STOCK TITAN

Skye Bioscience - SKYE STOCK NEWS

Welcome to our dedicated page for Skye Bioscience news (Ticker: SKYE), a resource for investors and traders seeking the latest updates and insights on Skye Bioscience stock.

Company Overview

Skye Bioscience (SKYE) is a clinical-stage biopharmaceutical company based in San Diego, California, that is dedicated to unlocking the therapeutic potential of the endocannabinoid system. The company focuses on the modulation of cannabinoid receptor 1 (CB1) with an emphasis on metabolic, inflammatory, and fibrotic conditions. Utilizing advanced antibody technology, Skye is developing innovative treatments aimed at addressing unmet medical needs in diseases such as obesity, chronic inflammation, and neurodegenerative disorders.

Core Therapeutic Focus

Skye Bioscience designs its clinical assets around the selective modulation of CB1 receptors outside the central nervous system. This approach is aimed at delivering metabolic benefits by mitigating adverse neuropsychiatric effects commonly associated with central CB1 inhibition. Their lead candidate, nimacimab, is a first-in-class humanized monoclonal antibody that acts as a negative allosteric modulator, effectively inhibiting peripheral CB1 receptors. This mechanism is hypothesized to provide differentiated benefits in weight reduction and metabolic regulation while avoiding central nervous system complications.

Product Pipeline and Development Strategy

  • Nimacimab: A negative allosteric modulating antibody currently under clinical evaluation, designed to block peripheral CB1 receptors to address metabolic dysfunction, obesity, and related inflammatory diseases.
  • Ophthalmic Programs: Previously, Skye investigated a CB1 agonist for ocular conditions; however, the clinical data did not support further development, allowing the company to redirect its resources toward its metabolic portfolio.

Mechanism of Action and Clinical Differentiation

The company’s primary innovation lies in its ability to target CB1 receptors in the periphery, thereby avoiding the penetration into the central nervous system. This approach diminishes the risk of neuropsychiatric adverse events, a limitation observed in small-molecule CB1 inhibitors. By leveraging substantial human proof of mechanism and compelling preclinical data, Skye Bioscience positions nimacimab as a potential next-generation therapeutic that could offer sustainable weight loss and improved metabolic outcomes compared to existing treatments.

Market Position and Competitive Landscape

Skye Bioscience is distinguished by its rigorous research and development process and a strategic focus on diseases with significant unmet medical needs. In the competitive biopharmaceutical landscape, its specialization in peripheral CB1 inhibition and antibody-based therapeutics sets it apart from competitors that rely on small-molecule approaches. This scientific differentiation is instrumental in establishing credibility with both clinical investigators and specialist investors.

Research and Development Approach

Driven by a commitment to scientific rigor, Skye Bioscience continuously refines its clinical protocols and preclinical models. The company’s research methodology involves detailed pharmacodynamic and pharmacokinetic assessments, with a specific focus on the impact of CB1 modulation on metabolic pathways. Their robust clinical design, which compares monotherapy with combination therapies involving GLP-1 receptor agonists, underscores the depth of their strategic approach.

Expertise and Strategic Insights

Backed by specialist life science investors and supported by an experienced management team, Skye Bioscience demonstrates significant expertise in the fields of immunotherapy and metabolic health. The company’s research is characterized by a strong commitment to safety and efficacy, and its strategic decisions are based on a nuanced understanding of the endocannabinoid system and its role in metabolic regulation. By maintaining a focus on peripheral mechanisms, Skye Bioscience aims to deliver therapies that are both safe and clinically differentiated.

Conclusion

In summary, Skye Bioscience stands as a notable example of innovation in biopharmaceutical research, with its work centered on antibody-mediated modulation of CB1 receptors. The company’s comprehensive approach to clinical development and its focus on conditions such as obesity and inflammatory diseases underscore its commitment to addressing significant health challenges. For investors and industry observers, Skye Bioscience represents a well-researched, methodically developed model poised to contribute valuable insights into the future of metabolic health therapeutics.

