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. reports clinical-stage biotechnology developments focused on metabolic health disorders, obesity and overweight. The company's lead program, nimacimab, is a peripherally restricted monoclonal antibody inhibitor of the CB1 receptor being evaluated in the CBeyond Phase 2a program, including monotherapy and combination work with GLP-1 or other incretin-based therapies.
Recurring updates cover clinical data from CBeyond, higher-dose safety and pharmacokinetic work, regulatory feedback on follow-on trial design, manufacturing and formulation activities, scientific conference presentations, financial results and corporate outlooks. Skye also discusses its broader strategy of developing molecules that modulate G-protein-coupled receptors.
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.
Skye Bioscience (NASDAQ: SKYE) reported Q3 2025 results and clinical updates on nimacimab for obesity. Topline CBeyond Phase 2a data showed a 29% relative increase in weight loss for nimacimab plus semaglutide versus semaglutide alone at 26 weeks, an additional -3.2 cm waist circumference reduction, and lower rebound weight gain (18.1% vs. 49.8%) over 12 weeks post-treatment. The combination showed a clean neuropsychiatric safety profile and no increase in GI adverse events. A 26-week extension is fully enrolled (43 patients) with data expected in Q1 2026. Cash, cash equivalents and short-term investments were $35.3M as of Sept 30, 2025, funding operations into 2027. Q3 net loss was $12.8M.
Skye Bioscience (Nasdaq: SKYE) will present a late-breaking oral abstract at ObesityWeek 2025 on November 7, 2025 summarizing topline CBeyond™ Phase 2 data.
Key findings: nimacimab 200 mg weekly plus semaglutide blunted 12-week post-treatment weight regain (18.1% vs 49.8%), maintained significant weight loss vs placebo at 12 weeks post-treatment (p=0.006), and previously produced additional on‑treatment weight loss (-13.2% vs -10.25%, p=0.0372). Waist circumference improved by 3.17 cm more versus semaglutide alone (p=0.0492). Presentation: Dr. Louis Aronne, Nov 7, 2025, 9:15–9:30am EDT, GWCC-A411-A412.
Skye Bioscience (Nasdaq: SKYE) will report third quarter 2025 financial results and host a business update call on November 10, 2025 at 1:30 p.m. PT / 4:30 p.m. ET.
The company will issue its earnings press release and financial tables after market close on November 10, 2025. A live webcast and investor presentation will be available on the Skye Investor Relations website, with a replay posted after the call.
Skye will also present at the Stifel 2025 Healthcare Conference in New York on November 13, 2025 from 4:40–5:10 PM and will be available for one‑on‑one meetings.
Skye Bioscience (NASDAQ: SKYE) reported topline 26‑week Phase 2a CBeyond™ results for nimacimab. Monotherapy at 200 mg did not meet the primary endpoint (least‑squares mean -1.52% vs -0.26% placebo, p=0.2699) and showed lower‑than‑expected exposure on preliminary PK analysis, supporting evaluation of higher dosing. The nimacimab 200 mg + semaglutide arm showed additional weight loss versus semaglutide alone (-13.2% vs -10.25%, p=0.0372) with no increase in GI or neuropsychiatric adverse events. Extension data expected Q1 2026; detailed 26‑week results to be presented at ObesityWeek in November.
Skye Bioscience (NASDAQ:SKYE) presented Phase 1b study results for nimacimab, their peripheral CB1-inhibiting antibody, at the EASD Annual Meeting. The study, conducted in subjects with metabolic-associated steatotic liver disease (MASLD), demonstrated favorable safety and tolerability profiles.
Key findings include no serious adverse events, no discontinuations due to adverse events, and notably, no neuropsychiatric safety signals. The drug showed predictable pharmacokinetics, low immunogenicity, and only mild, infrequent gastrointestinal side effects across multiple ascending dose cohorts.
The study, originally conducted by Bird Rock Bio (acquired by Skye in 2023), supports nimacimab's potential role in treating metabolic diseases, with the company awaiting topline results from their CBeyond™ Phase 2a obesity study.
Skye Bioscience (NASDAQ:SKYE) reported promising preclinical data for its CB1 inhibitor nimacimab in diet-induced obesity (DIO) mouse studies. The drug demonstrated superior weight loss efficacy compared to monlunabant and enhanced results when combined with tirzepatide, achieving over 40% weight loss.
Key findings show nimacimab's differentiation as a peripherally-restricted CB1 inhibitor with potential superior safety profile, ability to reduce post-treatment weight rebound by over 50%, and enhanced efficacy when combined with both low and high-dose tirzepatide. The company expects to report top-line Phase 2 CBeyond™ study data in late Q3/early Q4 2025.
Skye Bioscience (Nasdaq: SKYE) has announced the completion of the 26-week treatment phase in its Phase 2a CBeyond™ clinical trial evaluating nimacimab, a peripherally-restricted CB1 inhibitor antibody for obesity treatment. The study's primary endpoint will assess weight loss changes between nimacimab and placebo, with an exploratory arm examining the combination with semaglutide (Wegovy®).
The company has also completed enrollment for a 26-week extension study, which will provide data for a total treatment duration of 52 weeks, followed by a 13-week follow-up period. Topline data from the initial phase is expected in late Q3/early Q4 2025, while extension study results are anticipated in Q1 2026.