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Skye Bioscience (SKYE)

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Earnings summaries and quarterly performance for Skye Bioscience.

Recent press releases and 8-K filings for SKYE.

Skye Bioscience Reports Positive Nimacimab Phase 2a Extension Interim Study Results
SKYE
Product Launch
New Projects/Investments
Guidance Update
  • Skye Bioscience announced positive interim 52-week data from its Phase 2a CBeyond™ extension study, showing 22.3% total weight loss with nimacimab (200 mg dose) + semaglutide (2.4 mg) combination, with no plateau observed.
  • The combination therapy demonstrated reduced weight regain, with only 17.8% of lost weight regained during a 13-week off-therapy follow-up, compared to 37.3% for semaglutide alone.
  • A strong safety and tolerability profile was maintained, with no serious adverse events reported during the 52-week extension period.
  • Skye expects full topline data from the Phase 2a extension study in Q3 2026 and anticipates its current capital will fund operations into Q4 2026.
  • The company plans to advance nimacimab into a Phase 2b adaptive study to optimize combination therapy doses and evaluate its individual contributions with semaglutide and potentially tirzepatide.
5 days ago
Skye Bioscience Reports Positive Interim 52-Week Data for Nimacimab Combination Therapy
SKYE
New Projects/Investments
  • Skye Bioscience announced interim 52-week data from its Phase 2a CBeyond™ study, revealing that nimacimab combined with semaglutide achieved 22.3% total weight loss with no plateau observed.
  • The combination therapy demonstrated a durability advantage, as participants regained only 17.8% of lost weight during a 13-week off-therapy follow-up, compared to 37.3% for semaglutide alone.
  • The treatment maintained a strong safety and tolerability profile throughout the 52-week extension period, with no serious adverse events reported.
  • Full topline reporting for the Phase 2a extension data, including monotherapy and off-therapy follow-up, is anticipated in Q3 2026.
5 days ago
Skye Bioscience presents positive preclinical data for nimacimab in obesity at Keystone conference
SKYE
  • Skye Bioscience presented preclinical data for its CB1-inhibitor antibody, nimacimab, at Keystone's Obesity Therapeutics conference on January 29, 2026.
  • In Diet-Induced Obesity (DIO) mouse models, nimacimab demonstrated significant additive weight loss effects when combined with tirzepatide (39% and 46% weight loss respectively) and enhanced weight loss with semaglutide.
  • Nimacimab's weight loss was durable after treatment discontinuation, and it improved the weight rebound profile (regain blunted by ~80%) after tirzepatide discontinuation.
  • Skye is currently conducting a Phase 2a clinical trial for nimacimab in obesity, which includes assessing its combination with a GLP-1R agonist (Wegovy®).
Jan 29, 2026, 12:00 PM
Skye Biosciences Faces Federal Securities Class Action Investigation
SKYE
Legal Proceedings
Profit Warning
  • Faruqi & Faruqi, LLP is investigating potential claims against Skye Biosciences, Inc. (SKYE), following the filing of a federal securities class action against the Company.
  • The lawsuit alleges that Skye and its executives made false and/or misleading statements regarding the effectiveness and prospects of its drug, nimacimab.
  • This action stems from an October 6, 2025, announcement that nimacimab's monotherapy arm did not achieve its primary endpoint in a Phase 2a study, which led to Skye's stock price falling $2.85 per share, or 60%, to close at $1.90 per share on that day.
  • Investors who purchased securities between November 4, 2024, and October 3, 2025, are encouraged to contact the law firm, with a deadline of January 16, 2026, to seek the role of lead plaintiff.
Jan 14, 2026, 3:31 PM
Skye Bioscience Faces Class Action Lawsuit Over Nimacimab Efficacy
SKYE
Legal Proceedings
  • A class action lawsuit has been filed against Skye Bioscience, Inc. (NASDAQ: SKYE) by National plaintiffs’ law firm Berger Montague PC.
  • The lawsuit covers investors who purchased Skye securities during the Class Period of November 4, 2024, through October 3, 2025, with an investor deadline of January 16, 2026, to seek lead plaintiff status.
  • The complaint alleges that Skye failed to disclose that the efficacy of nimacimab, its lead product candidate, was lower than represented, overstating its clinical and commercial potential.
