forse non vi siete accorti di questo.....perdonati....anche il mercato non si è accorto di nulla !!! altri titoli avrebbero fatto +20%.....
Nicox: Vesneo, AC-170 On Track For NDA Submission In US - Quick Facts
6/3/2015 2:08 AM ET
Nicox S.A. (NICXF.PK,COX.PA), a French ophthalmic company, Wednesday announced that lead clinical candidates Vesneo and AC-170 are on track for New Drug Application or NDA submission in the United States.
In its update ahead of its Ordinary and Extraordinary Shareholder Meetings today, Nicox said that its licensee Bausch + Lomb, a unit of Valeant Pharmaceuticals International Inc. (VRX,VRX.TO) remains on track to submit an NDA to the US Food and Drug Administration or FDA for Vesneo (latanoprostene bunod). An announcement is expected once the NDA submission has been accepted for filing by the FDA, which normally takes place around 60 days following submission.
The NDA submission for AC-170, a novel formulation of cetirizine developed for the treatment of ocular itching associated with allergic conjunctivitis, also remains on track. Nicox's objective is to obtain FDA approval by the end of 2016.
Nicox noted that its advanced pipeline also features two pre-MAA (Marketing Authorization Application) candidates in Europe: AzaSite for bacterial conjunctivitis and BromSite for pain and inflammation after cataract surgery. Nicox now expects to submit European MAAs for both candidates by the end of the first half of 2016.
Based on the positive phase 3 results for Vesneo and increased interest in the potential of nitric oxide (NO)-donors in ophthalmology, Nicox's Board of Directors has selected NCX 470 as the Company's lead follow-on glaucoma candidate for internal development.
Nicox's research team will also continue to work on two other nitric oxide donor programs.