ACUR Crushed, RGDX Loosens Purse Strings, QRxPharma's Trading Halted

(RTTNews) - Acura Pharmaceuticals Inc. (ACUR) is down more than 22 percent to $1.44 in pre-market trading on Tuesday as its phase II study assessing the abuse potential of hydrocodone bitartrate with acetaminophen tablet formulated with its abuse deterrent AVERSION technology in recreational drug abusers failed to reach statistical significance in the primary endpoint relating to maximum drug liking.

In the phase II trial, dubbed Study AP-ADF-301, hydrocodone bitartrate and acetaminophen formulated with abuse deterrent AVERSION technology was compared to an equivalent dose of a generic hydrocodone/acetaminophen tablet currently on the market.

The company intends to further evaluate data from Study AP-ADF-301 and plans to meet with the FDA to discuss the results.

Sangamo BioSciences Inc. (SGMO) is all set to acquire Ceregene Inc., a privately held biotechnology company focused on developing adeno-associated virus gene therapies. The acquisition is expected to close in September 2013, subject to customary closing conditions.

SGMO closed Monday's trading at $10.35, up 3.60%. In pre-market trading Tuesday, the stock is up 1.45% to $10.50.

Rigel Pharmaceuticals Inc. (RIGL) dropped 13.50 percent to $3.14 on Monday as its phase II trial of investigational drug R343 in patients with allergic asthma did not meet the primary or secondary endpoints. The company has decided to pull the plug on R343 in the indication of asthma.

Response Genetics Inc. (RGDX) rose more than 27 percent to close Monday's trading at $2.39 following news of the company's acquisition of all of the key assets of privately-held Pathwork Diagnostics, including its FDA-cleared, Medicare-reimbursed test for the diagnosis of metastatic, poorly differentiated and undifferentiated cancer.

The terms of the deal require Response Genetics to make cash payment of $200,000 and issue 500,000 shares of its common stock with a lock-up period through June 2014. The deal is expected to be accretive within its first full year of acquisition.

QRxPharma Ltd. (QRXPY) (QRX.AX) has been placed in trading halt session state in the Australian Securities Exchange until Aug.29 pending the release of an announcement by the company.

The company is in the midst of preparations to submit a revised NDA for MOXDUO IR for the treatment of moderate to severe acute pain.

MoxDuo IR is an immediate-release Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.

This is the company's second attempt at seeking FDA approval for MOXDUO IR's. The company was issued a complete response letter for Moxduo IR NDA last June and was asked to submit additional information with regard to the safety and effectiveness of Moxduo IR.

QRxPharma resubmitted the MOXDUO IR including respiratory safety results of Study 022 in February of this year. The resubmitted MOXDUO IR was scheduled to be reviewed by an FDA panel on July 17, and the regulatory decision date was originally set for August 26, 2013. However, on June 26, the company announced that the planned FDA panel review and the FDA decision date will be delayed as it had to make a data amendment for Study 022.