BDSI On Watch, Busy Months Ahead For LJPC, AQXP Awaits Leadership

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) has initiated a pivotal phase 3 study of ARX-04, a non-invasive, single-use 30 mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator, for the treatment of moderate-to-severe acute pain.

The company anticipates enrollment to take up to nine months, and top-line results from the study are expected in the fourth quarter of 2015.

ACRX closed Monday's trading at $3.92, down 3.33%.

Shares of Advaxis Inc. (ADXS) touched a new high after the company reported encouraging preliminary data from a phase 1/2 trial of its lead immunotherapy product candidate ADXS-HPV in HPV-associated anal cancer in combination with chemoradiation.

According to the trial results, all patients who have completed treatment in the study have had a complete response with no evidence of recurrence to date. ADXS-HPV was well tolerated by the treated patients, and all treatment-related toxicities were within 24 hours of dosing, the most frequent of which include chills/rigors, fever and nausea.

ADXS touched a new high of $14.50 on Monday before closing the day's trading at $13.01.

ARCA biopharma Inc. (ABIO) expects its phase 2b/3 clinical trial evaluating Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation to be completed by year-end 2016.

The trial, dubbed GENETIC-AF compares the safety and efficacy of Gencaro to approved heart drug Toprol-XL (metoprolol succinate) for the treatment of atrial fibrillation in patients with heart failure and left ventricular systolic dysfunction (HFREF patients).

The phase 2b portion of the trial is seeking to enroll approximately 200 patients and the phase 3 portion seeks to enroll an additional 420 patients.

ABIO closed Monday's trading at $0.81, down 1.22%. In after-hours the stock was down 4.94% at $0.77.

Aquinox Pharmaceuticals Inc. (AQXP) is a stock to keep on your radar as the upcoming milestones can have a significant effect on its price.

The company has completed enrollment of patients in FLAGSHIP, a phase 2 clinical trial of AQX-1125 in chronic obstructive pulmonary disease exacerbations, and expects top line results near mid-year 2015.

Another phase 2 clinical trial, dubbed LEADERSHIP, evaluating AQX-1125 in bladder pain syndrome/interstitial cystitis, has achieved target enrollment, and top line results are expected near mid-year 2015.

The company is also conducting a phase 2 clinical trial of AQX-1125 in atopic dermatitis - with top line results expected by the first quarter 2016.

AQXP closed Monday's trading at $11.50, down 4.80%.

BioDelivery Sciences International, Inc. (BDSI) expects results of its first phase 3 study for Clonidine Topical Gel for treatment of painful diabetic neuropathy to be available by the end of this month. A second phase 3 trial for Clonidine Topical Gel is anticipated to be initiated around the same time.

The company's New Drug Application for BELBUCA for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, is under FDA review, with a decision scheduled for October 23, 2015.

BDSI closed Monday's trading at $14.60, down 1.15%. In after hours, the stock was down 2.74% to $14.20.

Shares of Immune Pharmaceuticals Inc. (IMNP) were up more than 8% in extended trading on Monday after the company announced that it has entered into a binding memorandum of understanding with Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem, to develop novel topical nanoparticle formulation of its neuropathic pain drug AmiKet.

AmiKet is ready for phase III clinical trial in post herpetic neuralgia and has been granted Orphan Drug Designation by the FDA.

Immune Pharmaceuticals, which is currently scouting for a partner for the final development and commercialization of AmiKet, expects to select a partner and secure a licensing agreement by the second quarter of 2015.

IMNP closed Monday's trading 0.56% higher at $1.78. In after-hours, the stock was up 8.99% to $1.94.

La Jolla Pharmaceutical Co. (LJPC) has a couple of clinical trial events lined up for the coming months.

In the first quarter of 2015, La Jolla plans to initiate a phase 3 trial of LJPC-501 in catecholamine-resistant hypotension, and a phase 2b trial of GCS-100 in diabetic patients with Stage 3b or 4 chronic kidney disease.

In the second quarter of 2015, La Jolla plans to file an Investigational New Drug Application with the FDA and initiate a phase 1 clinical trial of LJPC-1010, its second-generation galectin-3 inhibitor.

The company plans to file an IND with the FDA and initiate a phase 1 clinical trial of LJPC-401, its novel formulation of hepcidin, in the second half of 2015.

LJPC closed Monday's trading at $21.37, down 7.89%.

Synergy Pharmaceuticals Inc. (SGYP) is slated to report top-line results from a pivotal phase 3 trial evaluating the safety and efficacy of Plecanatide of 3.0 mg dose in patients with chronic idiopathic constipation in the second quarter of 2015. The top-line results from another phase 3 trial evaluating Plecanatide of 6.0 mg dose in patients with chronic idiopathic constipation are anticipated in the third quarter of 2015.

The company plans to file its first new drug application with the FDA for Plecanatide to treat chronic idiopathic constipation in the fourth quarter of this year.

SGYP closed Monday's trading at $3.71, up 4.51%.

Vascular Solutions Inc. (VASC) has commenced sales of PolarCath peripheral dilatation system in the United States in collaboration with NuCryo Vascular LLC, the manufacturer of the product.

The PolarCath peripheral dilatation system is indicated for use in dilating stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath system is also indicated for post-deployment stent expansion of self-expanding peripheral vascular stents.

Vascular Solutions is the exclusive U.S. distributor of the PolarCath product line as per the terms of an agreement entered into with NuCryo in November of 2014.

The company is projecting between $3 million to $5 million in PolarCath sales during 2015.

VASC closed Monday's trading at $28.87, down 0.31%.