23:40 , Jul 7, 2017 |  BioCentury  |  Finance

Onward and upward

The top three market cap tiers continued to outperform smaller caps in 2Q17, led by companies valued between $1 billion and $9.9 billion. Companies valued below $1 billion failed to carry over their momentum from...
19:19 , Jun 2, 2017 |  BC Week In Review  |  Clinical News

FDA approves Nicox’s Zerviate for ocular itching

Nicox S.A. (Euronext:COX) said FDA approved an NDA for Zerviate cetirizine (AC-170) to treat ocular itching associated with allergic conjunctivitis. The approval is Nicox's first in the U.S. Last October, FDA issued a complete response...
23:05 , May 31, 2017 |  BC Extra  |  Company News

Nicox’s Zerviate wins FDA nod for ocular itching

Nicox S.A. (Euronext:COX) jumped €2.26 (21%) to €12.85 Wednesday after FDA approved an NDA for Zerviate cetirizine to treat ocular itching associated with allergic conjunctivitis. The approval is Nicox's first in the U.S. In October...
20:09 , Mar 10, 2017 |  BC Week In Review  |  Clinical News

Zerviate regulatory update

Nicox resubmitted an NDA to FDA for Zerviate cetirizine to treat ocular itching associated with allergic conjunctivitis. Last year, FDA issued a complete response letter to Nicox for the product due to concerns related to...
07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

Cetirizine regulatory update

FDA issued a complete response letter to Nicox for AC-170 to treat ocular itching associated with allergic conjunctivitis. The company said the letter related “solely” to a GMP inspection at a third-party facility producing AC-170’s...
07:00 , Oct 10, 2016 |  BC Extra  |  Company News

Nicox's eye drop gets complete response letter

Nicox S.A. (Euronext:COX) received a complete response letter from FDA for AC-170 to treat ocular itching associated with allergic conjunctivitis. The company said the letter related "solely" to a GMP inspection at a third party...
07:00 , Jul 11, 2016 |  BioCentury  |  Finance

Rethinking risk

Steve Edelson, Senior Editor   The second half does not contain the high-impact, sector-moving milestones seen in the first six months of the year, but investors still have at least 90 late-stage milestones from which...
07:00 , Jun 27, 2016 |  BC Week In Review  |  Clinical News

Cetirizine regulatory update

FDA accepted and granted Priority Review to an NDA from Nicox for AC-170 to treat ocular itching associated with allergic conjunctivitis. The PDUFA date is Oct. 18. The product is a topical formulation of cetirizine,...
00:15 , Jun 22, 2016 |  BC Extra  |  Company News

Priority Review for Nicox's eye drop

Nicox S.A. (Euronext:COX) said FDA accepted and granted Priority Review to an NDA for AC-170 , the company's topical formulation of cetirizine, to treat ocular itching associated with allergic conjunctivitis. Its PDUFA date is Oct....
07:00 , Apr 25, 2016 |  BC Week In Review  |  Clinical News

Cetirizine regulatory update

Nicox’s Nicox Ophthalmics Inc. subsidiary submitted an NDA to FDA and requested Priority Review for AC-170 to treat ocular itching associated with allergic conjunctivitis. The product is a topical formulation of cetirizine, a histamine H1...