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Ocuphire Pharma Inc OCUP

Ocuphire Pharma, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders. The Company’s lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref1 is a regulator of transcription factors such as HIF-1a and NF-B. The Inhibiting REF-1 reduces levels of vascular endothelial growth factor (VEGF) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet to be administered twice per day for the treatment of DR. The Company’s pipeline candidates include APX2009 and APX2014. The Company is initially pursuing APX3330 for the DR indication as first-line therapy and may explore opportunities for clinical benefit as monotherapy or adjunctive therapy for other retinal indications such as DME, wAMD, and GA.


NDAQ:OCUP - Post by User

Post by joebravoon Sep 13, 2023 8:57am
124 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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