D-Day For TBRA, Nicox Falls As FDA Rejects Vesneo, EXEL Awaits EMA Decision

(RTTNews) - The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Exelixis Inc.'s (EXEL) Cabometyx for the treatment of advanced renal cell carcinoma in adults following prior vascular endothelial growth factor-targeted therapy.

The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland, with a decision expected two months post CHMP opinion.

Cabometyx was approved by the FDA as recently as April 25, 2016.

In clinical trials, Cabometyx when compared with Novartis's (NVS) Afinitor, the widely used therapy for metastatic or advanced renal cell carcinoma, was associated with a 42 percent reduction in the rate of disease progression or death.

EXEL closed Friday's trading at $8.68, up 1.05%.

Shares of Nicox SA (NICXF.PK) were down over 9% on Friday, following the FDA's Complete Response Letter issued for Vesneo, an intraocular pressure lowering single-agent eye drop, proposed for patients with open angle glaucoma or ocular hypertension.

Vesneo is licensed to Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) wholly owned subsidiary, Bausch + Lomb.

In its Complete Response Letter, the FDA has raised concerns pertaining to a Current Good Manufacturing Practice inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where it identified some deficiencies. No efficacy or safety concerns have been raised with respect to the NDA nor are additional clinical trials needed for the approval.

NICXF.PK closed Friday's trading at $12.70, down 9.48%.

Tobira Therapeutics Inc. (TBRA) is all set to hold a teleconference and webcast at 8:30 a.m. Eastern Time today (July 25) to discuss phase IIb results for Cenicriviroc in patients with non-alcoholic steatohepatitis and liver fibrosis.

The study is known as CENTAUR, and its primary endpoint is a two-point improvement in NAS (NAFLD Activity Score) without progression of fibrosis.

Will Cenicriviroc make a mark? We will have to wait for the results.

TBRA closed Friday's trading at $11.25, up 2.65%.