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.
Skye Bioscience, Inc. (Nasdaq: SKYE) generates news primarily through its clinical and corporate progress in metabolic health, with a focus on obesity and overweight. The company regularly issues press releases on its Phase 2a CBeyond™ trial of nimacimab, a peripherally restricted CB1-inhibiting monoclonal antibody, and on related clinical, preclinical, and corporate milestones.
Readers of the SKYE news page can expect updates on topline and extension data from the CBeyond Phase 2a study, including weight loss outcomes, body composition findings, and analyses of rebound weight gain after treatment discontinuation. Skye’s releases have highlighted the performance of nimacimab as a monotherapy and in combination with semaglutide, reporting clinically meaningful additional weight loss, changes in waist circumference, and observations about safety, gastrointestinal tolerability, and neuropsychiatric events.
The company also publishes news on preclinical diet-induced obesity models, where nimacimab has been evaluated alone and with incretin-based therapies such as tirzepatide. These announcements describe weight loss effects, post-treatment weight maintenance, and modulation of metabolic and inflammatory pathways in animal studies. In addition, Skye reports on Phase 1b data in metabolic-associated steatotic liver disease, conference presentations at scientific and medical meetings, and participation in healthcare and investor conferences.
Corporate and regulatory news items include financial results, business updates, and collaboration agreements, such as Skye’s non-exclusive global collaboration and license agreement with Halozyme Therapeutics to use ENHANZE drug delivery technology for higher-dose subcutaneous administration of nimacimab. For investors and observers tracking developments in obesity therapeutics and CB1 inhibition, the SKYE news feed offers a centralized view of Skye’s reported clinical data, preclinical research, partnering activity, and financial disclosures over time.
Skye Bioscience, Inc. (OTCQB: SKYE) announced the filing of its definitive proxy statement ahead of a special meeting on September 30, 2022. This meeting will address a proposed business combination with Emerald Health Therapeutics, Inc. Stockholders as of August 29, 2022, will receive voting materials via mail or email. CEO Punit Dhillon expressed gratitude for Emerald's support and emphasized the importance of stockholder voting to secure valuable resources for their business plan. The definitive proxy statement is available for viewing online.
Skye Bioscience (OTCQB: SKYE) announces that 87.07% of Emerald Health Therapeutics shareholders approved the proposed merger plan. The next step involves Skye seeking shareholder approval in an upcoming meeting. Regulatory approval for Skye's Phase 1 clinical study has been granted, with enrollment expected to complete by early 2023. The company plans to submit its Investigational New Drug application to the FDA by year-end 2022 for a Phase II study on SBI-100 targeting glaucoma, a condition affecting over 70 million people worldwide.
Skye Bioscience has selected NextPharma as its contract manufacturing organization for the Phase 2 clinical trial of its proprietary synthetic cannabinoid, SBI-100 Ophthalmic Emulsion, aimed at treating glaucoma. Following a successful pre-IND meeting with the FDA, Skye plans to file for a US IND by Q4 2022 and commence the Phase 2 study in H1 2023, with results expected by year-end 2023. The development of SBI-100 OE may provide a new class of medicine for glaucoma, enhancing therapeutic efficacy in lowering intraocular pressure.
Skye Bioscience (OTCQB: SKYE) announces a delay in the production of its Phase 1 clinical trial material for SBI-100 Ophthalmic Emulsion due to a recently resolved cyber-attack and planned CMO maintenance. Production is rescheduled for early September, with Phase 1 study enrollment now expected in Q4 2022 and preliminary data in Q1 2023. Despite this delay, the company is advancing its Phase 2 clinical development plan, with the FDA allowing nonclinical toxicology data for IND application, which is not contingent on Phase 1 results. Phase 2 data could be reported by year-end 2023.
Skye Bioscience (OTCQB: SKYE) has announced new research collaborations with the University of Eastern Piedmont (UPO) in Italy and the Spanish Research Council (CSIC) to develop a library of cannabinoid derivatives aimed at modulating the endocannabinoid system. These partnerships focus on creating up to 100 novel molecules in the first year, targeting ophthalmic disorders. Skye aims to leverage these collaborations to strengthen its Cannabinoid Pharmaceutical Innovation Program and advance its lead drug candidate, SBI-100 Ophthalmic Emulsion, for treating glaucoma.
Skye Bioscience (OTCQB: SKYE) has announced a definitive agreement to acquire Emerald Health Therapeutics (CSE: EMH; OTCQB: EMHTF) through a share-for-share transaction expected to close in Q3 2022. Skye anticipates that this acquisition will enhance its funding for a Phase 2 clinical study of its lead therapeutic, SBI-100 Ophthalmic Emulsion, targeting glaucoma, planned for Q4 2022. Current Skye shareholders will own approximately 54% of the combined company, while former Emerald shareholders will own about 46%. The transaction requires shareholder and court approval.
Skye Bioscience announced promising preclinical results for its glaucoma treatment SBI-100, demonstrating superior efficacy over the standard care in a study published in the International Journal of Pharmaceutics. Formulated as a nanoemulsion with Carbopol® 940, SBI-100 showed a greater and longer-lasting reduction in intraocular pressure (IOP) than both latanoprost and timolol. With a maximum drop of 4.5 mmHg at 60 minutes and sustained effects for at least 480 minutes, this new formulation is aimed at transitioning to human trials soon. CEO Punit Dhillon expressed optimism for its clinical potential.
Skye Bioscience (OTCQB: SKYE) is advancing its lead product, SBI-100 Ophthalmic Emulsion, aimed at treating glaucoma. The company has partnered with CMAX Clinical Research to conduct a Phase 1 study, focusing on safety and pharmacokinetics in healthy volunteers. The trial will occur in Adelaide, Australia, with data expected by Q4 2022. SBI-100 OE shows promising results in preclinical studies, highlighting its potential to effectively lower intraocular pressure, a significant factor in glaucoma progression.
Skye Bioscience (OTCQB: SKYE) has partnered with Novotech Health Holdings to conduct a Phase 1 clinical study for its SBI-100 drug candidate aimed at treating glaucoma. This collaboration is expected to facilitate timely and cost-effective execution of the trial in Australia. The Phase 1 study is scheduled to begin in Q2 2022, with results anticipated in the latter half of the year. SBI-100 is a synthetic cannabinoid derivative designed to lower intraocular pressure, showing promising preclinical results—superior to existing glaucoma treatments.
Skye Bioscience (OTCQB: SKYE) announced the completion of a GLP nonclinical toxicology study for its SBI-100 ophthalmic nanoemulsion, a potential treatment for glaucoma. The study assessed ocular toxicity in rabbits, finding no adverse effects or histological changes. This positive outcome allows Skye to submit a clinical trial application to the Human Research Ethics Committee in Australia, aiming to initiate Phase 1 clinical trials in Q2 2022. SBI-100 is designed to provide a safer, localized delivery of cannabinoid therapy to reduce intraocular pressure, mitigating the risk of vision loss.
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