OCUP - Earnings announcements

Acquisition creates a leading, clinical-stage company focused on the development of gene therapy treatments for rare inherited retinal degenerations New OPGx-LCA5 Phase 1/2 6-month data demonstrate safety and visual improvement in early onset retinal degeneration Additional clinical data in LCA5 pediatric patients and BEST1 patients is expected in 2H 2025 LYNX-2 Phase 3 trial of Phentolamine Ophthalmic Solution 0.75% in patients with dim light disturbances remains on track for top-line data in Q1 2025 VEGA-3 Phase 3 trial of Phentolamine Ophthalmic Solution 0.75% in presbyopia remains on track for top-line data in H1 2025 Company will seek a strategic partner to continue development of

VEGA-3 Phase 3 Study of Phentolamine Ophthalmic Solution in Presbyopia is Recruiting Patients with Top-Line Data Expected in 2025 LYNX-2 Phase 3 Study of Phentolamine Ophthalmic Solution Continues Enrollment with Top-Line Data Expected in 2025 Preparatory Steps Towards Phase 2/3 with APX3330 in Diabetic Retinopathy are Ongoing Cash Position of $41.4 million Provides Runway Anticipated into mid-2025 FARMINGTON HILLS, Mich., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of patients with retinal and refractive e

FARMINGTON HILLS, Mich., May 10, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing small molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced financial results for the first quarter ended March 31, 2024, and provided a corporate update. "Ocuphire has made significant progress in 2024, with important developments for both APX3330 and RYZUMVI™," said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire. "We have been engaged in productive dialogue with the U.S. Food and Drug Administration (FDA) with respect to our submitted Special Protocol Assessmen

FARMINGTON HILLS, Mich., March 08, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. "Ocuphire had a successful 2023, with notable achievements on the regulatory and development fronts, paving the way for further progress in the year ahead," said George Magrath, M.D., M.B.A., M.S., CEO of Ocuphire. "Our strategic focus is on the advancement of our retina pipeline, and we are preparing

FARMINGTON HILLS, Mich., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the Company's CEO, George Magrath M.D., M.B.A., M.S., will deliver a presentation at the Ophthalmology Innovation Summit (OIS XIII), to take place in San Diego, CA on December 1-2, 2023. Dr. Magrath will also host a conference call for the investment community on Tuesday, December 5, 2023. During this call he will provide a strategic update, including the company's plans to advance APX3330 into re

Successful End-of-Phase 2 Meeting with FDA for Oral APX3330; Agreement on Phase 3 Registration Endpoint RYZUMVI™ Approved by FDA; Ocuphire Received $10 million Regulatory Milestone Payment VEGA-2 Phase 3 Presbyopia Trial Met Primary Endpoint; Viatris Expected to Continue Phase 3 Development in 1H 2024 George Magrath, M.D., M.B.A., M.S. Named as CEO; Conference Call Scheduled for December 5th, 2023, at 10 AM ET FARMINGTON HILLS, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, tod

End-of-Phase 2 Meeting with FDA Scheduled for Q4 2023 for Oral APX3330 in Diabetic Retinopathy (DR) Cash Balance of $40 Million Expected to Fund Operations into 2025 Nyxol RM PDUFA date September 28, 2023; Approval would trigger $10 million milestone payment to Ocuphire Common Share Purchase Agreement with Lincoln Park Capital Fund, LLC providing up to $50 million in committed financing over 30 months FARMINGTON HILLS, Mich., Aug. 11, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorder

End-of-Phase 2 Meeting with FDA Anticipated in 2H 2023 to Confirm Phase 3 Regulatory Path for Oral APX3330 in Diabetic Retinopathy (DR) PDUFA date for Nyxol First Indication in Reversal of Pharmacologically-Induced Mydriasis (RM) Set for September 28, 2023; Nyxol Development and Commercialization Funded by Viatris Cash Balance of $39 Million Expected to Fund Operations into 2025 FARMINGTON HILLS, Mich., May 15, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced financial results for

Financial Profile Improved Markedly with Global License Agreement to Develop and Commercialize Nyxol for All Three Indications with Cash Runway into 2025 PDUFA Date of September 28, 2023 Set for Nyxol® in its First Indication, Reversal of Pharmacologically-induced Mydriasis; $10 Million Milestone Linked to Approval Oral APX3330 Achieved Statistical Significance on a Potential Registration Endpoint for Diabetic Retinopathy in ZETA-1 Trial; End-of-Phase 2 FDA Meeting Planned FARMINGTON HILLS, Mich., March 30, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatm

Oral APX3330 Achieved Statistical Significance on a Key Pre-specified Secondary Endpoint of Preventing Clinically Meaningful Progression of Diabetic Retinopathy (DR) after 24 Weeks of Treatment Oral APX3330 Demonstrated Favorable Safety and Tolerability Allowing for a Potential Attractive Non-Invasive Option for Protection of Vision in Both Eyes in DR Patients Conference Call and Webcast Today at 4:30pm ET FARMINGTON HILLS, Mich., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today annou

