Research analysts covering OKYO Pharma.
Recent press releases and 8-K filings for OKYO.
OKYO Pharma Limited Reports Interim Results for H1 2025 with Clinical Progress and CEO Appointment
OKYO
Earnings
CEO Change
New Projects/Investments
- OKYO Pharma Limited reported a total comprehensive loss of $3.0 million for the six months ended September 30, 2025, an improvement from a $3.2 million loss in the prior year period.
- The company's cash on hand increased to $4.2 million at September 30, 2025, up from $1.6 million at March 31, 2025.
- Key clinical advancements for urcosimod included FDA Fast Track Designation for neuropathic corneal pain (NCP) and strong topline results from its Phase 2 trial, where 75% of per-protocol patients achieved over 80% pain reduction.
- Post-period, Robert J. Dempsey was appointed CEO on January 5, 2026, and the company held a successful Type C meeting with the FDA on January 28, 2026, aligning on the Phase 2b/3 clinical trial design for urcosimod, which is planned to initiate in the first half of 2026.
8 days ago
OKYO Pharma Announces Acceptance of Urcosimod Phase 2 Study Results for ASCRS Annual Meeting
OKYO
New Projects/Investments
- OKYO Pharma Limited announced that an abstract on its lead candidate, urcosimod, has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
- The presentation will detail efficacy and safety data from the recently completed proof-of-concept Phase 2 study of urcosimod in patients with neuropathic corneal pain (NCP), highlighting positive efficacy signals such as meaningful pain reduction.
- Building on these results, OKYO Pharma plans to initiate a 150-patient Phase 2b/3 multiple-dose study of urcosimod for NCP in the first half of 2026.
- Urcosimod has already received the first Investigational New Drug (IND) to treat NCP and was awarded Fast Track designation by the FDA.
8 days ago
OKYO Pharma Announces Successful FDA Type C Meeting for Urcosimod
OKYO
New Projects/Investments
Guidance Update
- OKYO Pharma Ltd. announced a successful Type C meeting with the FDA on January 28, 2026, regarding its Phase 2b/3 clinical trial of urcosimod for neuropathic corneal pain (NCP).
- The FDA confirmed the Phase 2b/3 clinical design, including the primary endpoint, sample size, and development approach, and aligned on the Chemistry, Manufacturing and Controls (CMC) strategy, which de-risks the program.
- The company expects to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of 2026.
Jan 28, 2026, 12:40 PM
OKYO Pharma Announces Successful FDA Type C Meeting for Urcosimod
OKYO
New Projects/Investments
Guidance Update
- OKYO Pharma held a successful Type C meeting with the FDA regarding the Phase 2b/3 human clinical trial of urcosimod for neuropathic corneal pain (NCP).
- The FDA confirmed that the proposed primary endpoint, Visual Analogue Scale (VAS) pain reduction at Week 12, is clinically meaningful, with a ≥2-point improvement on the VAS scale representing a meaningful treatment effect.
- The Agency endorsed the proposed study design, sample size, and powering assumptions, and aligned on the Chemistry, Manufacturing and Controls (CMC) strategy with no material issues raised, which de-risks the pathway to a pivotal trial and supports potential registration.
- The company expects to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of 2026.
Jan 28, 2026, 12:40 PM
OKYO Pharma Announces FDA Authorization for Compassionate Use of Urcosimod
OKYO
New Projects/Investments
Product Launch
- The U.S. Food and Drug Administration (FDA) has authorized a single-patient expanded access (compassionate use) Investigational New Drug (IND) application for OKYO Pharma's urcosimod (0.05%) to treat a patient with severe neuropathic corneal pain (NCP).
- This authorization addresses a significant unmet medical need, as there are currently no FDA-approved treatments specifically for NCP.
- Urcosimod had previously received the first IND for NCP and fast track designation from the FDA.
- OKYO Pharma plans to initiate a 120-patient Phase 2b/3 multiple-dose study of urcosimod for NCP this year.
- The drug has shown positive results in a Phase 2 trial for NCP pain reduction and statistical significance in an earlier Phase 2 trial for dry eye disease.
