GMED Expands Product Portfolio, CVM On Track, TCON To Get $3 Mln, REPH On Watch

(RTTNews) - CEL-SCI Corp.'s (CVM) ongoing phase III trial of its investigational immunotherapy Multikine in just diagnosed, not yet treated patients with head and neck cancer enrolled 25 patients last month.

The total patient enrollment is now 488 as of June 30, 2015 in the world's largest phase III study in head and neck cancer, according to the company. A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in about 25 countries by the end of March 2016.

CVM closed Wednesday's trading at $0.69, up 4.55%.

Clovis Oncology Inc. (CLVS) has initiated rolling NDA submission to the FDA for Rociletinib in the treatment of advanced EGFR-mutant non-small cell lung cancer. The NDA submission is expected to complete by late July.

Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014.

The Marketing Authorization Application for Rociletinib to the European Medicines Agency is also expected to be completed at the end of July 2015.

CLVS closed Wednesday's trading at $85.88, down 2.28%.

Globus Medical Inc. (GMED) has introduced the latest addition to its portfolio of expandable spacers - RISE-L, an expandable lumbar fusion device.

The RISE Spacer is intended for use in patients with degenerative disc disease at one or two contiguous levels of the lumbosacral spine (L2-S1). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

The company reported record quarterly sales in the first quarter ended March 31, 2015, helped by consistent, steady execution of its growth strategy over the past several quarters, primarily the introduction of innovative products, the expansion of its U.S. and international sales footprint, and disciplined expense control.

Globus Medical expects full year 2015 sales to be approximately $514 million and diluted earnings per share to be approximately $1.02 per share. This compares with full year 2014 sales of $474.4 million and diluted EPS of $0.97.

GMED closed Wednesday's trading at $25.83, up 0.62%.

Recro Pharma Inc. (REPH) has entered into a definitive purchase agreement with institutional investors to issue and sell an aggregate of 1.38 million shares of common stock in a private placement resulting in aggregate gross proceeds of about $16 million.

The purchase price for the common stock will be $11.60 per share. The private placement is expected to close on or about July 7, 2015 and is subject to the satisfaction of customary closing conditions.

The net proceeds of the financing will be used to further fund the clinical development of Recro Pharma's lead candidates, IV/IM meloxicam and Dex-IN, in addition to general corporate purposes.

IV/IM meloxicam is a phase III-ready compound for postoperative pain while Dex-IN is under a phase II trial in patients following bunionectomy surgery, with top-line results scheduled for mid-year 2015.

REPH closed Wednesday's trading at $12.94, up 0.15%.

TRACON Pharmaceuticals (TCON) is all set to receive a $3 million milestone payment from its partner Santen Pharmaceutical Co., following the filing of an Investigational New Drug Application with the FDA for the initiation of clinical studies for DE-122 in patients with wet AMD.

DE-122 is the ophthalmic formulation of TRACON's proprietary anti-endoglin antibody, TRC105. In March 2014, Santen licensed the global rights for the development of TRC105 in ophthalmology from Tracon.

TCON closed Wednesday's trading at $11.69, up 3.18%.