SRPT's Anxious Wait To Continue, ZFGN Has Reason To Flaunt, OGXI Disappoints

(RTTNews) - AmpliPhi Biosciences Corp. (APHB) has dosed the first patient in its phase I clinical trial of AB-SA01 for the treatment of Staphylococcus aureus infections in patients with chronic rhinosinusitis that fail to respond to standard antibiotic treatment.

Chronic rhinosinusitis is a serious, often debilitating infection and inflammation of the nose and sinuses lasting 12 weeks or more.

AmpliPhi expects to complete enrollment of the trial by the end of the first half of 2016.

APHB closed Wednesday's trading 28.45% higher at $2.98.

Shares of OncoGenex Pharmaceuticals Inc. (OGXI) were down over 32% in extended trading on Wednesday, following failure of a phase II trial of the company's drug candidate Apatorsen in combination with chemotherapy drugs Carboplatin and Pemetrexed in patients with untreated metastatic non-small cell lung cancer.

The trial, dubbed Spruce, did not reach the statistical significance required to demonstrate a progression-free survival benefit. The study is ongoing and overall survival results are expected in the second half of 2016.

OGXI closed Wednesday's trading at $0.75, up 5.07%. In after hours, the stock was down 32.60% to $0.50.

Sarepta Therapeutics Inc.'s (SRPT) New Drug Application for Eteplirsen, an experimental drug for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, is NOT going to be reviewed by an FDA panel on January 22, 2016 as the Advisory Committee meeting has been postponed due to an anticipated severe winter snowstorm forecasted to hit the Washington D.C. area.

The company said that a future meeting date will be announced in the Federal Register. In the event of a change in the FDA decision date of February 26, 2016, an update will be provided at that time, added the company.

SRPT closed Wednesday's trading at $13.26, down 1.34%. In after hours, the stock was down 1.96% to $13.05.

Stellar Biotechnologies Inc. (SBOT) (KLH.V) and France-based Neovacs S.A. are planning to form a joint venture for the manufacture of conjugated therapeutic vaccines using Stellar's proprietary Keyhole Limpet Hemocyanin.

The proposed Joint Venture aims to produce Neovacs' Kinoid product candidates, including IFNa-Kinoid, as well as potentially manufacture other KLH-based immunotherapies on behalf of third party customers.

As per the proposal, Neovacs will hold a 70% stake in the Joint Venture while Stellar will own the remaining 30% interest.

SBOT closed Wednesday's trading at $5.32, down 9.83%.

Shares of Zafgen (ZFGN) soared more than 78% on Wednesday, following positive efficacy results from a phase III trial evaluating its drug candidate Beloranib in patients with Prader-Willi syndrome.

In the trial, dubbed bestPWS ZAF-311, Beloranib demonstrated a statistically significant reduction in both body weight and hyperphagia-related behaviors during a six-month randomized treatment period.

Prader-Willi syndrome, or PWS, is the most common known genetic cause of life-threatening obesity. Many of those affected with PWS become morbidly obese and suffer significant mortality. Currently, there is no cure for this disease.

Beloranib becomes the first investigational drug to demonstrate a positive impact on the two hallmark challenges in PWS - body weight and *hyperphagia-related behaviors (*hyperphagia means abnormally large appetite for food).

The company plans to provide data from a phase IIb trial of Beloranib in severe obesity complicated by type 2 diabetes later this quarter.

ZFGN closed Wednesday's trading at $10.04, up 78.65%. In after hours, the stock was up 1.79% to $10.22.