ASPX Flies On Trial Data, CYCC Knocked Down, NVGN Creates Buzz, BVX On Watch

(RTTNews) - Auspex Pharmaceuticals Inc. (ASPX) surged more than 63 percent in extended trading on Tuesday after reporting positive topline results from its phase III registration trial evaluating SD-809 for the treatment of chorea associated with Huntington's disease.

Huntington disease is a complex and severely debilitating genetic, neurodegenerative disease that affects the body, the mind and the emotions. The disease affects 30,000 people in the US and about 70,000 worldwide. Xenazine (tetrabenazine) developed by Denmark-based H. Lundbeck A/S, is the only FDA-approved treatment for chorea associated with Huntington's disease.

Auspex expects to file a New Drug Application for SD-809 for the treatment of chorea associated with Huntington's disease by mid-2015.

ASPX closed Tuesday's trading 3.21% higher at $25.09. In after-hours, the stock was up 63.41% at $41.00.

Pet therapeutics company Aratana Therapeutics Inc. (PETX) has initiated a pivotal field effectiveness study for AT-003, the company's innovative drug for treating post-surgical pain in dogs.

AT-003, an extended release injectable formulation of bupivacaine, is licensed from Pacira Pharmaceuticals Inc. (PCRX). The study is designed to enroll approximately 150 client-owned dogs undergoing knee surgery, which will be given AT-003 or placebo.

PETX closed Tuesday's trading at $11.88, down 5.64%.

Bovie Medical Corp. (BVX) has received FDA clearance for Bovie Ultimate generator that can be used for delivery of RF energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures.

The Bovie Ultimate will replace Bovie's ICON GS plasma system. The company expects commercial launch of the new product in February, 2015.

The Bovie Ultimate generator offers users monopolar, bipolar and plasma features, including one J-Plasma helium gas outlet, in a single generator. It should be noted that the J-Plasma sales have increased substantially as the company continues to build a platform to accelerate and support future growth.

In the third quarter of 2014, J-Plasma sales were $90,514, twice the $45,000 reported for first half 2014.

BVX closed Tuesday's trading at $3.43, down 2.53%.

Shares of Cerus Corp. (CERS) were up more than 20 percent in extended trading on Tuesday following FDA approval of the company's INTERCEPT Blood System for plasma.

The INTERCEPT Blood System is meant to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The device is designed for three blood components namely, platelets, plasma and red blood cells.

The INTERCEPT plasma system is aimed at reducing the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.

The company completed the submission of Premarket Approval application process for INTERCEPT Blood System for platelets in the second quarter of this year, and is working with the FDA on reaching an approval decision.

The INTERCEPT Blood System for both platelets and plasma are already being sold by Cerus in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development.

CERS closed Tuesday's trading 3.02% higher at $4.78. In after-hours, the stock was up 20.92% at $5.78.

Cyclacel Pharmaceuticals Inc. (CYCC) plunged more than 75 percent on Tuesday after an interim analysis for futility of its phase III study of drug candidate Sapacitabine capsules in acute myeloid leukemia, found that it is unlikely for the study to reach statistically significant improvement in survival.

The Data and Safety Monitoring Board, or DSMB, conducted its planned interim analysis for futility after 247 events and the final safety review of 470 randomized patients. The DSMB found no safety concerns.

The company noted it will follow-up patients as per the study protocol until the prespecified 424 events have been observed, which is estimated to occur between the second half of 2015 and the first half of 2016.

The phase III study of oral Sapacitabine, dubbed SEAMLESS, is a registration-directed study of in elderly (70 years or older) patients with AML who are unfit for or have refused intensive chemotherapy from approximately 110 U.S. and European sites. SEAMLESS has enrolled 486 patients and is one of the largest studies in this population. The primary endpoint is overall survival.

CYCC closed Tuesday's trading at $0.67, down 75.98%.

Ipsen's (IPSEY.PK) Somatuline Depot Injection 120 mg, referred to as Somatuline, has received FDA approval for a new indication - this time, for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The approval was based on results from a phase III trial, dubbed CLARINET, in which Somatuline showed substantial clinical benefit in treating both pancreatic and gastrointestinal neuroendocrine tumors.

The company plans to launch Somatuline for the new indication in early 2015.

In 2007, Somatuline received FDA approval for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.

Shares of Novogen Ltd. (NVGN) skyrocketed more than 214 percent on Tuesday after the company confirmed that its lead product candidate, TRXE-009, originally developed for the treatment of brain cancers, has also found to be highly active against melanoma in pre-clinical studies.

According to the company, the new finding is an important breakthrough discovery for two reasons - one, for confirming that TRXE-009 is an important new potential treatment for melanoma and the other for offering evidence for the first time of an hypothesized link between brain cancer and melanoma.

TRXE-009 belongs to the class of super-benzopyrans, which have the potent ability to kill cancer stem cells. TRXE-009 is delivered in a construct in order to optimize the bioavailability of the drug candidate. The entire construct is known as Trilexium.

Novogen is planning to bring Trilexium into the clinic for the treatment of glioblastoma multiforme, a form of brain cancer, as soon as it is successful in raising funds specifically ear-marked for this project.

NVGN closed Tuesday's trading 214.62% higher at $5.38.