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Ocuphire Pharma submits NDA to FDA for Nyxol

Ocuphire Pharma announced the submission of a New Drug Application to the U.S. FDA for Phentolamine Ophthalmic Solution 0.75% (Nyxol) for the reversal of pharmacologically-induced mydriasis produced by adrenergic agonist or parasympatholytic agents, or a combination thereof. Ocuphire has received the $35M upfront payment under the license agreement. Combined with its previous reported cash balance of $13.9M at Sept 30, 2022, the company believes that it has sufficient capital to fund operations into 2025, including advancing development of APX3330. If Nyxol is approved for RM in the US, Ocuphire is eligible to receive a $10M milestone payment.

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