Workflow
urcosimod
icon
Search documents
OKYO Pharma to present urcosimod Phase 2 results at ASCRS 2026 annual meeting
Proactiveinvestors NA· 2026-01-30 17:16
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
OKYO Pharma Announces Acceptance of Urcosimod Phase 2 Study Results for Presentation at Prestigious ASCRS Annual Meeting
Globenewswire· 2026-01-30 16:30
LONDON and NEW YORK, Jan. 30, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announces that an abstract on its lead candidate, urcosimod (formerly OK-101), has been accepted for presentation at the prestigious 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. The accepted paper, titled "Evalua ...
OKYO Pharma Announces Successful Type C Meeting with the FDA
Globenewswire· 2026-01-28 12:40
Core Insights - OKYO Pharma Limited has successfully held a Type C meeting with the FDA regarding the Phase 2b/3 clinical trial of urcosimod for treating neuropathic corneal pain (NCP) [1][2] - The FDA's alignment on the clinical development program for urcosimod is seen as a significant step forward in addressing the unmet medical need for patients suffering from NCP [2][6] - Urcosimod has received the first IND to treat NCP and has been granted fast track designation by the FDA, with a 120-patient Phase 2b/3 study expected to begin in the first half of the year [2][7] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain and inflammatory eye diseases, with its shares traded on the Nasdaq Capital Market [7] - The company has recently completed a successful Phase 2 trial of urcosimod in NCP patients and is preparing for further clinical studies [7] Neuropathic Corneal Pain (NCP) - NCP is a chronic condition characterized by severe eye pain and sensitivity, often resulting from damage to corneal sensory nerves, with no FDA-approved therapies currently available [3] - Patients with NCP often rely on off-label treatments with limited success [3] Urcosimod Details - Urcosimod is a lipid-conjugated chemerin peptide agonist that has demonstrated anti-inflammatory and pain-reducing effects in preclinical models [4] - Positive data from a Phase 2 trial indicated significant pain reduction in NCP patients, supporting its potential as a treatment option [4] FDA Meeting Highlights - The FDA confirmed that the proposed primary endpoint of Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, with a ≥2-point improvement indicating a significant treatment effect [6] - The FDA provided guidance on statistical analysis and endorsed the study design, sample size, and powering assumptions, which de-risks the pathway to a pivotal trial [6]
FDA Approves Compassionate Use of Urcosimod (0.05%) for the Treatment of Neuropathic Corneal Pain
Globenewswire· 2026-01-23 12:00
LONDON and NEW YORK, Jan. 23, 2026 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (Nasdaq: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has authorized a single-patient expanded access (compassionate use) Investigational New Drug (IND) application submitted by Pedram Hamrah, MD, at the University of South Florida, for the us ...
OKYO Pharma Appoints Industry Veteran Robert J. Dempsey as Chief Executive Officer
Globenewswire· 2026-01-05 12:00
Core Viewpoint - OKYO Pharma Limited announces the appointment of Robert J. Dempsey as Chief Executive Officer, transitioning Gary S. Jacob, Ph.D. to Chief Development Officer, to ensure continuity and advance the company's strategic direction in developing therapies for neuropathic corneal pain and inflammatory eye diseases [1][3][4]. Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on innovative therapies for neuropathic corneal pain (NCP) and inflammatory eye diseases, with shares traded on NASDAQ [15]. - The company has recently completed a successful Phase 2 trial of its lead drug, urcosimod, in patients with NCP and is planning a larger multicenter trial set to begin in Q1 2026 [15]. Leadership Transition - Robert J. Dempsey brings over 20 years of global ophthalmology experience, including significant roles in drug development and commercialization, previously serving as Group Vice President and Head of Global Ophthalmology at Shire [2][5]. - Dempsey's experience includes leading the commercialization of Xiidra, a top-selling dry eye treatment, and he is expected to leverage this expertise to advance urcosimod [2][4][7]. - Gary S. Jacob, Ph.D. has been recognized for his leadership in shaping OKYO's clinical strategy and will continue to support the company as Chief Development Officer and Board member [4][13]. Product Focus - Urcosimod, the company's lead asset, is a lipid conjugated chemerin peptide agonist that has shown anti-inflammatory and pain-reducing effects in preclinical models [10]. - The drug has demonstrated statistical significance in multiple endpoints in a Phase 2 trial for dry eye disease and has recently shown positive data for pain reduction in NCP patients [14]. Market Context - Neuropathic corneal pain is a severe condition currently lacking FDA-approved therapies, with existing treatments providing limited success [9]. - The transition in leadership and the focus on advancing urcosimod position OKYO Pharma to address significant unmet needs in this market [3][4].
OKYO Pharma to Ring the Opening Bell at Nasdaq
Globenewswire· 2025-12-19 12:00
LONDON and NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company which is developing urcosimod to treat neuropathic corneal pain (NCP), an ocular condition associated with chronic and often severe nerve-related pain but without an FDA-approved therapy, announced that Executive Chairman and Founder, Gabriele Cerrone and the OKYO management team will ring the Opening Bell at the Nasdaq MarketSite in Times Square, New York today. The ceremony ...
