OKYO Pharma (OKYO) Receives FDA Approval for Expanded Access of Urcosimod
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 23 2026
0mins
Should l Buy OKYO?
Source: NASDAQ.COM
- FDA Approval for Expanded Use: OKYO Pharma has received FDA authorization for expanded access to Urcosimod 0.05% for a single patient suffering from severe neuropathic corneal pain, addressing a significant gap in effective treatments in this area.
- Urgent Clinical Need: The request for expanded access was made for a patient with debilitating symptoms and no effective treatment options, highlighting the urgent need for therapies in neuropathic corneal pain, which could present new market opportunities for OKYO.
- Drug Mechanism Advantage: Urcosimod's dual mechanism targeting both inflammatory pathways and nerve-related pain signaling supports its evaluation in this patient population, potentially enhancing its clinical applicability and market acceptance.
- Future Research Plans: OKYO plans to initiate a 120-patient Phase 2b/3 multiple-dose study later this year to further validate Urcosimod's efficacy, which, if successful, will lay a solid foundation for the company's future growth.
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Analyst Views on OKYO
Wall Street analysts forecast OKYO stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.170
Low
5.00
Averages
6.00
High
7.00
Current: 2.170
Low
5.00
Averages
6.00
High
7.00
About OKYO
OKYO Pharma Limited is a United Kingdom-based clinical-stage biopharmaceutical company developing therapies for the treatment of dry eye disease (DED) and neuropathic corneal pain (NCP). The Company is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. Its research program focuses on a novel G Protein-Coupled Receptor (GPCR). The Company’s lead candidate, urcosimod, is a non-steroidal anti-inflammatory and non-opioid analgesic. Urcosimod consists of a 10-mer C-terminal Chemerin sequence, a linker (PEG-8), and Palmitic acid. It has completed a Phase II trial in patients with DED and NCP. The Company also plans to evaluate its potential in benefiting patients with ocular neuropathic pain, uveitis and allergic conjunctivitis. It is also evaluating OK-201, a bovine adrenal medulla (BAM), lipidated-peptide preclinical analogue candidate that is in the developmental stage.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
OKYO Pharma Prices Public Offering at $1.85 per Share
- Public Offering Pricing: OKYO Pharma Ltd has announced a public offering of 10.82 million shares priced at $1.85 each, with gross proceeds expected to be around $20 million, indicating the company's proactive approach to financing ahead of the offering's expected closure on February 17, 2026.
- Underwriter Selection: Piper Sandler & Co. has been appointed as the sole manager for the offering, reflecting the company's careful and professional selection of partners to ensure a smooth fundraising process.
- Stock Price Fluctuation: Following the announcement, OKYO's stock fell 7.83% in the after-hours market to $2.00, indicating a negative market reaction to the offering, which may impact investor confidence.
- Clinical Development Plans: The company intends to use the net proceeds primarily for clinical development of its product candidates and general corporate purposes, particularly focusing on treatments for neuropathic corneal pain, highlighting its commitment to R&D and potential for future growth.
See More
OKYO Pharma Announces Public Offering of Shares
- Offering Size: OKYO Pharma plans to publicly offer 10,815,000 ordinary shares priced at $1.85 each, aiming to raise approximately $20 million, which could increase to about $23 million if the underwriter exercises its additional purchase option.
- Use of Proceeds: The funds raised will primarily support clinical development, general corporate purposes, and working capital, aimed at bolstering the company's future R&D and operational needs, thereby enhancing its market competitiveness.
- Underwriter Option: The underwriter has a 30-day option to purchase an additional 1,622,250 shares at the public offering price, indicating potential demand for the stock and investor confidence.
- Closing Timeline: The offering is expected to close on or around February 17, 2026, pending customary closing conditions, reflecting the company's positive outlook on future growth.
See More
OKYO Pharma Prices Public Offering at $1.85 per Share
- Offering Size: OKYO Pharma announced the pricing of 10,815,000 ordinary shares at $1.85 each, aiming for gross proceeds of approximately $20 million, demonstrating the company's proactive capital raising capabilities in the market.
- Underwriter's Option: The underwriter has a 30-day option to purchase an additional 1,622,250 shares, which, if fully exercised, would increase total proceeds to about $23 million, thereby enhancing the company's financial strength.
- Use of Proceeds: The company intends to utilize the net proceeds primarily for clinical development, general corporate purposes, and working capital, indicating its strategic focus on future product development and market expansion.
