Ocuphire Pharma, Inc. - OCUP STOCK NEWS

Ocuphire Pharma, a clinical-stage biopharmaceutical company, has set a PDUFA date of September 28, 2023 for its Nyxol® NDA aimed at treating Reversal of Pharmacologically-induced Mydriasis (RM). Approval would trigger a $10 million milestone payment from Viatris. The company also anticipates an End-of-Phase 2 FDA meeting for its oral APX3330 focused on diabetic retinopathy in 2023. As of March 31, 2023, Ocuphire reported a preliminary cash balance of $39 million, expected to fund operations until 2025. The company emphasizes that all development timelines remain unchanged, with multiple catalysts expected this year, including progress in the VEGA-2 Phase 3 trial for presbyopia.

Ocuphire Pharma has appointed Rick Rodgers as the Interim Chief Executive Officer, succeeding Mina Sooch, as part of their ongoing executive transition. The company is working with an executive search firm to find a permanent CEO. Rick's extensive experience in late-stage biopharmaceutical companies is expected to enhance Ocuphire's strategic execution, particularly in advancing APX3330 into Phase 3 for diabetic retinopathy and obtaining regulatory approvals for Nyxol across three indications. The NDA for Nyxol has a PDUFA date of September 28, 2023, and the company anticipates positive regulatory outcomes. Rick's prior roles include leadership positions at TESARO and Abraxis BioScience, contributing to Ocuphire's growth and innovation in ophthalmic therapies.

Ocuphire Pharma reported a significant financial improvement for the year ended December 31, 2022, with a net income of $17.9 million compared to a net loss of $56.7 million in 2021. The company's cash position is strong, with approximately $42.6 million available, projected to fund operations into 2025. Key developments include a $35 million licensing agreement with Viatris for Nyxol, with a PDUFA date set for September 28, 2023, for its first indication. Oral APX3330 has shown statistical significance in the ZETA-1 trial, with a planned End-of-Phase 2 meeting. Positive clinical milestones are anticipated in 2023.

Ocuphire Pharma (Nasdaq: OCUP) announced five presentations at the ARVO Annual Meeting from April 23-27, 2023, in New Orleans, LA. Results from the ZETA-1 Phase 2 Trial of APX3330 in diabetic retinopathy and the LYNX-1 Phase 3 Trial of Nyxol for dim light vision disturbance will be highlighted. Key findings include APX3330 achieving statistical significance in preventing the progression of diabetic retinopathy after 24 weeks of treatment. The New Drug Application (NDA) for Nyxol has a PDUFA date set for September 28, 2023. These developments may impact investor interest positively, particularly regarding APX3330's efficacy.

Ocuphire Pharma (Nasdaq: OCUP) presented topline data from its ZETA-1 Phase 2 trial for the oral drug candidate APX3330 targeting diabetic retinopathy. Results were shared at the Angiogenesis, Exudation, and Degeneration 2023 Meeting on February 11 and are scheduled for presentation at the Macula Society 46th Annual Meeting on February 17. Key findings showed that APX3330 met the pre-specified secondary endpoint of preventing clinically significant worsening of diabetic retinopathy after 24 weeks of treatment, with a favorable safety profile noted during the trial. The company aims to position APX3330 as an effective non-invasive treatment option.

Ocuphire Pharma (Nasdaq: OCUP) announced the acceptance of its New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution 0.75%) by the FDA, targeting pharmacologically-induced mydriasis. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023. If approved, Nyxol could be the first FDA-approved eye drop to reverse pupil dilation, addressing a significant patient need. The NDA is backed by promising results from the MIRA clinical trials involving over 600 subjects. Current market research indicates strong demand, with over 80% of patients likely to ask for a dilation reversal option.

Ocuphire Pharma (Nasdaq: OCUP) announced positive topline results from the ZETA-1 Phase 2 trial of oral APX3330 for treating diabetic retinopathy (DR). Although the primary endpoint was not met, significant secondary endpoint results showed that 0% of APX3330-treated patients experienced a 3-step worsening in diabetic retinopathy severity score (DRSS) compared to 16% in the placebo group (p=0.04). APX3330 demonstrated a favorable safety profile with no serious adverse events. With funding from a recent partnership, Ocuphire plans to advance towards a Phase 3 trial, targeting the first oral treatment option for DR patients.