OKYO Pharma Announces New Data Showing Favorable Corneal Nerve Outcomes in Phase 2 Study for Neuropathic Corneal Pain
Globenewswire· 2025-12-11 13:30
Patients treated with 0.05% urcosimod demonstrated directionally favorable improvements in nerve fiber count and fiber length, trends not observed in the placebo groupThese findings suggest that urcosimod may have a positive impact on corneal nerve health in patients with neuropathic corneal painCorneal nerve imaging data from the Phase 2 NCP trial were analyzed using in vivo confocal microscopy LONDON and NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage bioph ...
Nutex Health Soars 21% After Hours On Revenue Surge; Biotech Peers Join Tuesday Gainers
RTTNews· 2025-11-19 04:44
Core Insights - Several small-cap biotech and pharma companies experienced notable gains in after-hours trading, with Nutex Health being the most significant mover following its quarterly results [1] Company Summaries - **Nutex Health Inc. (NUTX)**: The company saw its stock surge by 20.97% to $120.00 after reporting a third-quarter net loss of $17.7 million, compared to a net loss of $0.4 million in the same period last year. However, total revenue increased significantly by 220.7% year-over-year to $244.0 million from $76.1 million [2] - **Bullfrog AI Holdings, Inc. (BFRG)**: The stock rose by 5.87% to $0.9798 in after-hours trading, likely due to investor positioning ahead of an upcoming technical presentation at the AI Drug Discovery & Development Summit 2025 [3] - **Clearside Biomedical, Inc. (CLSD)**: The company’s stock increased by 6.51% to $3.27 after reporting a narrower third-quarter net loss of $5.97 million compared to $7.69 million last year, although revenue fell sharply to $201 thousand from $1.04 million [4] - **Aytu BioPharma, Inc. (AYTU)**: The stock climbed 8.91% to $2.20, following a prior close of $2.02. The company reported a first-quarter net income of $2.0 million versus $1.5 million a year ago, with revenue of $13.9 million compared to $16.6 million in the prior year [5] - **Adicet Bio, Inc. (ACET)**: The stock added 5.21% to $0.6325, with a reported third-quarter net loss of $12.4 million, slightly wider than last year's $11.6 million. Revenue declined by 16% year-over-year to $6.8 million, but the company reiterated its 2025 revenue guidance [6] - **OKYO Pharma Limited (OKYO)**: The stock rose by 2.44% to $2.18. The CEO is scheduled to present at the Ophthalmology Innovation Summit XV, discussing the investigational drug candidate urcosimod, which has shown promising results in Phase 2 trials [7]
OKYO Pharma to Present at OIS XV in San Diego
Globenewswire· 2025-11-18 13:30
Core Insights - OKYO Pharma Limited is focused on developing urcosimod for treating neuropathic corneal pain (NCP), a condition with no FDA-approved therapy [1][3][4] - The company will present at the Ophthalmology Innovation Summit (OIS) XV, highlighting its commitment to addressing unmet medical needs in the ophthalmic field [1][2][4] Company Overview - OKYO Pharma Limited is a clinical stage biopharmaceutical company listed on NASDAQ, dedicated to innovative therapies for NCP and dry eye disease [7] - The company is advancing urcosimod through clinical trials, including a recent Phase 2 trial that demonstrated promising results [3][6][7] Product Details - Urcosimod is a lipidated peptide designed to treat NCP, showing anti-inflammatory and pain-relieving effects in previous trials [3][6] - The drug is currently being evaluated in a multi-center clinical trial involving 120 patients, following positive top-line results from an earlier Phase 2 trial [3][4] Industry Context - The Ophthalmology Innovation Summit (OIS) XV is a key event for stakeholders in the eye care field, focusing on advancements in ophthalmic innovation [2] - The summit provides a platform for networking and sharing insights among innovators, investors, and clinicians [2]
OKYO Pharma to Present at BIO-Europe 2025 in Vienna
Globenewswire· 2025-10-29 11:00
Core Insights - OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain and inflammatory eye diseases, with a lead investigational candidate, urcosimod [1][6]. Company Overview - OKYO Pharma is listed on NASDAQ and is dedicated to discovering and developing novel molecules for treating ocular diseases, particularly neuropathic corneal pain and dry eye disease [6]. - The company recently completed a Phase 2 clinical trial for urcosimod, which is currently being evaluated for its efficacy in treating neuropathic corneal pain [6]. Clinical Development - Urcosimod, a lipid conjugated chemerin peptide agonist, has demonstrated anti-inflammatory and pain-reducing effects in preclinical models and has shown statistical significance in multiple endpoints during a 240-patient Phase 2 trial for dry eye disease [5]. - A recent Phase 2 trial involving 17 patients with neuropathic corneal pain has just been completed, indicating progress in the clinical development of urcosimod [5][6]. Upcoming Events - The CEO of OKYO Pharma, Dr. Gary S. Jacob, will present at the 33rd Annual BIO-Europe partnering conference in Vienna, Austria, scheduled for November 3-5, 2025, where he will discuss the company's advancements and clinical milestones [2][3].