Ocuphire to Receive $35 Million Upfront, Nyxol Development Funding and Additional Potential Milestone Payments plus Tiered Double-Digit Royalties Strengthened Financial Position Supports Operations and APX3330 Program into 2025 Conference Call Tomorrow November 8, 2022 at 8:30 AM ET FARMINGTON HILLS, Mich., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP) today announced it has concluded an exclusive license agreement with FamyGen Life Sciences, Inc. (Famy) for the development and commercialization of Nyxol across three indications in US, Europe, Japan, India, China and other global markets. In connection with its separately announced transaction with Famy, Viatris

NDA Submission for Nyxol for RM and Initiation of VEGA-2 on Track for Q4 2022 Topline Data from ZETA-1 Phase 2b Trial of Oral APX3330 Expected in Early 2023 FARMINGTON HILLS, Mich., Nov. 04, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, announces financial results for the third quarter ended September 30, 2022 and provides a corporate update. "During the third quarter, Ocuphire continued to execute elements of our strategic plan to bring innovative treatments to patients with highly prevalent refractive and d

Completed Final Clinical Trials and Pre-NDA FDA Meeting to Support Registration of Nyxol in Reversal of Mydriasis (RM), On Track for Late 2022 NDA Submission and Potential 2023 Approval Positive Results from Phase 3 LYNX-1 Trial of Nyxol in Night Vision Disturbances (NVD) Mark Sixth Positive Nyxol Clinical Data Readout Across Multiple Indications Data Expected in 2H 2022 from Phase 2b Trial of APX3330, a Potential First-in-Class Oral Treatment for Diabetic Retinopathy Plans to Initiate VEGA Phase 3 FDA Registration Program for Nyxol Alone and in Combination with Low-Dose Pilocarpine (LDP) in Presbyopia in 2H 2022 FARMINGTON HILLS, Mich., Aug. 12, 2022 (GLOBE NEWSWIRE) -- Ocup

Meets Primary Endpoint With 58% Of Nyxol treated Subjects Returning to Baseline Pupil Diameter at 90 Minutes Compared to 6% of Placebo Subjects (p<0.0001) MIRA-3 Confirms Prior MIRA-2 Phase 3 Registration Trial Showing Substantial Benefit in Accelerating Reversal of Mydriasis (RM) NDA Filing for Nyxol in RM Planned for Late 2022 Potential Launch as Only Dilation Reversal Drop in 2H 2023 Conference Call and Webcast Today at 8.30am ET FARMINGTON HILLS, Mich., March 29, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retina

Building Momentum with Completion of Patient Enrollment in 4 Late-Stage Trials Multiple Late-Stage Clinical Trial Data Catalysts in 2022:– Nyxol® MIRA-3 Phase 3 Results Expected End of 1Q 2022– MIRA-4 Pediatric, and LYNX-1 Phase 3 Results Expected to follow in 2Q 2022– ZETA-1 Phase 2 Diabetic Retinopathy Results Expected in 2H 2022 NDA Filing for Nyxol in Reversal of Mydriasis Planned for Late 2022 with Potential Launch as First Dilation Reversal Drop in 2H 2023 Plans to Initiate VEGA Phase 3 FDA Registration Trials for Nyxol Alone and in Combination with Low-Dose Pilocarpine (LDP) in Presbyopia in Mid-2022 FARMINGTON HILLS, Mich., March 24, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, In

On Track to Initiate Additional Phase 3 FDA Registration Trials for Nyxol® Eye Drops in Reversal of Mydriasis (RM) in 4Q21 and Presbyopia in 1H22 Three Clinical Trial Data Readouts Expected in Early 2022 for Nyxol in Night Vision Disturbance, RM, and RM for Pediatric Patients Planned NDA Submission for Nyxol in Reversal of Mydriasis Indication in Late 2022 More Publications Supporting Novel Transcription Factor (Ref-1) Inhibitor, APX3330, Targeting Both Neovascularization and Inflammation in Retinal Diseases Currently Recruiting for Phase 2 Trial Evaluating APX3330 for the Treatment of Diabetic Retinopathy with Data Expected in 2H22 FARMINGTON HILLS, Mich., Nov. 12, 2021 (GLOBE NEWSWI

Reported Positive Data in First Pivotal Phase 3 Trial for Nyxol Eye Drops with Plans to Advance Towards NDA Submission and Commercialization in Reversal of Mydriasis Indication Demonstrated Execution Capability with Four Phase 3 and 2 Clinical Trials Initiated and/or Completed in 1Q21 Second Candidate APX3330 Actively Enrolling Diabetic Retinopathy Patients has the Potential to be a Novel Oral Treatment Option with Anti-VEGF and Anti-Inflammatory Mechanisms FARMINGTON HILLS, Mich., May 07, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing

FARMINGTON HILLS, Mich., March 10, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced financial results for the full year 2020 and provided a corporate update. “2020 was a transformative year for Ocuphire, with significant achievements on clinical, corporate and financial fronts. We became a Nasdaq-listed company through our reverse merger with Rexahn Pharmaceuticals and raised just over $21 million concurrent with the merger,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “Despite the challenges of