ARIA Loses Pace, DVAX On The Move, BDSI, CHTP Get FDA Dates, ACUR Buys Peace

(RTTNews) - Shares of Acura Pharmaceuticals Inc. (ACUR) rose over 28 percent in extended trading on Wednesday to $2.18 following patent settlement agreement, related to its pain drug Oxecta, with Par Pharmaceutical and Impax Laboratories.

Par is the first filer of an ANDA for a generic Oxecta product, and as per the terms of the Settlement Agreement reached now, Par may launch its generic Oxecta product in the U.S., through the grant of a non-exclusive, royalty-bearing license from Acura to Par that would trigger on January 1, 2022.

Alkermes plc (ALKS) is planning to advance ALKS 5461 into phase III development for the treatment of patients with major depressive disorder who have inadequate response to standard therapies in early 2014.

ALKS closed Wednesday's trading at $30.17, down 0.40%.

ARIAD Pharmaceuticals Inc. (ARIA) plunged to a new low of $4 before closing at $5.83 on Wednesday, down over 65 percent from the previous day's close, following safety concerns of its leukemia drug Iclusig.

Iclusig was approved last December under the FDA's accelerated approval program.

After 24 months of follow up of Iclusig-treated patients in a pivotal trial, dubbed PACE, it has been found that serious arterial thrombosis occurred in 11.8% of them, cardiovascular events 6.2%, cerebrovascular events 4.0% and peripheral vascular events 3.6% (some patients had more than one type of event.

The FDA has placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig.

BioDelivery Sciences International Inc.'s (BDSI) New Drug Application for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the FDA. The regulatory agency's decision is expected by early June 2014.

BDSI closed Wednesday's trading at $4.97, down 3.68%.

Chelsea Therapeutics International Ltd.'s (CHTP) New Drug Application seeking approval to market NORTHERA, an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension will be reviewed by an FDA panel tentatively scheduled for January 14, 2014.

The FDA's decision date is set for February 14, 2014.

CHTP closed Wednesday's trading at $2.66, down 1.85%. In after-hours, the stock gained 9.02% to $2.90.

Dynavax Technologies Corp. (DVAX) has initiated phase I study of AZD1419, a candidate drug for asthma, in healthy subjects. About 45 healthy subjects will receive inhaled doses of AZD1419 or placebo in single and multiple ascending doses in the first part of the study, followed by up to approximately 24 patients with mild asthma in the second part of the study.

Safety data from the first part of the study is expected in mid-2014.

DVAX closed Wednesday's trading at $1.13, down 6.61%. In after-hours, the stock gained 3.54% to $1.17.

GeoVax Labs Inc. (GOVX.OB) rose more than 8 percent to $0.40 on Wednesday following news that the company's first generation preventive HIV vaccine, HVTN 205, demonstrated significant durability of the antibody response - with the patient antibody levels declining less than 3-fold at 6 months post-vaccination, in a phase 2a trial.

Immunomedics Inc. (IMMU) has regained worldwide rights to investigational compound Veltuzumab for all non-cancer indications from Takeda Pharmaceutical Co.

Veltuzumab was licensed by Immunomedics to Nycomed for all non-cancer indications worldwide under an agreement signed in 2008. Nycomed was acquired by Takeda Pharmaceutical Company in September, 2011.

Immunomedics is in dispute with Nycomed concerning delays in the development of Veltuzumab.

IMMU closed Wednesday's trading at $5.60, down 5.88%.

Portola Pharmaceuticals Inc. (PTLA) has initiated a phase 1/2 clinical study of PRT2070, which is being developed for patients with genetically-defined hematologic cancers, as well as for patients who have failed therapy due to relapse or acquired mutations.

Initial clinical data for PRT2070 are expected in 2014.

PTLA closed Wednesday's trading down 3.57% at $22.41. In after-hours, the stock was up 0.04% at $22.42.

Australian biotech company QRxPharma Limited (QRXPY.PK) said its meeting on October 3 with the FDA to discuss the company's MOXDUO New Drug Application has been positive.

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

MOXDUO NDA was issued a complete response letter twice - on June 27, 2012 and on August 28, 2013.

The company expects to refile the NDA by mid-November 2013.