BC Week In Review | Mar 14, 2019
Clinical News

Adare’s APT-1011 meets in Phase IIb for eosinophilic esophagitis

Adare said it plans to start a Phase III program next half of APT-1011 (AdvaTab Fluticasone) to treat eosinophilic esophagitis after reporting that the product met the primary endpoint in the Phase IIb FLUTE trial...
BioCentury | Jul 7, 2017
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...
BC Week In Review | Jun 2, 2017
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...
BC Extra | May 31, 2017
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...
BC Week In Review | Mar 10, 2017
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...
BC Week In Review | Oct 17, 2016
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...
BC Extra | Oct 10, 2016
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...
BioCentury | Jul 11, 2016
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...
BC Week In Review | Jun 27, 2016
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,...
BC Extra | Jun 22, 2016
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. 18....
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