LONDON and NEW YORK, Oct. 29, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, and for inflammatory eye diseases, announced that Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma, will present at the 33rd Annual BIO-Europe partnering conference in Vienna, Austria. BIO-Europe, one of the largest and most imp ...

Core Insights - Several healthcare and biotech stocks experienced significant price movements on September 29, driven by clinical trial updates, regulatory progress, and strategic announcements Company Performance Highlights - Phio Pharmaceuticals Corp. (PHIO) saw an 8.9% increase in after-hours trading, rising from $2.36 to $2.57, following a 5.83% gain during the regular session, attributed to a positive safety committee recommendation for its PH-762 skin cancer trial [1][2] - Barinthus Biotherapeutics plc (BRNS) rose 8.11% in after-hours trading to $1.60 after closing at $1.48, with a notable 21.3% gain, driven by renewed interest in its immunotherapeutic pipeline [2][3] - Neogen Corp. (NEOG) jumped 5.59% in after-hours trading to $5.90, reversing a 1.41% decline earlier in the day, following announcements of its upcoming earnings release and a renewed sponsorship agreement [3][4] - OKYO Pharma Ltd. (OKYO) increased by 9% in after-hours trading to $2.18 after a decline of 8.26% during the regular session, due to renewed focus on its clinical-stage program for urcosimod [5] - Aurinia Pharmaceuticals Inc. (AUPH) rose 8.05% in after-hours trading to $11.95, despite a 15.83% drop earlier, reflecting heightened activity around its lupus nephritis treatment, LUPKYNIS, and a collaboration with Otsuka Pharmaceutical [6] - RAPT Therapeutics, Inc. (RAPT) climbed 4.43% in after-hours trading to $27.80, following the FDA's clearance of its IND application for RPT904, allowing it to proceed with a Phase 2b trial targeting food allergies [7][8]

Core Insights - OKYO Pharma Ltd has announced significant topline data from its Phase 2 trial of urcosimod for treating neuropathic corneal pain, a condition with no FDA-approved treatments [1][4][11] - The trial was randomized, placebo-controlled, and involved 48 patients, with confocal microscopy used to confirm the presence of neuropathic pain [1][8][10] - The study was halted early after 17 patients completed 12 weeks of treatment due to notable pain reduction in those receiving urcosimod topically [2][10] Company Overview - OKYO Pharma is pioneering the development of the first drug specifically targeting neuropathic corneal pain, which is described as severe nerve pain comparable to having a spinal cord injury in the eye [5][11] - The company has received fast track designation from the FDA, allowing for an accelerated development process towards drug approval [11][12] Clinical Trial Details - The Phase 2 trial commenced in October and was designed to ensure that participants had neuropathic pain rather than inflammatory pain [8][9] - The decision to stop the trial early was made to assess the drug's effectiveness sooner, with the aim of moving forward with discussions with the FDA based on the preliminary data [10][12][13] Future Steps - Following the positive data from the trial, the company plans to approach the FDA to discuss the next stages of development for urcosimod [11][12] - The urgency in halting the trial early reflects the company's commitment to addressing the needs of patients suffering from a condition with no current approved treatments [14]

Core Insights - OKYO Pharma Limited has received $1.9 million in non-dilutive funding to support the clinical development of urcosimod for treating neuropathic corneal pain (NCP), a condition with no FDA-approved therapies [1][2][3] Company Overview - OKYO Pharma is a clinical stage biopharmaceutical company focused on developing innovative therapies for neuropathic corneal pain and dry eye disease, with its shares traded on NASDAQ [6] - The company aims to discover and develop novel molecules specifically targeting neuropathic corneal pain and dry eye disease [6] Product Development - Urcosimod, the lead drug candidate, is a lipid conjugated chemerin peptide agonist designed to treat ocular diseases by producing anti-inflammatory and pain-reducing effects [5] - Urcosimod has shown statistical significance in multiple endpoints in a completed Phase 2 trial for dry eye disease and has just completed a Phase 2 trial for neuropathic corneal pain [5][6] Market Need - Neuropathic corneal pain is a severe and underdiagnosed condition characterized by debilitating pain and sensitivity, currently treated off-label with no FDA-approved options available [4][5]

