Ocuphire Pharma, Inc. - OCUP STOCK NEWS

Ocuphire Pharma (NASDAQ: OCUP) reported positive results from the MIRA-4 pediatric trial for Nyxol, showing a favorable safety profile and effective reversal of pupil dilation in children aged 3-11. The trial involved 23 participants and demonstrated a 64% efficacy rate at 90 minutes, exceeding placebo. With no adverse events reported, Ocuphire plans to file a New Drug Application (NDA) in late 2022, targeting a launch in the second half of 2023 if approved. This positions Nyxol as a potential first-of-its-kind treatment for mydriasis.

Ocuphire Pharma has announced four poster presentations featuring data on their product candidates APX3330 and Nyxol at the upcoming ARVO Annual Meeting (May 1-4, 2022). The presentations will highlight the safety and efficacy data from various clinical trials, including the Phase 2b trial of APX3330 for diabetic retinopathy and multiple Phase 3 trials of Nyxol for reversal of mydriasis and presbyopia. The company anticipates reporting top-line results from the ZETA-1 trial in the latter half of 2022.

Ocuphire Pharma has announced the appointment of Jay Pepose, M.D., Ph.D. as its new Chief Medical Advisor. This follows the positive outcomes from the MIRA-3 Phase 3 trial on Nyxol, which addresses mydriasis, and the VEGA-1 Phase 2 trial focused on presbyopia, both set to be presented at the upcoming ASCRS Annual Meeting. The company anticipates significant milestones in 2022, including a potential NDA submission for Nyxol and advancements in its other programs, strengthening its position in the ophthalmic sector.

Ocuphire Pharma, Inc. (Nasdaq: OCUP) announced its participation in the Wet AMD & DME Drug Development Summit on April 6, 2022. CEO Mina Sooch will present on APX3330, a Phase 2b oral small molecule targeting diabetic eye disease. The summit includes discussions on treatment burdens and future therapies for retinal diseases. Ocuphire is developing Nyxol® eye drops and APX3330, aiming to address diabetic retinopathy and macular edema. Their pipeline includes completed clinical trials with positive results, advancing towards commercialization.

Ocuphire Pharma (Nasdaq: OCUP) announced positive topline results from its MIRA-3 Phase 3 trial for Nyxol, demonstrating significant efficacy in reversing mydriasis. The trial met its primary endpoint with 58% of Nyxol-treated subjects returning to baseline pupil diameter at 90 minutes versus only 6% for placebo (p<0.0001). Following this result, an NDA filing is planned for late 2022, aiming for a commercial launch in the second half of 2023. The safety profile was favorable, with mild adverse effects noted. Nyxol could become the first FDA-approved treatment for mydriasis reversal, addressing a significant market need.

Ocuphire Pharma reported significant progress in its late-stage clinical trials for Nyxol and APX3330, with four trials completed in early 2022. Key upcoming milestones include topline results from the MIRA-3 Phase 3 trial expected by the end of Q1 2022, with potential NDA filing for Nyxol's mydriasis reversal in late 2022. Financially, Ocuphire had $24.5 million in cash at year-end 2021, projecting operational funding into Q2 2023. The net loss for 2021 was $56.7 million, reflecting increased R&D expenses due to ongoing trials.

Ocuphire Pharma (Nasdaq: OCUP) has completed enrollment in the Phase 2b ZETA-1 trial, assessing APX3330 for diabetic retinopathy (DR), involving 103 patients across 25 U.S. sites. This marks a significant milestone as APX3330 may become the first oral therapy for DR, addressing over 7 million patients with limited options. The trial results are expected in the second half of 2022. APX3330 exhibits a dual mechanism against angiogenesis and inflammation, potentially enhancing patient compliance compared to existing anti-VEGF treatments.

On March 10, 2022, Ocuphire Pharma (Nasdaq: OCUP) announced that its CEO, Mina Sooch, will present a corporate overview at the Oppenheimer 32nd Annual Healthcare Conference on March 16, 2022, from 8:00-8:30 AM EDT. Ocuphire is focused on developing therapies for refractive and retinal disorders and has two main product candidates: Nyxol, for various eye conditions, and APX3330, aimed at retinal diseases. The company continues to explore partnerships for development and commercialization opportunities.

Ocuphire Pharma (NASDAQ: OCUP) has completed patient enrollment in the MIRA-4 trial, assessing the safety and efficacy of Nyxol eye drops to reverse pharmacologically-induced mydriasis in pediatric patients aged 3 to 11. This trial is part of a broader MIRA clinical program, which aims for FDA approval to extend Nyxol's use to children. The company anticipates submitting a New Drug Application for Nyxol for reversal of mydriasis in late 2022, targeting a market valued at around $500 million, and expects pivotal results from MIRA-3 by the end of Q1 2022.