- Underwriter Details: Piper Sandler & Co. is serving as the sole manager for the offering, which is expected to close around February 17, 2026, reflecting the company's reliance on professional financial institutions to ensure the offering's success.
See More
OKYO Pharma Transitions ATM Facility to Leerink Partners
- Change of Financing Agent: OKYO Pharma has transitioned its ATM equity offering facility to Leerink Partners LLC, replacing B. Riley Securities Inc., aiming to enhance capital market access and financial flexibility in the biopharmaceutical sector.
- Market Access: The new ATM program allows OKYO Pharma to opportunistically sell common shares directly into the market at prevailing prices, subject to market conditions and the company's discretion, thereby raising funds without disrupting the market.
- Support for Clinical Development: CFO Keeren Shah highlighted that Leerink Partners' deep expertise in biotech and proven track record in executing ATM programs will aid in advancing the company's pipeline, particularly the lead candidate urcosimod for neuropathic corneal pain.
- Commission Structure: Under the agreement, Leerink Partners will act as the exclusive sales agent and receive a commission of 3.0% of gross proceeds from any shares sold, further optimizing OKYO Pharma's capital utilization efficiency.
See More
OKYO Pharma to Present Urcosimod Data at ASCRS Meeting
- Key Conference Presentation: OKYO Pharma's lead candidate urcosimod has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery Annual Meeting, highlighting its potential in treating neuropathic corneal pain and likely attracting significant attention from ophthalmology experts.
- Clinical Trial Results: Urcosimod demonstrated significant pain reduction and improvements in corneal nerve health in a recently completed Phase 2 trial, providing robust clinical data that may enhance its acceptance and usage in the market.
- Future Research Plans: The company plans to initiate a 150-patient Phase 2b/3 multiple-dose study in the first half of 2026 to further validate urcosimod's efficacy, paving the way for commercialization and addressing the urgent market need for effective treatments.
- FDA Fast Track Designation: Urcosimod has received FDA fast track designation as the first IND drug for neuropathic corneal pain, showcasing its innovation in the treatment space and potential for significant commercial opportunities for the company.
See More
OKYO Pharma Achieves Successful FDA Meeting on Urcosimod
- FDA Meeting Outcomes: OKYO Pharma's Type C meeting with the FDA confirmed the clinical development plan for urcosimod in treating neuropathic corneal pain, with the FDA recognizing a ≥2-point improvement on the VAS scale as a meaningful treatment effect, indicating significant market potential for the drug.
- Statistical Guidance Support: The FDA provided guidance on the statistical analysis plan, emphasizing that if finalized before unmasking and results are strong, it could provide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting, thereby de-risking the clinical trial pathway.
- Study Design Endorsement: The FDA endorsed the study design, sample size, and powering assumptions for urcosimod, and agreed that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence, further enhancing the credibility of the clinical trial.
- Future Research Plans: OKYO plans to initiate a 120-patient Phase 2b/3 multiple-dose study in the first half of 2026, aiming to address the significant unmet medical need in neuropathic corneal pain treatment, thereby advancing the company's strategic development in the biopharmaceutical sector.
See More
OKYO Pharma Prices Public Offering at $1.85 per Share
- Public Offering Pricing: OKYO Pharma Ltd has announced a public offering of 10.82 million shares priced at $1.85 each, with gross proceeds expected to be around $20 million, indicating the company's proactive approach to financing ahead of the offering's expected closure on February 17, 2026.
- Underwriter Selection: Piper Sandler & Co. has been appointed as the sole manager for the offering, reflecting the company's careful and professional selection of partners to ensure a smooth fundraising process.
- Stock Price Fluctuation: Following the announcement, OKYO's stock fell 7.83% in the after-hours market to $2.00, indicating a negative market reaction to the offering, which may impact investor confidence.
- Clinical Development Plans: The company intends to use the net proceeds primarily for clinical development of its product candidates and general corporate purposes, particularly focusing on treatments for neuropathic corneal pain, highlighting its commitment to R&D and potential for future growth.
See More
OKYO Pharma Announces Public Offering of Shares
- Offering Size: OKYO Pharma plans to publicly offer 10,815,000 ordinary shares priced at $1.85 each, aiming to raise approximately $20 million, which could increase to about $23 million if the underwriter exercises its additional purchase option.
