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Opus Genetics Inc IRD

Opus Genetics, Inc., formerly Ocuphire Pharma, Inc., is a clinical-stage ophthalmic biopharmaceutical company. The Company is engaged in developing therapies to treat patients with inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders. Its pipeline includes adeno-associated virus (AAV)-based gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. Its most advanced gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and being evaluated in a Phase I/II open-label, dose-escalation trial, with advancing early data. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1 to slow the progression of non-proliferative diabetic retinopathy.


NDAQ:IRD - Post by User

Post by joebravoon Sep 13, 2023 8:57am
190 Views
Post# 35633373

FDA PDUFA Date September 28, 2023

FDA PDUFA Date September 28, 2023Not sure why this board has very little following, but this little company with a small float of 21 million shares is about to receive a FDA decision in 2 weeks which could potentially double their share price if they receive approval.

Ocuphire has $40 million in cash and will receive another $10 million in milestone payment from Viatras, their partner, if Nyxol RM (Reversal of Mydriasis) is approved Sept. 28.

Viatris, a global pharma, is paying all costs of commercialization, including any further testing for other applications of Nyxol.  They will pay, upon FDA approval and commerialization of Nyxol a double digit Royalty to Ocuphire on "Net Sales".

The share price has been channeling in the $4 range since May, and depending on the FDA decision, should break out either way.  I'm expecting approval.  Do some DD on this one as it could be a great long term play with exponential share price appreciation.

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