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Ocuphire Pharma, Inc. (Nasdaq: OCUP) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing small-molecule therapies for retinal and refractive eye disorders. Focused on addressing unmet medical needs in ocular diseases, Ocuphire's innovative pipeline includes two main product candidates: Nyxol and APX3330.
Nyxol (phentolamine ophthalmic solution 0.75%) is in advanced clinical development for various indications. It was approved by the FDA under the brand name RYZUMVI™ in September 2023 for the reversal of pharmacologically-induced mydriasis. Nyxol is also in Phase 3 clinical trials for the treatment of presbyopia and decreased visual acuity under low light (mesopic) conditions following keratorefractive surgery.
APX3330 is an oral small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) aimed at treating diabetic retinopathy (DR) and diabetic macular edema. APX3330 has shown promise in slowing DR progression and is poised to enter Phase 2/3 pivotal trials, following a successful Phase 2 study and productive discussions with the FDA regarding Special Protocol Assessment.
Ocuphire’s experienced management team boasts over 100 years of combined drug development expertise across ophthalmology, orphan diseases, cardiology, nephrology, oncology, and respiratory diseases. The company is also exploring additional delivery routes and second-generation Ref-1 inhibitors, such as APX2009 and APX2014, for treating other retinal diseases like age-related macular degeneration and geographic atrophy.
Ocuphire's strategic partnership with Viatris, Inc. strengthens its commercial potential. Viatris collaborates with Ocuphire in developing and marketing Nyxol and other product candidates. Recent financial highlights reveal Ocuphire's robust fiscal health, with cash reserves expected to fund operations into mid-2025, bolstered by significant milestones and collaboration revenue.
For more information, visit www.ocuphire.com.
Ocuphire Pharma (NASDAQ: OCUP) announced CEO Mina Sooch will present at three conferences: Benzinga Healthcare Small Cap Conference on September 29-30, Ophthalmology Futures Forums on October 7, and Alliance Global Partners Biotech & Specialty Pharma Conference on October 13, 2021. Ocuphire aims to develop therapies for eye disorders, including their lead product, Nyxol®, which has positive clinical trial results for various indications including reversal of mydriasis. The company also continues to explore partnerships for its development pipeline.
Ocuphire Pharma (Nasdaq: OCUP) has announced the approval of an equity award for a new employee, effective September 1, 2021. The award, which complies with Nasdaq Listing Rule 5635(c)(4), includes an option to purchase 45,000 shares at an exercise price of $4.49 each. The option, which vests over four years, reflects the company's strategy to attract talent and align interests. Ocuphire focuses on developing therapies for eye disorders, with its lead candidate, Nyxol, addressing various vision-related conditions. For further details, visit ocuphire.com.
Ocuphire Pharma (Nasdaq: OCUP) will present corporate overviews at various virtual healthcare conferences in September 2021. CEO Mina Sooch will speak at the Euro Forums 2021 Virtual Retina Forum on September 8, followed by the HC Wainwright Annual Conference on September 13, the Oppenheimer Summit on September 21, and the Cantor Global Healthcare Conference on September 28. Ocuphire, a clinical-stage ophthalmic biopharmaceutical company, focuses on therapies for refractive and retinal disorders, with key products in development for several eye conditions.
Ocuphire Pharma (Nasdaq: OCUP) reports strong progress in clinical trials, particularly with positive top-line results from the VEGA-1 Phase 2 trial, which successfully evaluated Nyxol in combination with low-dose pilocarpine for presbyopia, meeting its primary endpoint of 3 lines of near vision improvement.
The company maintains a cash balance of $24 million as of June 30, 2021, providing a financial runway into late 2022 to facilitate upcoming NDA submissions for Nyxol.
Ocuphire Pharma (Nasdaq: OCUP) will participate in two virtual conferences in August 2021. CEO Mina Sooch will host a fireside chat at the Canaccord Genuity 41st Annual Growth Conference on August 12 and hold one-on-one meetings. She will then present a corporate overview at the HC Wainwright Ophthalmology Virtual Conference on August 17, featuring positive Phase 2 data from the Nyxol program for presbyopia and updates on the oral candidate APX3330. Ocuphire's lead product, Nyxol, targets various eye disorders, with ongoing Phase 3 trials for night vision disturbances.
Ocuphire Pharma (Nasdaq: OCUP) has highlighted the safety and efficacy of its oral compound, APX3330, targeting diabetic retinopathy. A published commentary in the Journal of Cellular Signaling underscores APX3330's dual mechanism in blocking inflammation and abnormal blood vessel growth. The ongoing Phase 2 ZETA-1 trial aims to measure the drug's impact on diabetic retinopathy severity scores, with results anticipated in 2022. Ocuphire's strategy includes exploring further ophthalmic assets and partnerships for advanced development.
Ocuphire Pharma, focusing on ophthalmic therapies, announced presentations at the 2021 ASCRS Annual Meeting. Dr. Jay S. Pepose will present data on presbyopia and mydriasis reversal studies. CEO Mina Sooch will also participate in industry panels. Ocuphire reports positive data from Phase 2 VEGA-1 for presbyopia and Phase 3 MIRA-2 for mydriasis reversal, indicating potential for Nyxol to be a leading treatment. The company aims for NDA submission for Nyxol in late 2022 as part of its strategy to develop innovative eye care solutions.
Ocuphire Pharma (Nasdaq: OCUP) announced the approval of an equity award for Amanda Providakes as a part of her employment effective July 6, 2021. The award includes options to purchase 4,000 shares at an exercise price of $4.51 per share, reflecting the closing stock price on the grant date. These options have a ten-year term and vest over four years. Ocuphire is focused on developing therapies for eye disorders, with lead candidate Nyxol having positive trial data. The company is also advancing its second candidate, APX3330, in clinical trials.
Ocuphire Pharma (NASDAQ: OCUP) announced successful results from its VEGA-1 Phase 2 clinical trial for Nyxol in combination with low-dose pilocarpine (LDP) for treating presbyopia. The trial met its primary endpoint, showing that 61% of subjects achieved a significant improvement in near vision. Key secondary endpoints also demonstrated statistical significance. The combination therapy exhibited a favorable safety profile, with plans to advance into Phase 3 registration trials in 2022. This positions Nyxol as a potential leading treatment for presbyopia, addressing a significant unmet need.
Ocuphire Pharma (NASDAQ: OCUP) announced its inclusion in the Russell Microcap® Index, effective June 28, 2021. This membership, lasting one year, enhances the company's visibility within the global investment community, according to CEO Mina Sooch. Ocuphire is advancing its late-stage clinical programs for Nyxol® and APX3330, with plans for an NDA submission. The Russell indexes are significant benchmarks for approximately $10.6 trillion in assets, reflecting Ocuphire's growth trajectory and engagement in clinical trials for eye disorders.
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