has been accepted for priority review by the FDA, with a decision scheduled for October 24, 2015.

Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

MM-398 is also under review by the European Medicines Agency.

Baxter has exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan while Merrimack retains commercialization rights in the United States, and PharmaEngine Inc. holds the rights to commercialize MM-398 in Taiwan.

MACK closed Thursday's trading at $12.44, up 4.54%.