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ARIA To Face FDA In April, OPXA's Woes Continue, Keep An Eye On OPHT

pharma 110116

ARIAD Pharmaceuticals Inc.'s (ARIA) New Drug Application for Brigatinib, proposed for the treatment of patients with metastatic ALK-positive non-small cell lung cancer who were previously treated with Pfizer's (PFE) anti-cancer drug Xalkori, has been accepted for Priority Review by the FDA.

The regulatory agency's decision is set for April 29, 2017.

ARIA closed Monday's trading at $8.72, down 0.68%.

ACADIA Pharmaceuticals Inc. (ACAD) has initiated a phase II study with Pimavanserin for the treatment of agitation in patients with Alzheimer's disease.

The study, dubbed SERENE, is designed to enroll about 430 patients with Alzheimer's disease who have agitation and/or aggression symptoms who will be randomized to receive once daily oral doses of 34 mg Pimavanserin, 20 mg Pimavanserin or placebo for 12 weeks.

ACAD closed Monday's trading at $23.31, up 3.28%.

Gene editing company Cellectis (CLLS) along with its agricultural biotech subsidiary, Calyxt, hosted the world's first dinner made with gene edited foods on October 20, 2016 in New York.

According to the company, the six-course dinner featured Tofu and soy burgers, Hummus soy, gilt-headbream, lemon, Oven-baked potato pie or Soy with marinated fish and caviar, among other dishes.

The dinner, dubbed a meal of the 21st century, was attended by university professors, doctors, reporters, celebrities, entrepreneurs and key opinion leaders.

Commenting on the event, André Choulika, Cellectis CEO and Calyxt president said, "It not only represents a historic moment for the food, agriculture and biotech industries but also for people all over the world who are in search of an answer to address some of the biggest health issues in today's society. This meal is a clear indicator of how gene editing will ultimately transform what we put on our plates in the near future. This was the first harvest dinner, and millions of people will be able to experience these same foods in the near future."

CLLS closed Monday's trading at $17.68, down 1.50%.

Cellectar Biosciences Inc. (CLRB) now expects to initiate a phase II study of CLR 131 in multiple myeloma and other hematologic malignancies during the first quarter of 2017 compared to previous guidance for study initiation in the first half of 2017.

The primary endpoint for the study is Objective Response Rate. Secondary endpoints include Progression-Free Survival and other measures of efficacy. The company anticipates initial efficacy data as early as the second half of 2017.

CLRB closed Monday's trading 5.31% higher at $1.83.

FibroGen Inc. (FGEN) has completed enrollment in its phase III clinical trials in China for Rroxadustat in chronic kidney disease patients suffering from anemia. The trial involves both chronic kidney disease patients on dialysis and chronic kidney disease patients not on dialysis.

The company expects topline data from the trials by early 2017.

FGEN closed Monday's trading at $16.55, down 0.90%.

As previously reported, Ophthotech Corp. (OPHT) expects to report topline data from its two phase III clinical trials of Fovista in combination with Genentech's Lucentis for the treatment of wet age-related macular degeneration in the fourth quarter of this year.

The company announced that its phase 2b study results of Fovista were published in the Journal of the American Academy of Ophthalmology.

In the phase 2b clinical trial, patients receiving the combination of Fovista and Lucentis gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy. This represents a 62% additional benefit from baseline, according to the company.

OPHT closed Monday's trading at $35.82, up 10.39%.

Shares of Opexa Therapeutics Inc. (OPXA), which took a beating on Abili-T trial results last week, slumped further on Monday - touching a new 52-week low.

On October 28, 2016, the company had announced that its phase 2b trial of Tcelna in patients with secondary progressive multiple sclerosis, dubbed Abili-T, did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression.

OPXA touched a new 52-week low of $0.75 on Monday, before closing the day's trading at $0.85, down 19.05%.

The clinical trial results can make or break a drug company. Click here for some of the biotech stocks, which are slated to report clinical trial results in the coming months.

Signal Genetics Inc. (SGNL) and privately-held Miragen Therapeutics Inc. have agreed to merge, following which the combined company will take on the name of Miragen Therapeutics Inc., and change the ticker symbol on the NASDAQ Capital Market to "MGEN."

A 1-for-15 reverse stock split of its common stock will become effective immediately following the close of trading on the NASDAQ Capital Market on November 4, 2016.

The proposed merger has to be approved by stockholders of Signal and Miragen.

SGNL closed Monday's trading at $0.35, up 7.83%.

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