FDA Says No To Nicox, Lundbeck's Persistence Pays Off, It's A Win For LPCN

(RTTNews) - Nicox S.A.'s (NICXF.OB) (COX.PA) AC-170, a proprietary cetirizine eye drop formulation, proposed for the treatment of ocular itching associated with allergic conjunctivitis has been turned down by the FDA.

In its Complete Response Letter, the FDA has cited solely the Good Manufacturing Practice at third party active pharmaceutical ingredient supplier facility as the reason for not approving AC-170.

The regulatory agency's decision on AC-170 was originally slated for October 18, 2016. The company plans to resubmit the AC-170 NDA after addressing the concerns raised by the FDA in the Complete Response Letter.

NICXF.OB closed Friday's trading at $9.25, down 6.05%.

The FDA, on Friday, approved H. Lundbeck A/S' (HLUKF.OB) Carnexiv injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible.

Carnexiv injection was issued a Complete Response Letter by the FDA in 2014. The company re-submitted the NDA for Carnexiv injection in April of this year.

Carnexiv is expected to be commercially available in the United States in early 2017. Following the approval, Lundbeck's partner Ligand Pharmaceuticals Inc. (LGND) has earned a $1.25 million milestone payment, and is also entitled to receive a royalty of 2.75% on net sales of Carnexiv.

HLUKF.OB closed Friday's trading at $35.00, unchanged from the previous day's close.

Genmab A/S' (GNMSF.OB) supplemental Biologics License Application for DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for relapsed multiple myeloma has been granted priority review by the FDA, and a decision date has been set for February 17, 2017.

The company's supplemental Biologics License Application for DARZALEX in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma has been granted standard review, with a decision date set for June 17, 2017.

GNMSF.OB closed Friday's trading at $158.25.

Shares of Lipocine Inc. (LPCN) surged over 29% on Friday after a Court agreed to dismiss a patent infringement lawsuit related to LPCN 1021 filed against it by Clarus Therapeutics Inc.

LPCN 1021 is Lipocine's oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

The FDA issued a Complete Response Letter for Lipocine's LPCN 1021 in June of this year. The company is working towards addressing the concerns raised by the FDA in the Complete Response Letter.

LPCN closed Friday's trading 29.74% higher at $5.41.