Welcome to our dedicated page for Ocuphire Pharma news (Ticker: OCUP), a resource for investors and traders seeking the latest updates and insights on Ocuphire Pharma stock.
Ocuphire Pharma Inc (OCUP) is a clinical-stage biopharmaceutical company pioneering novel therapies for retinal and refractive eye disorders. This page serves as the definitive source for official news, press releases, and milestone updates related to OCUP's clinical developments and corporate strategy.
Investors and industry observers will find timely updates on regulatory submissions, clinical trial data, and strategic partnerships. Our curated collection includes announcements about pipeline advancements in diabetic retinopathy treatments, presbyopia solutions, and other ocular therapies under development.
Key content categories include progress reports on small-molecule drug candidates, collaboration updates with industry partners, and financial disclosures. All materials are sourced directly from company filings and authorized communications to ensure accuracy.
Bookmark this page for streamlined access to OCUP's latest developments in ocular therapeutics. Check regularly for updates on clinical milestones that may impact the company's trajectory in the ophthalmic biopharma sector.
Ocuphire Pharma (Nasdaq: OCUP) announced on September 12, 2022, that the FDA has granted a waiver for the $3.1 million PDUFA fee associated with the 505(b)(2) New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution). The NDA submission for the reversal of mydriasis (RM) is scheduled for late 2022. The company is also ramping up pre-commercial activities and discussions with partners in anticipation of Nyxol's potential launch in 2023. Positive results from clinical trials for Nyxol have been reported, indicating its effectiveness for multiple eye disorders.
Ocuphire Pharma (Nasdaq: OCUP) announced the completion of the final patient visit in the Phase 2b ZETA-1 trial of APX3330, an oral treatment for diabetic retinopathy (DR). The trial, initiated in April 2021, enrolled 103 subjects and focused on evaluating APX3330's efficacy and safety. Top-line results are anticipated in 4Q 2022, showcasing APX3330's favorable safety and tolerability profile from interim results. This drug aims to address the needs of the more than 8 million diabetic patients in the U.S. with limited current treatment options.
Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company, will present a corporate overview at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. CEO Mina Sooch will lead the presentation, available on-demand starting September 12 at 7 AM EST. Ocuphire focuses on therapies for refractive and retinal eye disorders, with lead product candidate Nyxol® eye drops showing positive results in multiple clinical trials. The company also aims to expand its ophthalmic assets and strategic collaborations.
Ocuphire Pharma (Nasdaq: OCUP) announced successful completion of final clinical trials for Nyxol aimed at reversing mydriasis, with a New Drug Application (NDA) submission expected in late 2022 and potential approval in 2023. Positive results from the Phase 3 LYNX-1 trial for Night Vision Disturbances (NVD) mark the sixth successful Nyxol clinical readout. The upcoming Phase 2b trial results for APX3330, targeting diabetic retinopathy, are anticipated in late 2022. Financially, the company reported $17 million in cash and an improved net loss per share of ($0.25) for Q2 2022.
Ocuphire Pharma announced the issuance of U.S. Patent No. 11,400,077, extending patent protection for Nyxol until 2039. Nyxol aims to treat mydriasis and could become the only FDA-approved drug for its reversal, with a potential NDA filing planned for late 2022. Depending on approval, Nyxol could launch in the second half of 2023. The company's patent estate for Nyxol now includes nine issued U.S. patents and additional applications worldwide. This expansion enhances the commercial value of Nyxol, which addresses a significant market opportunity with over 100 million eye dilations annually in the U.S.
Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company, announced significant presentations at multiple industry events in July 2022. CEO Mina Sooch will present at the 11th Annual AECOS Summer Symposium, sharing insights on Nyxol and other treatments. A late-breaking paper on Nyxol’s Phase 3 trials will be presented at the ASRS meeting, alongside interim safety data for APX3330 in diabetic retinopathy. Ocuphire aims to advance innovations in ophthalmic therapies and continue engaging with leading medical professionals.
Ocuphire Pharma announced a new patent from the USPTO extending the coverage of its oral drug candidate, APX3330, through 2038. The patent focuses on treating inflammation and chronic pain related to diabetes. Additionally, a peer-reviewed study highlighted NFkB as a key target for APX3330, which is currently in a Phase 2b trial for diabetic retinopathy (DR). Topline results from this trial are expected in 2H 2022, and interim safety data have been favorable, showing promise for treating vision-threatening diabetic eye diseases.
Ocuphire Pharma (Nasdaq: OCUP) announced significant progress in its ZETA-1 Phase 2b trial for APX3330, a non-invasive oral therapy targeting diabetic retinopathy. Out of 103 participants, 70% have completed over 12 weeks of the study, which aims to assess safety and efficacy. Key results are expected in the second half of 2022. CEO Mina Sooch will also contribute to a virtual ophthalmology panel hosted by Cantor Fitzgerald on June 8, 2022, discussing updates on APX3330 and other treatments.
Ocuphire Pharma (Nasdaq: OCUP) reported positive topline results from the Phase 3 LYNX-1 trial of Nyxol for treating night vision disturbances (NVD). The trial met its FDA-agreed primary endpoint, with 13% of Nyxol-treated subjects improving vision significantly compared to 3% in the placebo group (p<0.05). Secondary endpoints also showed improvements at Day 15, with 21% of subjects achieving notable vision gains. Nyxol demonstrated a favorable safety profile with no serious adverse events reported. The results underline Nyxol's potential to address a significant unmet need in eye care.
Ocuphire Pharma (Nasdaq: OCUP) reported significant progress in the first quarter of 2022, highlighting five positive clinical data readouts and successful enrollment in four late-stage trials for Nyxol and APX3330. The company is on track for a New Drug Application (NDA) submission for Nyxol in late 2022, aiming for potential launch in 2H 2023. Financially, Ocuphire's cash and equivalents totaled approximately $19.2 million, sufficient to fund operations into Q2 2023, despite a net loss of $6.6 million for the quarter.
