Ocuphire Pharma Inc Stock Price, News & Analysis

Ocuphire Pharma has submitted a New Drug Application (NDA) to the FDA for Nyxol (Phentolamine Ophthalmic Solution 0.75%) aimed at reversing drug-induced dilated eyes. The NDA supports positive Phase 3 data from over 600 subjects showing significant results in pupil size reduction. This milestone aligns with a global licensing agreement with FamyGen Life Sciences, which was recently acquired by Viatris. Ocuphire expects Nyxol to be a unique treatment option if approved, enhancing its market potential.

Ocuphire Pharma has signed an exclusive licensing deal with FamyGen Life Sciences for Nyxol, securing a $35 million upfront payment and development funding. The agreement covers three indications globally, improving Ocuphire's cash position through 2025. The company anticipates a $10 million milestone payment post-FDA approval for Nyxol's reversal of mydriasis indication in 2023. Ocuphire will also receive tiered double-digit royalties on worldwide net sales through 2040, enhancing its financial outlook.

Ocuphire Pharma (Nasdaq: OCUP) reported its third quarter results, announcing key developments in its pipeline. The company is on track to submit a New Drug Application (NDA) for Nyxol, aimed at reversing mydriasis, in Q4 2022. They also expect to provide topline data from the ZETA-1 Phase 2b trial of APX3330 for diabetic retinopathy in early 2023. As of September 30, 2022, Ocuphire had approximately $13.9 million in cash, sufficient to fund operations into Q4 2023. The net loss for Q3 2022 was $4.5 million, improving from $4.2 million in Q3 2021.

Ocuphire Pharma (Nasdaq: OCUP) has announced positive Phase 2 clinical study results for phentolamine mesylate eye drops (Nyxol) in patients with night vision disturbances (NVD). The study's findings, highlighting Nyxol's safety and efficacy, were published in BMC Ophthalmology. The results contributed to the design of the Phase 3 LYNX-1 trial, which met its primary and secondary endpoints. Additionally, Ocuphire has partnered with the American Society of Ophthalmic Administrators to enhance the role of ophthalmic administrators in product adoption.

Ocuphire Pharma (Nasdaq: OCUP) announced the acceptance of six posters featuring its products Nyxol^® and APX3330 at the American Academy of Optometry (AAOPT) 2022 Annual Meeting from October 26-29, 2022, in San Diego, CA. The posters include important findings from clinical trials such as the safety of Phentolamine Ophthalmic Solution and APX3330 for treating eye disorders. The team will present data on various trials, including MIRA Phase 3 and ZETA-1 Phase 2b, showcasing advancements in the treatment of mydriasis and diabetic retinopathy.

Ocuphire Pharma, Inc. (Nasdaq: OCUP) announced a presentation by CEO Mina Sooch at the MicroCap Rodeo Windy City Roundup 2022 Conference on October 12, 2022, at 2:30 PM CT. The conference will be held at Swissotel Chicago, where management will also hold one-on-one meetings with registered investors. Ocuphire is developing therapies for refractive and retinal eye disorders, with lead product candidate Nyxol eye drops undergoing trials for several indications, including reversal of pharmacologically-induced mydriasis. Visit their website for more info.

Ocuphire Pharma (Nasdaq: OCUP) will host a webinar on October 14, 2022, at 11 AM ET to discuss its lead drug candidate, APX3330, aimed at treating diabetic retinopathy (DR) and diabetic macular edema (DME). The event will feature insights from key opinion leaders and present topline results from the ZETA-1 Phase 2b trial expected later this year. APX3330, a first-in-class oral treatment, is currently undergoing evaluation for its efficacy and safety, with promising data emerging from previous studies.

On September 29, 2022, Ocuphire Pharma, a Nasdaq-listed ophthalmic biopharmaceutical company, announced the appointment of seven new Key Opinion Leaders to its Medical Advisory Board. This group brings extensive clinical experience vital for advancing late-stage product candidates Nyxol and APX3330 through clinical and regulatory milestones. Additionally, Ronil Patel was promoted to Vice President, Business Development and Market Strategy, leveraging his 15 years of industry experience. The moves are expected to enhance Ocuphire's strategic growth.

Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company, announces key presentations at upcoming ophthalmology events. CEO Mina Sooch will provide a company overview at the Ophthalmology Futures Forums European Forum on September 15, 2022, and present the Nyxol program at Eyecelerator@AAO on September 29, 2022. Bindu Manne, Head of Market Development, will join a leadership panel the same day. Additionally, clinical data for Nyxol will be showcased at the American Academy of Ophthalmology Annual Meeting from September 30 to October 3, 2022.