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 (Nasdaq: SKYE) will present at the GLP-1-Based Therapeutics Summit in Boston, April 14–16, 2026.
The company’s presentation, titled "Maximizing Efficacy, Minimizing Risk by Leveraging Peripheral CB1 Antagonism in Combination with GLP-1 Agonists to Advance the Obesity Treatment Paradigm," will be delivered by President & CEO Punit Dhillon on April 16 at 1:30 pm.
Skye Bioscience (Nasdaq: SKYE) treated the first patient in Part C of the CBeyond Phase 2a expansion testing higher-dose nimacimab (400 mg IV and 600 mg IV weekly) versus placebo over 16 doses with a 12-week follow-up. Topline safety and PK data are expected in Q4 2026.
The study randomizes 8 participants per cohort in a 3:1 ratio, links IV doses to ~700 mg and ~1,000 mg SC equivalents, and requires a cohort safety review before enrolling the 600 mg group. The company received FDA Type C feedback and will use Part C data to inform Phase 2b dose selection.
Skye Bioscience (NASDAQ: SKYE) reported Q4 and full-year 2025 results and updated clinical progress for nimacimab. Key updates include initiation of a 400 mg and 600 mg IV Expansion Study, FDA Type C meeting minutes received, interim 22.3% 52-week weight loss with nimacimab+semaglutide, and cash of $25.7M supporting operations into Q4 2026.
Topline Expansion Study results are expected in Q4 2026 and Phase 2b protocol finalization is planned for Q4 2026.
Skye Bioscience (Nasdaq: SKYE) will report 2025 fourth-quarter and full-year financial results and provide a business update on March 10, 2026. A press release will be issued after market close, followed by a conference call at 1:30 p.m. PT / 4:30 p.m. ET.
Investors can access a live webcast, financial tables, and an investor presentation on Skye's Investor Relations website; a replay and transcript will be posted after the call.
Skye (Nasdaq: SKYE) reported interim 52-week data from the Phase 2a CBeyond extension showing 22.3% mean weight loss with nimacimab (200 mg dose) plus semaglutide (2.4 mg) and no plateau observed. The combination reduced weight regain during a 13-week off-therapy period to 17.8% versus 37.3% for semaglutide alone. Safety remained favorable with no serious adverse events or adverse events of special interest reported. The extension enrolled 19 combination-arm participants; seven completed the full 52-week combination treatment. Full topline extension reporting, including monotherapy and follow-up, is expected in Q3 2026.
Skye Bioscience (Nasdaq: SKYE) presented preclinical data on nimacimab, a peripherally-restricted CB1-inhibitor antibody, at the Keystone Obesity conference on January 29, 2026. Key DIO mouse-model findings: nimacimab added to tirzepatide produced 39% and 46% weight loss, effects were durable after discontinuation, rebound was blunted by ~80%, and weight loss was not driven primarily by caloric restriction. Nimacimab also enhanced semaglutide-induced weight loss, suggesting potential as a maintenance or combination therapy to support efficacy with lower incretin doses.
Skye Bioscience (Nasdaq: SKYE) will present a poster at the Keystone Obesity conference on Jan 28, 2026 addressing nimacimab, a peripherally‑restricted CB1‑inhibitor antibody, in diet induced obesity models.
Presentation covers nimacimab alone, combined with tirzepatide, durability after treatment stop, maintenance use post‑tirzepatide, and role of caloric restriction. Presenting author: Chris Twitty, PhD. Poster session 2, poster number 2020, at 7:30 PM.
Skye (Nasdaq: SKYE) provided its 2026 corporate outlook focused on advancing nimacimab, a peripherally restricted CB1‑inhibiting antibody for obesity and metabolic disorders. Key near‑term milestones include a CBeyond Phase 2a 26‑week extension interim update expected Q1 2026, topline 52‑week results (with a 13‑week off‑therapy follow‑up) expected Q3 2026, and a target to initiate an adaptive Phase 2b study in Q3 2026 after finalizing the plan and a Type C meeting in Q1 2026. 2025 data reportedly showed additive weight loss with semaglutide, favorable safety/tolerability, dose‑response insights, preclinical durability versus incretins, and manufacturing partnerships to enable higher‑dose subcutaneous delivery.
Skye Bioscience (NASDAQ: SKYE) licensed Halozyme's ENHANZE drug‑delivery technology in December 2025 to co‑formulate nimacimab for subcutaneous, higher‑dose delivery in obesity.
The non‑exclusive global collaboration supports evaluation of larger injection volumes and planned Phase 2b testing in obesity starting in mid‑2026, including assessment of nimacimab combined with a GLP‑1 receptor agonist. Financial terms include milestone payments from Skye and mid‑single‑digit royalties to Halozyme on net sales of nimacimab developed with ENHANZE for at least 10 years.
Skye Bioscience (NASDAQ: SKYE) will participate in three investor conferences in early December 2025, offering investor access via scheduled 1x1 meetings and two public fireside chats. Key events and dates include:
- Citi Global Healthcare Conference (Miami) — 1x1 meetings on Dec. 2, 2025
- Evercore Annual Healthcare Conference (Coral Gables) — Fireside chat on Dec. 3, 2025 at 12:55 pm ET plus 1x1 meetings
- Piper Sandler Annual Healthcare Conference (New York) — Fireside chat on Dec. 4, 2025 at 11:30 am ET plus 1x1 meetings
Available webcasts will be accessible on Skye's investor website.