Ocuphire Pharma Inc Stock Price, News & Analysis

Ocuphire Pharma (NASDAQ: OCUP) reports progress in its clinical development for two ophthalmic candidates: Nyxol and APX3330. Nyxol is advancing towards NDA filing for reversal of mydriasis in late 2022 and presbyopia treatment with promising Phase 2 results showing significant efficacy and durability. APX3330 shows a favorable safety profile in diabetic patients, with ~70% enrollment in the ZETA-1 Phase 2b trial.

Upcoming milestones include expected data releases in 2022 for both candidates and pre-commercial activities for Nyxol.

Ocuphire Pharma (Nasdaq: OCUP) announced a virtual Investor R&D Day on January 31, 2022, from 10:00 am to 12:15 pm ET. The event will feature six ophthalmic Key Opinion Leaders discussing Ocuphire's late-stage clinical trials for Nyxol® and APX3330. Key topics include Nyxol's efficacy in reversing mydriasis and targeting presbyopia, along with APX3330’s potential for diabetic retinopathy. The agenda includes presentations on recent clinical data, future catalysts like NDA submission, and market dynamics. This gathering aims to provide insights into Ocuphire's innovative therapies and their commercial prospects.

Ocuphire Pharma (Nasdaq: OCUP) announced the completion of enrollment in its LYNX-1 Phase 3 trial for Nyxol in Night Vision Disturbances (NVD) and the initiation of the MIRA-4 pediatric study for Reversal of Mydriasis (RM). Positive results from the MIRA-3 trial are crucial for an NDA submission later in 2022. The company has a strong cash position of approximately $24.5 million, extending its operational runway into Q2 2023. Upcoming milestones include MIRA-3 results and the launch of Phase 3 trials for presbyopia and diabetic retinopathy.

Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company, has appointed six new key opinion leaders to its Medical Advisory Board. This includes renowned specialists such as David Brown and Y. Ralph Chu, who bring extensive experience in ophthalmology. The new KOLs are expected to enhance Ocuphire's clinical trial designs and regulatory interactions, supporting the development of their lead candidates, Nyxol and APX3330. The appointment aims to address unmet medical needs in ophthalmic treatments, potentially broadening the company's market reach and clinical capabilities.

Ocuphire Pharma (NASDAQ: OCUP) announced the enrollment of the first subjects in its MIRA-3 Phase 3 trial for Nyxol Eye Drops, aimed at reversing pharmacologically-induced mydriasis. The trial involves approximately 330 subjects, with top-line results expected by early 2022. Previous trials demonstrated Nyxol's efficacy, where 50% of patients returned to baseline pupil size within 90 minutes. The reversal market is estimated at over $500M, with strong patient interest. Ocuphire is targeting a commercial launch of Nyxol in late 2022 and has engaged with Oculos Development Services for trial execution.

Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company, reported progress in its late-stage clinical programs during Q3 2021. They achieved positive results from two Phase 3 trials for Nyxol in reversal of mydriasis and initiated a second trial. Financially, the company had $22.2 million in cash as of September 30, 2021, with a net loss of $4.2 million for Q3. Future milestones include additional Phase 3 trials and an NDA submission for Nyxol by late 2022. Ocuphire remains optimistic about the value their therapies can create for shareholders.

Ocuphire Pharma (NASDAQ: OCUP) announced a significant development with the upcoming Phase 3 trials for its presbyopia treatment, Nyxol, slated to begin in the first half of 2022. This follows positive results from the VEGA-1 Phase 2 trial, where 61% of participants achieved a notable improvement in near vision. The company also plans to present clinical data on its other candidate, APX3330, at the American Academy of Ophthalmology (AAO) annual meeting later this month. This positions Ocuphire for potential growth in the ophthalmic market, addressing the needs of over 120 million Americans suffering from presbyopia.

Ocuphire Pharma (NASDAQ: OCUP) has published two review articles emphasizing the role of the APE1/Ref-1 protein in neovascular eye diseases, especially diabetic retinopathy and age-related macular degeneration. The articles highlight Ocuphire’s lead oral Ref-1 inhibitor, APX3330, currently in a Phase 2 trial (ZETA-1) for diabetic retinopathy, with data expected in 2022. The findings underscore APE1/Ref-1's significance in multiple pro-angiogenic pathways and indicate a potential therapeutic approach targeting this protein to improve treatment outcomes for retinal diseases.

Ocuphire Pharma (NASDAQ: OCUP) announced that its novel oral Ref-1 inhibitor, APX3330, will be showcased at the Ophthalmology Innovation Summit on October 7, 2021, and discussed in an abstract at ASRS's 39th Annual Meeting between October 8-12, 2021 in San Antonio, TX. Dr. Michael J. Allingham will present safety data from 11 clinical trials involving over 300 participants, supporting the ongoing ZETA-1 Phase 2b study evaluating APX3330 for diabetic retinal disease. This oral treatment aims to address diabetic retinopathy and diabetic macular edema, potentially targeting a $10 billion market.