ADMP Awaits Decision, REGN Can Catch Your Eye, SQNM Does A Deal, ZLTQ Goes Cool

(RTTNews) - Adamis Pharmaceuticals Corp.'s (ADMP) New Drug Application for EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) for the emergency treatment of allergic reactions (Type I) including anaphylaxis has been accepted for review by the FDA.

The regulatory decision for marketing authorization for the PFS in the U.S. is expected in the first half of 2015. If approved, Epinephrine Pre-Filled Syringe will be the company's first product to generate revenues.

ADMP closed Tuesday's trading at $3.88, down 1.27%.

Fate Therapeutics Inc. (FATE) is all set to begin a phase 1b study of PROHEMA in pediatric patients undergoing hematopoietic stem cell (HSC) transplantation for the treatment of inherited metabolic disorders, or IMDs, in the fourth quarter of 2014.

According to the company, the study, dubbed PROVIDE, will enroll up to 12 patients with various forms of IMDs, between the ages of 1 and 18, at up to three leading U.S. pediatric HSC transplant centers.

FATE closed Tuesday's trading at $6.12, down 2.08%.

Neurotrope Inc. (NTRP.OB) has initiated a phase 2a clinical trial of its drug candidate Bryostatin for the treatment of patients with Alzheimer's disease. The top-line analysis of this study is expected to be reported by the end of the first quarter of 2015.

NTRP.OB closed Tuesday's trading at $1.00, up 8.70%.

The FDA has approved the expanded use of Regeneron Pharmaceuticals Inc.'s (REGN) EYLEA to treat Diabetic Macular Edema, which marks the third approved indication for the product in the U.S.

EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration in 2011, and for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO.

In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME.

REGN closed Tuesday's trading at $304.51, up 0.78%.

Sequenom Inc. (SQNM) has inked a license agreement with Mayo Medical Laboratories for noninvasive prenatal testing patents and applications. The terms of the agreement are not disclosed.

SQNM closed Tuesday's trading at $3.72, down 1.33%.

ZELTIQ Aesthetics Inc. (ZLTQ) has upped its full-year 2014 revenue outlook, following better-than-expected Q2 results, thanks to the growing momentum and awareness for CoolSculpting, the company's non-surgical contouring treatment for fat reduction.

The company moved into the black in Q2 as total revenue rose 79 percent from the year-ago quarter. The installed global base of CoolSculpting systems at June 30, 2014 is 2,562 compared to 2,175 at March 31, 2014.

Looking ahead, ZELTIQ has raised its 2014 revenue outlook to a range of $160 million to 165 million, up from a prior estimate of $137 million to $140 million. The revised revenue estimate for 2014 represents a 43% to 48% year-over-year growth.

ZLTQ closed Tuesday's trading at $16.59. In pre-market trading on Wednesday, the stock is up over 26% to $21.