Ocuphire shares up, as NDA for Nyxol accepted by FDA

13 February 2023

Shares of US ophthalmic drug developer Ocuphire Pharma (Nasdaq: OCUP) were lifted 7.6% to $3.53 this morning, as the company updated on the development of its lead product candidate.

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM), Ocuphire revealed. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023.

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