PTIE Working On Remoxy, CPRX Awaits Catalysts, There's Reason To Watch MCUR

(RTTNews) - Acasti Pharma Inc. (ACST) has now been given an additional 180 calendar days, until November 2, 2015, to regain compliance with the minimum $1.00 per share requirement for continued listing on the NASDAQ.

The company was notified by the NASDAQ on November 7, 2014 for not maintaining a minimum bid price of US$1.00 per share for 30 consecutive business days and was then given time until May 6, 2015, to regain compliance.

ACST closed Monday's trading at $0.39, down 4.67%.

Anthera Pharmaceuticals Inc. (ANTH) expects full enrollment of 400 patients in its phase III study of Blisibimod for the treatment of systemic lupus erythematosus to be completed this year - with top-line efficacy data expected in the second half of 2016.

ANTH closed Monday's trading at $4.48, up 0.67%.

Catalyst Pharmaceutical Partners Inc. (CPRX) has a couple of events lined up for the coming months.

The company is all set to initiate submission of rolling NDA for Firdapse for the treatment of Lambert-Eaton myasthenic syndrome, or LEMS in the third quarter, with anticipated completion of submission during the fourth quarter of this year.

A phase 1(b) multiple dose safety and tolerance study for CPP-115 is underway, and topline results are expected in Q3, 2015.

CPP-115 has the potential to treat infantile spasms, and epilepsy, as well as other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette Syndrome, according to the company.

Another drug candidate of Catalyst Pharma is CPP-109, and top-line results from Mt. Sinai academic investigator sponsored study evaluating CPP-109 as a surrogate for CPP-115, for the treatment of Tourette's disorder are expected during this quarter.

CPRX closed Monday's trading at $3.41, down 0.29%.

Idera Pharmaceuticals Inc. (IDRA) expects efficacy and safety data from its phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia, a form of non-Hodgkin lymphoma, in the fourth quarter of 2015.

Another phase 1/2 clinical trial of IMO-8400 in diffuse large B-cell lymphoma is underway, with efficacy and safety data from this trial anticipated in 2016.

IDRA closed Monday's trading 10.11% higher at $3.05.

Macrocure Ltd. (MCUR) expects futility analysis results for its phase III study of its lead product CureXcell in Venous Leg Ulcers to be available by August 2015. The full results from this study are expected in the first half of 2016.

A phase III clinical trial of CureXcell in Diabetic Foot Ulcers is also underway, and results from this study are anticipated in October 2015.

MCUR closed Monday's trading at $9.79, up 0.62%.

NewLink Genetics Corp.'s (NLNK) phase III pancreatic cancer trial with its investigational drug Algenpantucel-L is set to continue without any modification or sample size adjustment.

The trial, dubbed IMPRESS, which has enrolled 722 patients, is evaluating standard adjuvant therapy alone or in combination with Algenpantucel-L in patients who have undergone surgical resection for pancreatic cancer.

NLNK closed Monday's trading at $52.14, up 0.89%. In after hours, the stock fell 18.68% to $42.40.

Pain Therapeutics Inc. (PTIE) plans to refile the NDA for REMOXY with FDA in the first quarter of 2016. REMOXY is an investigational extended-release oral formulation of oxycodone for patients with moderate-to-severe chronic pain.

REMOXY has been at the FDA altar twice, and it was issued a complete response letter on both the occasions - in December 2008 and in June 2011.

PTIE closed Monday's trading at $1.94, down 1.52%.

Synergy Pharmaceuticals Inc. (SGYP) expects top-line data from its first phase III trial of Plecanatide for chronic idiopathic constipation in the second quarter of 2015, and top line data from the second phase III trial of Plecanatide for chronic idiopathic constipation in the third quarter of this year.

If all goes well as planned, the NDA for Plecanatide in the CIC indication may be filed with the FDA in December 2015.

A phase III trial of Plecanatide irritable bowel syndrome with constipation (IBS-C) is underway, and the company plans to initiate the second phase III IBS-C trial in the first half of this year.

The company plans to announce top-line data results from the first phase III IBS-C trial in 4Q 2015 and the second phase III IBS-C trial is expected to readout in the first half of 2016. Synergy plans to file an NDA with Plecanatide in the IBS-C indication in the second half of 2016.

SGYP closed Monday's trading at $3.61, up 0.28%.

ZS Pharma Inc. (ZSPH) is scheduled to file a New Drug Application for its lead therapeutic candidate ZS-9 with the FDA this quarter, and a Marketing Authorization Application for ZS-9 with the European Medicines Agency in the second half of 2015.

ZS-9 (sodium zirconium cyclosilicate) is an investigational treatment for hyperkalemia.

ZSPH closed Monday's trading at $49.44, up 1.42%.