Soothing Balm For Avita, NVAX Gets Booster Shot, RVNC On The Move

(RTTNews) - Medical device company Avita Medical Ltd. (AVMXY.OB) has been awarded a 5-year, $53.9 million contract by the Biomedical Advanced Research and Development Authority for the company's late-stage clinical development and procurement of ReCell Autologous Cell Harvesting Device, under a U.S. mass casualty preparedness program.

ReCell is a medical device that can be used in conjunction with conventional treatments for burns and reconstructive procedures.

The total procurement under the BARDA contract would cover more than 25,000 ReCell devices, the company noted.

AVMXY.OB closed Tuesday's trading at $1.09, up 1.87%.

Clovis Oncology Inc.'s (CLVS) New Drug Application for Rociletinib in the treatment of advanced EGFR-Mutant T790M+ non-small cell lung cancer has been accepted for priority review by the FDA - with a decision date set for March 30, 2016.

Additionally, the Marketing Authorization Application for Rociletinib is under accelerated assessment in Europe.

CLVS closed Tuesday's trading at $89.03, down 1.67%. In after ours, the stock was up 4.11% at $92.69.

Shares of Novavax Inc. (NVAX) were up more than 6% in extended trading on Tuesday, following positive top-line data from a phase 1 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in healthy children.

The trial was designed to evaluate the safety and immunogenicity of the RSV F Vaccine, with one or two doses, with or without aluminum phosphate adjuvant, in healthy pediatric participants two to six years of age.

NVAX closed Tuesday's trading at $6.41, down 21.35%. In after hours, the stock was up 6.08% at $6.80.

OXiGENE Inc. (OXGN) plans to conduct two new phase 2/3 randomized studies of its lead investigational drug, CA4P - one in ovarian cancer in the first half of 2016, and the other in glioblastoma multiforme in the second half of 2016.

The ovarian cancer trial will evaluate whether the addition of CA4P to standard of care, which is chemotherapy plus Avastin, improves patient outcomes. The glioblastoma multiforme trial will determine whether CA4P improves upon the current standard of care, which is treatment with Avastin alone.

OXGN closed Tuesday's trading at $1.10, down 6.78%. In after hours, the stock was up 6.36% to $1.17.

Revance Therapeutics Inc. (RVNC) has initiated a phase II trial of RT002 investigational drug product candidate to treat cervical dystonia, a neurological muscle movement disorder.

The trial will enroll about 36 patients with at least moderate cervical dystonia - with three treatment groups of approximately 12 patients each who will be treated with one of three doses of RT002 for injection. The company plans to release interim results in 2016.

RVNC closed Tuesday's trading at $27.78, up 5.75%.

Sanofi's (SNY) New Drug Application for Lixisenatide for the treatment of patients with Type 2 diabetes has been accepted for review by the FDA. The NDA for Lixisenatide was submitted by Sanofi in late July 2015, and the FDA's decision can be expected by July 2016.

Lixisenatide is currently available for adult patients in over 40 countries outside the U.S., marketed as Lyxumia by Sanofi under a global license agreement with Zealand Pharma.

SNY closed Tuesday's trading at $46.64, down 0.13%.

Vitae Pharmaceuticals Inc. (VTAE) has initiated the second part of its phase 1 multiple ascending dose clinical trial of VTP-43742 in psoriatic patients. The top-line clinical efficacy results are expected by the end of 2015.

VTAE closed Tuesday's trading at $10.62, down 3.45%.