  • Following the disclosure on October 6, 2025, that nimacimab's Phase 2a study did not meet its primary endpoint, Skye's stock price declined $2.85 per share, or 60%, closing at $1.90.
Jan 14, 2026, 1:52 PM
Skye Bioscience Outlines 2026 Clinical Development Plan for Nimacimab
SKYE
Guidance Update
New Projects/Investments
  • Skye Bioscience provided its 2026 corporate outlook, focusing on advancing nimacimab, a peripherally restricted CB1-inhibiting antibody, for obesity and other metabolic health disorders.
  • Key clinical milestones for 2026 include the CBeyond Phase 2a 26-week extension data update and interim results expected in Q1 2026, and topline 52-week results expected in Q3 2026.
  • The company plans to finalize the Phase 2b (CBeyond 2) plan in Q1 2026 and targets a trial launch in Q3 2026 to evaluate multiple doses of nimacimab as monotherapy and in combination with incretin therapy.
  • In 2025, Phase 2a data demonstrated additive weight loss when nimacimab was combined with semaglutide, along with a favorable safety profile.
Jan 12, 2026, 12:00 PM
Faruqi & Faruqi Investigates Skye Biosciences Over Nimacimab Study Results
SKYE
Legal Proceedings
Profit Warning
  • Faruqi & Faruqi, LLP is investigating Skye Biosciences, Inc. (SKYE) for alleged federal securities law violations, specifically concerning false or misleading statements about the effectiveness and prospects of its drug, nimacimab.
  • The investigation was prompted by Skye's October 6, 2025 press release, which disclosed that nimacimab monotherapy did not achieve its primary endpoint in a Phase 2a study, leading to a 60% drop in Skye's stock price to $1.90 per share on that day.
  • Investors who purchased SKYE securities between November 4, 2024 and October 3, 2025 are encouraged to contact the firm, with a deadline of January 16, 2026 to seek the role of lead plaintiff in the federal securities class action.
Jan 9, 2026, 2:45 PM
Faruqi & Faruqi, LLP Investigates Skye Biosciences Following Stock Drop
SKYE
Legal Proceedings
Demand Weakening
Profit Warning
  • Faruqi & Faruqi, LLP is investigating potential federal securities law claims against Skye Biosciences, Inc. (SKYE).
  • The investigation concerns allegations that Skye made false and/or misleading statements regarding the effectiveness and prospects of its drug, nimacimab.
  • On October 6, 2025, Skye's stock price fell 60% to $1.90 per share after the company announced that nimacimab's monotherapy arm failed to achieve its primary endpoint of weight loss in a Phase 2a study.
  • Investors who acquired Skye securities between November 4, 2024, and October 3, 2025, and suffered losses, are encouraged to contact the firm, with a lead plaintiff deadline of January 16, 2026.
Jan 2, 2026, 3:07 PM
Faruqi & Faruqi Investigates Skye Bioscience Following Nimacimab Study Results
SKYE
Legal Proceedings
Demand Weakening
Profit Warning
  • Faruqi & Faruqi, LLP is investigating Skye Bioscience (NYSE: SKYE), and a federal securities class action has been filed alleging false or misleading statements regarding the effectiveness of its drug, nimacimab.
  • The investigation follows Skye's October 6, 2025 announcement that nimacimab's Phase 2a study did not achieve its primary endpoint of weight loss, which caused the company's stock price to fall $2.85 per share, or 60%, to close at $1.90 per share.
  • Investors who purchased Skye securities between November 4, 2024, and October 3, 2025, are encouraged to contact the firm, with the deadline to seek lead plaintiff status set for January 16, 2026.
Dec 26, 2025, 3:47 PM
Skye Bioscience Enters Collaboration and License Agreement with Halozyme
SKYE
New Projects/Investments
Product Launch
  • Skye Bioscience, Inc. entered into a Non-exclusive Collaboration and License Agreement with Halozyme, Inc. on December 18, 2025.
  • Under the agreement, Halozyme granted Skye Bioscience a non-exclusive license to its ENHANZE® drug delivery technology for the development of a subcutaneous formulation of nimacimab.
  • Skye Bioscience will make milestone payments tied to development, commercialization, and net sales achievements, and mid-single digit royalty payments based on worldwide net sales of the Product.
  • Halozyme will also be the exclusive supplier of clinical and commercial supplies of the API for its rHuPH20 bulk drug product.
Dec 23, 2025, 9:04 PM