Rhea-AI Summary
Skye Bioscience, Inc. (OTCQB: SKYE) and Tautomer Bioscience (Pty) Limited have announced an agreement granting Tautomer an exclusive license to develop and commercialize Skye's proprietary THC prodrug, SBI-100, as a novel suppository application for chronic intractable pain and other indications in South Africa and the rest of Africa. The agreement includes development milestones, sales milestones, and tiered double-digit royalties on net product sales. Tautomer will also purchase Skye shares in open market transactions. This partnership aims to address the unmet medical need for non-opioid alternatives for chronic pain in South Africa.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
59.55%
Tags
none
-
Rhea-AI Summary
Skye Bioscience, Inc. (SKYE) has treated the first patient in its Phase 2 clinical trial evaluating SBI-100 Ophthalmic Emulsion’s ability to lower intraocular pressure, safety, and relevant biomarkers in patients with primary open-angle glaucoma or ocular hypertension. The Phase 2 study will compare two concentrations of SBI-100 OE vs. placebo, dosing twice a day for 14 days, with analysis of IOP data from 50% of patients enrolled to be performed in Q1 2024.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
-
Rhea-AI Summary
Skye Bioscience, Inc. (SKYE) to present its glaucoma program at two ophthalmology-focused conferences, showcasing SBI-100 Ophthalmic Emulsion, a first-in-class CB1 agonist. The company will introduce recent Phase 1 data and discuss details of its Phase 2a clinical study. Executives will be available for 1x1 meetings at the BTIG 3rd Annual Ophthalmology Day and OIS XIII Ophthalmology Innovation Summit.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-4.9%
Tags
conferences
Rhea-AI Summary
Skye Bioscience reports successful results from Phase 1 trial of SBI-100 OE, an ophthalmic drug targeting glaucoma
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-23.24%
Tags
-
Rhea-AI Summary
Skye Bioscience, Inc. announces 1-for-250 reverse stock split effective September 8th. Total issued and outstanding shares will be approximately 12,312,551. No fractional shares will be issued. Stockholders' ownership interest and voting power remain virtually unchanged.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
12.5%
Tags
none
-
Rhea-AI Summary
Skye Bioscience to present company overview at H.C. Wainwright 25th 3rd Annual Global Investment Conference
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
conferences
Rhea-AI Summary
Skye Bioscience expands resources and technologies with acquisition of Bird Rock Bio, raising $17M in new capital. Plans to advance Phase 2a glaucoma clinical trial with nimacimab and expects Phase 1 results for SBI-100 Ophthalmic Emulsion by end of Q3 2023. Skye's cash and cash equivalents expected to fund operations into 2024. Goal to uplist to a national stock exchange with proposed reverse stock split.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-18.75%
Tags
-
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-5.88%
Tags
conferences
-
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
Rhea-AI Summary
Skye Bioscience announces completion of production of placebo and SBI-100 Ophthalmic Emulsion for its Phase 2a study of glaucoma and ocular hypertension. The study will primarily focus on the efficacy of a synthetic pro-drug in human subjects targeting the CB1 receptor to reduce intraocular pressure. Additional steps are required before the study can begin.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
9.09%
Tags

FAQ

What is the current stock price of Skye Bioscience (SKYE)?

The current stock price of Skye Bioscience (SKYE) is $1.3 as of April 4, 2025.

What is the market cap of Skye Bioscience (SKYE)?

The market cap of Skye Bioscience (SKYE) is approximately 38.7M.

What is the core focus of Skye Bioscience?

Skye Bioscience is dedicated to developing innovative therapies that modulate the endocannabinoid system, specifically through targeted peripheral CB1 inhibition, to address metabolic, inflammatory, and fibrotic diseases.

How does nimacimab work?

Nimacimab is a negative allosteric modulating antibody designed to inhibit peripheral CB1 receptors, potentially offering metabolic benefits and aiding in weight reduction without the central nervous system risks associated with small-molecule inhibitors.

What therapeutic areas does the company target?

The company focuses on metabolic disorders, particularly obesity, as well as related inflammatory conditions, fibrosis, and certain neurodegenerative diseases.

How is Skye Bioscience differentiating itself in the biotech industry?

Skye Bioscience leverages advanced antibody technology and a specialized focus on peripheral CB1 receptor modulation, which sets it apart from competitors relying on small-molecule approaches and addresses significant unmet medical needs.

What are the key elements of Skye Bioscience’s development strategy?

The company employs a rigorous clinical trial design, robust preclinical models, and strategic resource allocation to refine its therapeutic candidates, ensuring safety, efficacy, and meaningful differentiation in the metabolic health space.

How does Skye Bioscience ensure a strong safety profile for its treatments?

By focusing on peripheral rather than central CB1 inhibition, Skye Bioscience minimizes the risk of neuropsychiatric side effects, an approach supported by both preclinical and early clinical data.
Skye Bioscience

OTC:SKYE

SKYE Rankings

SKYE Stock Data

38.72M
30.58M
1.32%
84.23%
7.14%
Biotechnology
Pharmaceutical Preparations
Link
United States
SAN DIEGO