EVOK Runs Out Of Gas, ELOS Gets FDA Nod, 1 Down, 1 To Go For CYNA, BCLI Abuzz

(RTTNews) - BrainStorm Cell Therapeutics Inc.'s (BCLI) phase II study of NurOwn in patients with Amyotrophic Lateral Sclerosis has achieved its primary objective of safety and tolerability.

NurOwn also achieved multiple secondary efficacy endpoints, including the ALS Functional Rating Scale (ALSFRS), slow vital capacity (SVC) and grip strength, showing clear evidence of a clinically meaningful benefit. Notably, response rates were higher for NurOwn-treated subjects compared to placebo at all time points in the study out to 24 weeks, added the company.

Commenting on the results, Anthony Windebank, Professor of Neurology and Director for Discovery, Mayo Clinic Center for Regenerative Medicine said, "After almost thirty years of conducting clinical studies in ALS I am personally very encouraged and excited by the trial results. There are positive efficacy signals with clear indications to proceed to the next phase. We at Mayo clinic will be eager to move ahead with that as soon as possible."

BCLI closed Monday's trading at $2.71, down 9.36%.

Bristol-Myers Squibb Co.'s (BMY) supplemental Biologics License Application for Opdivo for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck has been accepted for review by the FDA, and the decision date has been set for November 11, 2016.

The company's European marketing application to expand the use of Opdivo for the same indication has also been validated by the European Medicines Agency.

Opdivo is already approved for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma and classical Hodgkin lymphoma.

The drug generated sales of $942 million in 2015 and $704 million in the first quarter of 2016.

BMY closed Monday's trading at $75.96, down 0.05%.

Citius Pharmaceuticals Inc. (CTXR.OB) is expected to start phase III trials for Mino-Lok, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections, early in the first quarter of 2017.

The phase III trials are expected to be completed within two years after the program starts.

CTXR.OB closed Monday's trading at $1.08, up 8.00%.

Cynapsus Therapeutics Inc. (CYNA) (CTH.TO), on Monday, announced positive open-label dose titration phase results from the ongoing CTH-300 trial, which is a pivotal phase III efficacy and safety study evaluating APL-130277 for the treatment of OFF episodes in patients with Parkinson's disease.

The company expects top-line data from the CTH-300 trial to be released near the end of the third quarter or early fourth quarter of this year.

CYNA closed Monday's trading at $16.07, down 0.06%. In after hours, the stock was up 4.48% to $16.79.

Shares of Evoke Pharma Inc. (EVOK) plunged over 73% on Monday, following the failure of its phase III clinical trial of EVK-001 in female patients with symptomatic diabetic gastroparesis.

EVK-001 is an intranasal formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women with diabetes mellitus. Metoclopramide in oral and intravenous formulations is already approved in the United States to treat gastroparesis.

Gastroparesis, a condition in which the stomach takes too long to empty its contents to small intestine, is common in people with diabetes. An estimated 4% to 6% of the people in the U.S. have gastroparesis, according to the American Motility Society Task Force on Gastroparesis. About 80% of the patients affected are women. Nausea, vomiting, abdominal pain, early satiety, and bloating are some of the characteristic symptoms of gastroparesis.

Given that metoclopramide has been approved and used for treating diabetic gastroparesis for more than 35 years, the topline results of the phase 3 clinical trial of EVK-001 are unexpected and an anomaly, noted the company.

EVOK closed Monday's trading at $2.89, down 73.07%.

The marketing authorization application for Telotristat Etiprate for the treatment of carcinoid syndrome, submitted by Ipsen S.A., has been accepted by the European Medicines Agency.

Lexicon Pharmaceuticals Inc. (LXRX) retains rights to market Telotristat etiprate in the U.S. and Japan, while Ipsen has the rights to commercialize it in Europe and other countries outside the U.S. and Japan.

The NDA for Telotristat Etiprate filed by Lexicon is under FDA review, with a decision date set for November 30, 2016.

LXRX closed Monday's trading at $15.06, up 0.53%.

MabVax Therapeutics Holdings Inc. (MBVX.OB) has initiated patient enrollment at Memorial Sloan Kettering Cancer Center in a phase I clinical trial evaluating its new generation diagnostic PET imaging agent, MVT-2163 for patients with locally advanced or metastatic adenocarcinoma of the pancreas or other CA19-9 positive malignancies. The interim results from this trial are expected during the third quarter of 2016.

Another phase I trial evaluating MVT-5873 in patients with metastatic pancreatic cancer is also underway - with results expected this quarter.

MBVX.OB closed Monday's trading at $0.52, unchanged from the previous day's close.

Syneron Medical Ltd. (ELOS) has received FDA clearance for its UltraShape Power for non-invasive reduction of abdominal circumference via fat cell destruction.

In a clinical study, UltraShape Power has demonstrated a 32% reduction in abdominal fat layer thickness.

The device has been available outside of the U.S. since the second quarter 2016. In the U.S., it is expected to be launched this quarter.

ELOS closed Monday's trading at $7.31, down 1.62%.