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Core Viewpoint - OKYO Pharma Limited has received Fast Track designation from the FDA for urcosimod, aimed at treating neuropathic corneal pain (NCP), a condition currently lacking an FDA-approved therapy [1][4]. Company Overview - OKYO Pharma Limited is a clinical stage biopharmaceutical company focused on developing innovative therapies for neuropathic corneal pain and dry eye disease, with its shares traded on the NASDAQ Capital Market [8]. Product Development - Urcosimod, previously known as OK-101, is being developed to address NCP, characterized by severe eye pain due to nerve damage [1][3]. - The Phase 2 trial for urcosimod is a double-masked, randomized, 12-week placebo-controlled study involving patients with confirmed NCP [6]. FDA Fast Track Designation - The Fast Track designation is intended to expedite the development and review of therapies for serious conditions, providing benefits such as more frequent FDA meetings and eligibility for Accelerated Approval [2]. - This designation highlights the urgent medical need for effective treatments for NCP, which is currently managed through off-label therapies [5]. Mechanism of Action - Urcosimod is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, involved in the inflammatory response and pain management [7]. - The drug has demonstrated anti-inflammatory and pain-reducing effects in preclinical models, with a design aimed at enhancing its residence time in the ocular environment [7].

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive focuses on sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - OKYO Pharma Limited is accelerating the clinical development of urcosimod for treating neuropathic corneal pain (NCP) following the early closure of its Phase 2 trial, which involved 17 patients [1][2][4]. Group 1: Clinical Trial Details - The Phase 2 trial was conducted at Tufts Medical Center in Boston, MA, and was designed as a double-masked, randomized, 12-week placebo-controlled study [2][6][8]. - The trial was closed early to access masked data and plan for an expanded multicenter trial, as significant interest has been shown by potential patients [2][4]. - A total of 48 patients were initially planned for enrollment, with NCP confirmed via confocal microscopy [6]. Group 2: Drug Information - Urcosimod, previously known as OK-101, is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor, involved in the inflammatory response and pain [7]. - The drug has demonstrated favorable safety and tolerability in a previous Phase 2 trial involving 240 patients [4][7]. - Urcosimod has shown anti-inflammatory and pain-reducing effects in preclinical models and is designed to enhance its residence time in the ocular environment [7]. Group 3: Future Plans - The company plans to analyze the efficacy data from the 17 patients who completed the trial and aims to meet with the FDA to discuss further development [4][8]. - There is a strong interest from patients for continued compassionate use of urcosimod, which the company is seeking to arrange [3].

Core Insights - OKYO Pharma Limited is developing urcosimod for treating neuropathic corneal pain (NCP) and inflammatory dry eye disease (DED), with the latter being a multi-billion-dollar market [1][8] - Urcosimod has demonstrated stability for over two and a half years in single-use ampoules, which is crucial for FDA approval [1][6] - The company is currently conducting a Phase 2b clinical trial for urcosimod in NCP patients, involving 48 participants [3][7] Company Overview - OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on innovative therapies for NCP and DED, with shares traded on NASDAQ [8] - The company emphasizes the importance of chemistry, manufacturing, and controls (CMC) in drug approval processes, particularly regarding shelf stability [2] Clinical Development - The Phase 2b trial for urcosimod is a double-masked, randomized, placebo-controlled study, confirming NCP through confocal microscopy [3] - Urcosimod is administered as eye drops, and its stability and efficacy have been positively received in earlier trials for DED [2][5] Drug Characteristics - Urcosimod is a lipid-conjugated chemerin peptide agonist targeting the ChemR23 receptor, designed to provide long-lasting effects in treating dry eye disease and corneal neuropathic pain [5] - The drug has shown anti-inflammatory and pain-reducing activities in preclinical models, enhancing its potential for clinical use [5]