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Here's Why You Should Invest in Ocuphire Pharma (OCUP) Now
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Ocuphire Pharma’s lead retinal pipeline candidate is APX3330, a small-molecule inhibitor of Ref-1 protein, which is being developed as a twice-daily oral tablet for the treatment of diabetic retinopathy (“DR”), a leading cause of blindness. A phase II study evaluating APX3330 for DR has been completed.
Ocuphire Pharma has achieved important regulatory milestones in recent months, mainly in relation to advancing APX3330 to late-stage development. It had a successful end-of-phase II meeting with the FDA and reached an agreement on the primary endpoint of phase III. Ocuphire Pharma plans to finalize the protocol and statistical analysis plan with the FDA for the first phase III study through a Special Protocol Assessment submission.
Ref-1 inhibitors have a unique dual mechanism of action as they reduce levels of vascular endothelial growth factor (“VEGF”) glycoprotein and inflammatory cytokines, which are key factors that cause ocular angiogenesis and inflammation. APX3330 normalizes the levels of VEGF by inhibiting REF-1 and brings it back to physiologic levels, unlike biologic ocular medicines, which reduce VEGF levels below that required for normal function.
Ocuphire Pharma’s stock has risen 24.4% in the past month compared with an increase of 11.3% for the industry.
Image Source: Zacks Investment Research
Per the company, DR affects approximately 10 million people with diabetes and is projected to impact over 14 million Americans by 2050. APX3330 has been developed as an oral tablet, which has the potential to improve patient convenience by offering them an oral treatment option compared to frequent eye injections required with currently approved anti-VEGF therapies for the disease.
If approved, APX3330 has the potential to be the first non-invasive early treatment to delay or prevent vision-threatening complications in patients with non-proliferative DR. Non-proliferative DR is the early stage of the disease. Treatment with APX3330 can potentially slow the progression of non-proliferative DR to proliferative DR, which is the more advanced stage of the disease that can cause loss of vision.
Ocuphire also has a partnership with Viatris (VTRS - Free Report) to develop and commercialize Ryzumvi (phentolamine ophthalmic solution) 0.75% eye drops for the reversal of pharmacologically induced mydriasis. Ryzumvi was approved by the FDA in September 2023 and is expected to be commercially launched by Viatris in the United States in the first half of 2024. Ocuphire received a $10 million milestone payment from Viatris upon Ryzumvi’s approval.
Ocuphire and Viatris are also developing Ryzumvi for the treatment of presbyopia and dim light (night) vision disturbances. A phase III study on Ryzumvi for presbyopia met its primary endpoint, and Viatris is expected to continue the phase III development in the first half of 2024
Some other top-ranked biotech companies are Regeneron Pharmaceuticals (REGN - Free Report) and Puma Biotechnology (PBYI - Free Report) , sporting a Zacks Rank #1 each.
In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.66 per share. Regeneron’s stock has surged 26.9% in the past year.
Regeneron beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 1.8%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Here's Why You Should Invest in Ocuphire Pharma (OCUP) Now
Ocuphire Pharma’s lead retinal pipeline candidate is APX3330, a small-molecule inhibitor of Ref-1 protein, which is being developed as a twice-daily oral tablet for the treatment of diabetic retinopathy (“DR”), a leading cause of blindness. A phase II study evaluating APX3330 for DR has been completed.
Ocuphire Pharma has achieved important regulatory milestones in recent months, mainly in relation to advancing APX3330 to late-stage development. It had a successful end-of-phase II meeting with the FDA and reached an agreement on the primary endpoint of phase III. Ocuphire Pharma plans to finalize the protocol and statistical analysis plan with the FDA for the first phase III study through a Special Protocol Assessment submission.
Ref-1 inhibitors have a unique dual mechanism of action as they reduce levels of vascular endothelial growth factor (“VEGF”) glycoprotein and inflammatory cytokines, which are key factors that cause ocular angiogenesis and inflammation. APX3330 normalizes the levels of VEGF by inhibiting REF-1 and brings it back to physiologic levels, unlike biologic ocular medicines, which reduce VEGF levels below that required for normal function.
Ocuphire Pharma’s stock has risen 24.4% in the past month compared with an increase of 11.3% for the industry.
Image Source: Zacks Investment Research
Per the company, DR affects approximately 10 million people with diabetes and is projected to impact over 14 million Americans by 2050. APX3330 has been developed as an oral tablet, which has the potential to improve patient convenience by offering them an oral treatment option compared to frequent eye injections required with currently approved anti-VEGF therapies for the disease.
If approved, APX3330 has the potential to be the first non-invasive early treatment to delay or prevent vision-threatening complications in patients with non-proliferative DR. Non-proliferative DR is the early stage of the disease. Treatment with APX3330 can potentially slow the progression of non-proliferative DR to proliferative DR, which is the more advanced stage of the disease that can cause loss of vision.
Ocuphire also has a partnership with Viatris (VTRS - Free Report) to develop and commercialize Ryzumvi (phentolamine ophthalmic solution) 0.75% eye drops for the reversal of pharmacologically induced mydriasis. Ryzumvi was approved by the FDA in September 2023 and is expected to be commercially launched by Viatris in the United States in the first half of 2024. Ocuphire received a $10 million milestone payment from Viatris upon Ryzumvi’s approval.
Ocuphire and Viatris are also developing Ryzumvi for the treatment of presbyopia and dim light (night) vision disturbances. A phase III study on Ryzumvi for presbyopia met its primary endpoint, and Viatris is expected to continue the phase III development in the first half of 2024
Ocuphire Pharma sports a Zacks Rank #1 (Strong Buy) currently. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the loss per share estimate for Ocuphire Pharma for 2024 has narrowed from 79 cents per share to 57 cents per share.
Ocuphire Pharma beat estimates in three of the last four quarters, while missing in one, delivering an average earnings surprise of 59.28%.
Ocuphire Pharma, Inc. Price and Consensus
Ocuphire Pharma, Inc. price-consensus-chart | Ocuphire Pharma, Inc. Quote
Other Stocks to Consider
Some other top-ranked biotech companies are Regeneron Pharmaceuticals (REGN - Free Report) and Puma Biotechnology (PBYI - Free Report) , sporting a Zacks Rank #1 each.
In the past 60 days, estimates for Regeneron’s 2024 earnings have risen from $41.57 per share to $43.66 per share. Regeneron’s stock has surged 26.9% in the past year.
Regeneron beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 12.34%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 1.8%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.