Jan 23, 2026, 12:00 PM
OKYO Pharma Appoints Robert J. Dempsey as CEO
OKYO
CEO Change
Management Change
Hiring
- OKYO Pharma announced the appointment of Robert J. Dempsey as its new Chief Executive Officer, effective immediately, on January 5, 2026.
- Gary S. Jacob, Ph.D., will transition from CEO to Chief Development Officer and continue to serve on the Board of Directors.
- Mr. Dempsey brings over two decades of global ophthalmology experience, including drug development, commercialization, and strategic transactions.
- He previously served as Group Vice President and Head of Global Ophthalmology at Shire, where he led the divestiture of Xiidra® for $3.4 billion upfront and up to an additional $1.9 billion in potential milestone payments.
- This leadership change is intended to position the company for its next phase of growth, particularly in advancing its lead asset, urcosimod, for neuropathic corneal pain and other ocular inflammatory disorders.
Jan 5, 2026, 12:00 PM
OKYO Pharma Appoints Robert J. Dempsey as Chief Executive Officer
OKYO
CEO Change
Management Change
New Projects/Investments
- Robert J. Dempsey has been appointed as the new Chief Executive Officer of OKYO Pharma, effective immediately.
- Former CEO, Gary S. Jacob, Ph.D., will transition to Chief Development Officer and continue to serve on the Board of Directors.
- Mr. Dempsey brings over two decades of global ophthalmology experience, including leading the $3.4 billion upfront divestiture of Xiidra® and its successful launch.
- This leadership change aims to advance the company's lead asset, urcosimod, for neuropathic corneal pain and other ocular inflammatory disorders.
Jan 5, 2026, 12:00 PM
OKYO Pharma to Ring Nasdaq Opening Bell
OKYO
New Projects/Investments
- OKYO Pharma Ltd. announced that its Executive Chairman and Founder, Gabriele Cerrone, and the management team will ring the Opening Bell at the Nasdaq MarketSite in Times Square, New York on December 19, 2025.
- The ceremony celebrates the company's progress in developing innovative treatments, including its lead candidate urcosimod, which targets neuropathic corneal pain (NCP).
- Urcosimod recently achieved positive Phase 2 results for NCP, demonstrating favorable corneal nerve outcomes and pain reduction, addressing a significant unmet medical need as there are currently no FDA-approved therapies for this condition.
- OKYO Pharma plans to initiate a second, larger, multicenter trial of urcosimod in NCP patients in Q1 2026.
Dec 19, 2025, 12:00 PM
OKYO Pharma Rings Nasdaq Opening Bell
OKYO
New Projects/Investments
- OKYO Pharma's Executive Chairman and Founder, Gabriele Cerrone, and the management team will ring the Nasdaq Opening Bell on December 19, 2025, to celebrate the company's ongoing advancements.
- The event highlights the progress of urcosimod, OKYO's lead candidate for neuropathic corneal pain (NCP), an ocular condition for which there are currently no FDA-approved therapies.
- The company recently announced positive Phase 2 results for urcosimod in NCP, demonstrating favorable corneal nerve outcomes and pain reduction.
- OKYO Pharma is planning to initiate a second, larger multicenter trial of urcosimod in NCP patients in Q1 2026.
Dec 19, 2025, 12:00 PM
OKYO Pharma Executive Chairman Acquires Additional Shares
OKYO
New Projects/Investments
- OKYO Pharma's Executive Chairman, Gabriele Cerrone, through Panetta Partners Limited, acquired an additional 24,551 ordinary shares on NASDAQ.
- This acquisition increases his total holding to 10,516,297 shares.
- OKYO Pharma is a clinical-stage biopharmaceutical company developing urcosimod to treat neuropathic corneal pain (NCP) and dry eye disease.
- Urcosimod recently completed a Phase 2 trial for neuropathic corneal pain and previously showed statistical significance in a 240-patient Phase 2 trial for dry eye disease.
Dec 15, 2025, 1:30 PM
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more