- Use of Proceeds: The funds raised will primarily support clinical development, general corporate purposes, and working capital, aimed at bolstering the company's future R&D and operational needs, thereby enhancing its market competitiveness.
- Underwriter Option: The underwriter has a 30-day option to purchase an additional 1,622,250 shares at the public offering price, indicating potential demand for the stock and investor confidence.
- Closing Timeline: The offering is expected to close on or around February 17, 2026, pending customary closing conditions, reflecting the company's positive outlook on future growth.
See More
OKYO Pharma Prices Public Offering at $1.85 per Share
- Offering Size: OKYO Pharma announced the pricing of 10,815,000 ordinary shares at $1.85 each, aiming for gross proceeds of approximately $20 million, demonstrating the company's proactive capital raising capabilities in the market.
- Underwriter's Option: The underwriter has a 30-day option to purchase an additional 1,622,250 shares, which, if fully exercised, would increase total proceeds to about $23 million, thereby enhancing the company's financial strength.
- Use of Proceeds: The company intends to utilize the net proceeds primarily for clinical development, general corporate purposes, and working capital, indicating its strategic focus on future product development and market expansion.
- Underwriter Details: Piper Sandler & Co. is serving as the sole manager for the offering, which is expected to close around February 17, 2026, reflecting the company's reliance on professional financial institutions to ensure the offering's success.
See More
OKYO Pharma Transitions ATM Facility to Leerink Partners
- Change of Financing Agent: OKYO Pharma has transitioned its ATM equity offering facility to Leerink Partners LLC, replacing B. Riley Securities Inc., aiming to enhance capital market access and financial flexibility in the biopharmaceutical sector.
- Market Access: The new ATM program allows OKYO Pharma to opportunistically sell common shares directly into the market at prevailing prices, subject to market conditions and the company's discretion, thereby raising funds without disrupting the market.
- Support for Clinical Development: CFO Keeren Shah highlighted that Leerink Partners' deep expertise in biotech and proven track record in executing ATM programs will aid in advancing the company's pipeline, particularly the lead candidate urcosimod for neuropathic corneal pain.
- Commission Structure: Under the agreement, Leerink Partners will act as the exclusive sales agent and receive a commission of 3.0% of gross proceeds from any shares sold, further optimizing OKYO Pharma's capital utilization efficiency.
See More
OKYO Pharma to Present Urcosimod Data at ASCRS Meeting
- Key Conference Presentation: OKYO Pharma's lead candidate urcosimod has been accepted for presentation at the 2026 American Society of Cataract and Refractive Surgery Annual Meeting, highlighting its potential in treating neuropathic corneal pain and likely attracting significant attention from ophthalmology experts.
- Clinical Trial Results: Urcosimod demonstrated significant pain reduction and improvements in corneal nerve health in a recently completed Phase 2 trial, providing robust clinical data that may enhance its acceptance and usage in the market.
- Future Research Plans: The company plans to initiate a 150-patient Phase 2b/3 multiple-dose study in the first half of 2026 to further validate urcosimod's efficacy, paving the way for commercialization and addressing the urgent market need for effective treatments.
- FDA Fast Track Designation: Urcosimod has received FDA fast track designation as the first IND drug for neuropathic corneal pain, showcasing its innovation in the treatment space and potential for significant commercial opportunities for the company.
See More
OKYO Pharma Achieves Successful FDA Meeting on Urcosimod
- FDA Meeting Outcomes: OKYO Pharma's Type C meeting with the FDA confirmed the clinical development plan for urcosimod in treating neuropathic corneal pain, with the FDA recognizing a ≥2-point improvement on the VAS scale as a meaningful treatment effect, indicating significant market potential for the drug.
- Statistical Guidance Support: The FDA provided guidance on the statistical analysis plan, emphasizing that if finalized before unmasking and results are strong, it could provide substantial evidence of effectiveness at a future End-of-Phase 2b/3 meeting, thereby de-risking the clinical trial pathway.
- Study Design Endorsement: The FDA endorsed the study design, sample size, and powering assumptions for urcosimod, and agreed that the Ocular Pain Assessment Survey is appropriate as supportive quality-of-life evidence, further enhancing the credibility of the clinical trial.
- Future Research Plans: OKYO plans to initiate a 120-patient Phase 2b/3 multiple-dose study in the first half of 2026, aiming to address the significant unmet medical need in neuropathic corneal pain treatment, thereby advancing the company's strategic development in the biopharmaceutical sector.
See More
