TKMR Stays Focused On Ebola, GEVA Sets Work Rolling, FDA Panel Nod For VRTX

(RTTNews) - ChemoCentryx Inc.'s (CCXI) phase I trial of CCX507 has demonstrated that the compound is safe and well tolerated in healthy volunteers at all doses tested.

CCX507 is being evaluated for treatment of patients with inflammatory bowel diseases including ulcerative colitis, and primary sclerosing cholangitis.

The company plans to move CCX507 forward in phase II clinical trials, potentially in conjunction with a strategic partner.

CCXI closed Tuesday's trading at $5.56, up 4.12%.

Synageva BioPharma Corp. (GEVA) has commenced the rolling submission of its Biologics License Application to the FDA for Sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency or LAL deficiency in short.

LAL deficiency is a rare genetic disease with significant morbidity and early mortality.

The company anticipates completing the rolling submission of the Sebelipase alfa BLA to the FDA and submitting the Marketing Authorization Application to the European Medicines Agency by the end of January 2015.

GEVA closed Tuesday's trading at $73.14, down 1.30%. In extended trading, the stock was up 1.31% to $74.10.

Tekmira Pharmaceuticals Corp. (TKMR) (TKM.TO) has commenced limited Good Manufacturing Practice, or GMP, manufacture of a new therapeutic specifically targeting the Ebola - Guinea variant, which is the viral variant responsible for the Ebola epidemic currently prevalent in West Africa.

The supply of the new therapeutic will be available in early December, 2014, for potential use by various collaborators, noted the company.

TKMR closed Tuesday's trading at $17.98, down 3.39%. In after-hours, the stock was up 4.62% to $18.81.

Tonix Pharmaceuticals Holding Corp. (TNXP) is all set to study its drug candidate TNX-201, designed for the treatment of episodic tension-type headache, in healthy volunteers. The study is scheduled to be completed before the end of 2014.

The company is also preparing to initiate a phase III program of TNX-102 SL in fibromyalgia and begin a phase 2 trial of TNX-102 SL in post-traumatic stress disorder in the fourth quarter of 2014.

TNXP closed Tuesday's trading at $5.76, up 6.47%.

The FDA's Pulmonary Allergy Drugs Advisory Committee has voted 13-2 to recommend approval of Vertex Pharmaceuticals Inc.'s (VRTX) marketed cystic fibrosis drug KALYDECO for expanded use in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory (CFTR) gene.

In the U.S., KALYDECO is already approved to treat people ages 6 and older who have specific mutations like G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D in the CFTR gene.

The FDA's final decision related to the expanded use of KALYDECO is expected by December 30, 2014.

KALYDECO logged in net revenues of $371.3 million last year. The drug is expected to generate net revenues of $470 million to $500 million in 2014.

VRTX closed Tuesday's trading 3.24% higher at $108.16. In after-hours, the stock gained another 1.29% to $109.55.