Nicox Stock Dips As Partner Bausch + Lomb Of Valeant Gets CRL From FDA

(RTTNews) - Shares of Nicox S.A. (NICXF.PK) declined around 7 percent in the morning trading in Paris after the French ophthalmic company announced Friday that its partner Bausch + Lomb has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration, concerning latanoprostene bunod.

Earlier in the day, Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO), the parent of Bausch + Lomb, said in a statement that the CRL was received regarding the New Drug Application or NDA for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

FDA has raised concerns regarding a Current Good Manufacturing Practice or CGMP inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA.

Valeant noted that the FDA's letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant said it intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.

In Paris, Nicox shares are currently trading at 11.75 euros, down 7.19 percent.