Ocuphire Pharma, Inc. - OCUP STOCK NEWS

Ocuphire Pharma (Nasdaq: OCUP) has announced the all-stock acquisition of Opus Genetics, creating a leading clinical-stage company focused on gene therapy treatments for rare inherited retinal degenerations. The combined company will be renamed Opus Genetics, Inc. and trade under the ticker symbol IRD effective October 24, 2024.

Key highlights include:

• New OPGx-LCA5 Phase 1/2 6-month data showing visual improvement in 3 out of 3 patients
• LYNX-2 and VEGA-3 Phase 3 trials of Phentolamine Ophthalmic Solution 0.75% on track for top-line data in Q1 and H1 2025, respectively
• Seeking strategic partner for APX3330 development
• Projected cash runway extended into 2026
• Four major clinical milestones expected in 2025

Ocuphire Pharma (Nasdaq: OCUP) announced the publication of full results from two pivotal Phase 3 clinical trials (MIRA-2 and MIRA-3) evaluating RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) for treating pharmacologically-induced mydriasis in the journal Ophthalmology. The trials demonstrated that RYZUMVI™ rapidly and effectively reversed pupil dilation with a favorable safety profile.

Key findings include:

• Statistically significant greater percentage of subjects achieved mydriasis reversal at 90 minutes compared to placebo
• Effects observed as early as 60 minutes post-administration
• Fewer subjects had residual dilation at 24 hours post-dilation compared to placebo
• Most common adverse events were mild and transient

RYZUMVI™ is currently approved for mydriasis treatment and is being evaluated for presbyopia and dim light vision disturbances after keratorefractive surgery in ongoing Phase 3 trials.

Ocuphire Pharma (Nasdaq: OCUP) has initiated the VEGA-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% to treat presbyopia. The study involves 545 participants and aims to demonstrate a 15-letter improvement in near vision acuity. Top-line data is expected in the first half of 2025.

Additionally, the company's LYNX-2 Phase 3 trial, evaluating the same solution for visual disturbances after keratorefractive surgery, is ongoing with top-line data expected in Q1 2025. This trial, conducted under a Special Protocol Assessment with the FDA, targets a 3-line improvement in low-contrast vision under low light conditions.

Ocuphire Pharma (Nasdaq: OCUP) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. VEGA-3 Phase 3 study of phentolamine ophthalmic solution for presbyopia is recruiting patients, with top-line data expected in 2025.

2. LYNX-2 Phase 3 study for dim light disturbances continues enrollment, with top-line data expected in 2025.

3. Preparations for Phase 2/3 study of APX3330 in diabetic retinopathy are ongoing.

4. Cash position of $41.4 million, providing runway into mid-2025.

5. Q2 2024 revenue was $1.1 million, including a $19,000 royalty payment from RYZUMVI™ sales.

6. Net loss for Q2 2024 was $7.8 million or $(0.30) per share.

Ocuphire Pharma (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company, has announced its participation in two upcoming investor conferences. Dr. George Magrath, the company's CEO, will present at:

1. The Canaccord Genuity 44th Annual Growth Conference in Boston, MA on August 14, 2024 at 9:00 a.m. ET in a fireside chat format.

2. The H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on August 15, 2024 at 10:30 a.m. ET, delivering a presentation.

Ocuphire Pharma focuses on developing small-molecule therapies for retinal and refractive eye disorders. Company management will be available for one-on-one meetings during both conferences. Interested parties can contact their conference representative or email ir@ocuphire.com to arrange meetings.

Ocuphire Pharma announced its participation in two upcoming scientific meetings to present APX3330 as a treatment for diabetic retinopathy (DR).

CEO George Magrath will join an ARVO SIG panel on July 11 to discuss oral medications for retinal diseases. The panel will be available on ARVO's website after the event.

Additionally, a subset analysis from the ZETA-1 Phase 2 clinical trial will be presented at the ASRS 42nd Annual Scientific Meeting. The study assesses APX3330's efficacy in slowing DR progression.

Diabetic retinopathy, affecting about 10 million Americans, is a leading cause of blindness in adults. Ocuphire aims to address patient compliance and treatment burdens associated with injectable therapies through the oral administration of APX3330.

Ocuphire Pharma announced updates on APX3330, their lead candidate for diabetic retinopathy (DR), which will be presented at two upcoming retina meetings in June. APX3330 is an oral small-molecule inhibitor targeting non-proliferative diabetic retinopathy (NPDR), affecting 80% of DR patients.

Presentations will occur at the Clinical Trials at the Summit meeting on June 8 in Park City, Utah, and the Retinal Imaging Biomarkers & Endpoints Summit from June 25-27 in Boston. Key speakers include Dr. Veeral Sheth and Dr. Ashwath Jayagopal, who will discuss clinical data and novel endpoints for DR.

CEO George Magrath highlighted APX3330's potential to address multiple DR pathways and emphasized the importance of multimodal imaging for early intervention. Ocuphire is planning to initiate the ZETA-2 Phase 2/3 trial for NPDR in early 2025.

Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company, announced financial results for Q1 2024, highlighting progress with APX3330 and RYZUMVI™. The company is in dialogue with the FDA regarding APX3330 for diabetic retinopathy. RYZUMVI™, launched by partner Viatris, marks a significant milestone. Ocuphire also disclosed updates on APX3330 and Phentolamine Ophthalmic Solution. Financially, Ocuphire had $47.2 million in cash as of March 31, 2024, with positive revenue from collaborations and royalties but faced increased expenses.

Ocuphire Pharma presented clinical data on APX3330 at the ARVO 2024 Annual Meeting, highlighting the drug's efficacy in slowing the progression of diabetic retinopathy. The Phase 2 ZETA-1 trial showed a significant reduction in DR worsening in participants treated with APX3330 compared to placebo, with favorable safety and tolerability profiles. Ocuphire is optimistic about the potential of APX3330 as a treatment option for patients at risk of vision-threatening complications.