MCUR's VLU Trial Is Futile, CRBP, CEMP On Fast Track, INO Takes A Shot At MERS

(RTTNews) - BioMarin Pharmaceutical Inc.'s (BMRN) drug candidate Drisapersen, a potential treatment for patients with Duchenne Muscular Dystrophy who are amenable to exon 51 skipping treatment, has been granted a rare pediatric disease designation.

The NDA for Drisapersen is under priority review by the FDA, with a decision date set for December 27, 2015.

BMRN closed Wednesday's trading at $135.70, down 1.11%.

Cempra Inc.'s (CEMP) investigational product Solithromycin intravenous (IV) and capsules for the treatment of community acquired bacterial pneumonia has been granted Fast Track status by the FDA.

Solithromycin is currently in phase III development for the treatment of community acquired bacterial pneumonia and submission of a New Drug Application is planned for 2016.

Additional clinical studies with Solithromycin include a phase III trial in uncomplicated gonorrhea that is expected to complete patient enrollment by the end of 2015, a phase II trial in chronic obstructive pulmonary disease, a phase II trial in nonalcoholic steatohepatitis and a phase 1b trial in pediatric patients.

CEMP closed Wednesday's trading 5.22% higher at $38.70.

Corbus Pharmaceuticals Holdings Inc.'s (CRBP) investigational drug Resunab has been granted Fast Track status for systemic sclerosis.

Resunab is currently in a phase II clinical study in skin-predominant dermatomyositis and is scheduled to commence phase II clinical trials for the treatment of cystic fibrosis and diffuse cutaneous systemic sclerosis during this quarter.

CRBP closed Wednesday's trading at $2.50, up 34.41%.

The United States Patent and Trademark Office has granted a patent to INFAT, an innovative ingredient that is marketed by Advanced Lipids, a joint venture of AAK and Enzymotec Ltd. (ENZY), for uses related to intestinal development, maturation, adaptation and differentiation.

Developed specifically for infant formula, INFAT is a clinically-proven fat ingredient that closely resembles the composition, structure and nutritional value of natural fat in human breast milk that is necessary for proper infant health, development and comfort, Enzymotec said.

Last week, the company reported better-than-expected second quarter results - with net revenue increasing 49.5% and non-GAAP net income increasing 417.2% compared to the year-ago quarter.

Looking ahead to full fiscal year 2015, the company expects non-GAAP net income in the range of $6.5 million and $8.5 million or $0.28 and $0.36 per share, and net revenue in the range of $53 million and $59 million.

ENZY closed Wednesday's trading at $9, up 3.33%.

Immunomedics Inc. (IMMU) is slated to report interim results from a phase II study of Sacituzumab govitecan in patients with advanced, metastatic lung cancers in an oral presentation on September 7, 2015.

IMMU closed Wednesday's trading at $1.82, down 4.71%.

Inovio Pharmaceuticals' (INO) DNA vaccine targeting the virulent Middle East Respiratory Syndrome, or MERS, induced 100% protection from a live virus challenge in a preclinical study.

Given the fact that there is no vaccine or effective treatment for the MERS virus, which has infected 1,400 people and killed over 500 since 2012, it would be worth keeping an eye on Inovio's synthetic DNA-based MERS vaccine.

Recently, the largest outbreak outside of Saudi Arabia of this emergent global health concern infected 186 people with 36 fatalities in South Korea.

INO closed Wednesday's trading at $7.64, up 2.69%.

Macrocure Ltd.'s (MCUR) phase III pivotal clinical study of its lead product candidate CureXcell for venous leg ulcers is not expected to meet its primary endpoint, according to a pre-specified, futility analysis conducted by the Data Safety Monitoring Board.

CureXcell is a unique combination of living human white blood cells that have been activated to facilitate the healing process and stimulate wound closure.

The company said that it will evaluate the data collected to date in the venous leg ulcers study to determine an appropriate course of action, including the potential initiation of a third phase III study in patients with chronic wounds below the knee.

The company is scheduled to report top-line study results from its pivotal, phase III trial of CureXcell in Diabetic Foot Ulcers in October 2015. Stay tuned...

MCUR closed Wednesday's trading at $12.05, down 4.67%.