GALE Climbs On IDMC's Guidance, NAVB Seeks Dual Listing, OCAT Gets Funds

(RTTNews) - Acura Pharmaceuticals Inc. (ACUR) is all set to effect a 1-for-5 reverse stock split of its common stock on August 27, 2015, and the common stock will begin trading on a split-adjusted basis the following day.

The reverse stock split, which will allow the company to maintain the listing of its common stock on The NASDAQ Capital Market, will reduce the number of shares currently outstanding from approximately 59 million shares to about 11.80 million shares.

In the second quarter ended June 30, 2015, the company narrowed its loss to $2.7 million or $0.05 per share and improved its revenue significantly to $0.3 million. This compared with a net loss of $3.5 million or $0.07 per share and revenue of $35 thousand in the second quarter of 2014.

ACUR closed Monday's trading at $0.58, down 6.18%.

Exelixis Inc.'s (EXEL) lead compound Cabozantinib as a potential treatment for patients with advanced renal cell carcinoma who have received one prior therapy has been granted Breakthrough Therapy Designation by the FDA.

The company expects to complete the Cabozantinib NDA submission in advanced renal cell carcinoma prior to the end of 2015.

Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC.

The net product revenue from COMETRIQ sales was $8.0 million for the second quarter of 2015 compared to $6.56 million in the year-ago quarter.

EXEL closed Monday's trading at $5.08, down 3.24%.

The FDA has expanded the approved use of Promacta, co-discovered by GlaxoSmithKline plc (GSK) and Ligand Pharmaceuticals Inc. (LGND) for children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets.

Promacta in tablet formulation was approved by the FDA in 2008 for use in adult patients and in June of 2015, was expanded to include children 6 years of age and older.

Promacta was acquired by Novartis in March 2015 from GlaxoSmithKline. Promacta had sales of $116 million in Q2, 2015 compared to $99 million in the first quarter of this year, and Ligand Pharma expects Promacta sales to be about half a billion dollars in the full year of 2015.

LGND closed Monday's trading at $83.18, down 1.68%.

Shares of Galena Biopharma Inc. (GALE) climbed more than 11% on Monday, following the Independent Data Monitoring Committee's recommendation to reduce the cardiac toxicity monitoring for patients in the company's phase III trial of NeuVax for breast cancer.

The trial, dubbed PRESENT, is being conducted under the FDA's Special Protocol Assessment, and has enrolled a total of 758 patients.

The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events (recurrence or death) occur, whichever comes later, according to the company.

GALE closed Monday's trading 11.94% higher at $1.50.

Navidea Biopharmaceuticals Inc. (NAVB) has filed an application for registration of shares of its common stock for dual listing on the Tel-Aviv Stock Exchange.

The company's marketed product is Lymphoseek, which is the first and only FDA-approved receptor-targeted lymphatic mapping agent. Lymphoseek product revenue for 2015 is estimated to be in the range of $10 million to $12 million.

NAVB closed Monday's trading at $1.63, down 1.81%.

Shares of Ocata Therapeutics Inc. (OCAT) were up more than 9% on Monday, following the receipt of a Small Business Innovation Research, or SBIR, phase I grant to develop the company's proprietary Hemangio-derived Mesenchymal Cell product for the treatment of systemic lupus erythematosus and lupus nephritis.

The company completed dosing of its phase 1/2 studies of retinal pigment epithelium cells for dry age-related macular degeneration (AMD) and Stargardt's Macular Degeneration (SMD) in late first quarter 2015, and has made significant progress towards the initiation of a phase II study in dry AMD and a pivotal SMD study in the second half of 2015.

OCAT closed Monday's trading at $4.16, up 9.19%.