Skye's 2026 Clinical Program Focuses on Nimacimab
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 12 2026
0mins
Should l Buy SKYE?
"In 2025 we generated our Phase 2a clinical data, deepened our understanding of nimacimab's exposure-response dynamics, and built the technical foundation required to test higher doses and prepare the framework for a potential subsequent Phase 2 trial with broader clinical endpoints," said Punit Dhillon, CEO. "In 2026, our focus and goals are straightforward: deliver additional clinical readouts from our CBeyond extension study, assess and select higher doses of nimacimab, and launch a Phase 2b study designed to evaluate multiple doses of nimacimab as a monotherapy and in combination with an incretin therapy. We believe emerging data across the obesity treatment landscape underscore the need for modalities complementary to incretin-based therapies," added Mr. Dhillon. "We believe peripheral CB1 inhibition offers a distinctive opportunity to help achieve incremental weight loss, improve treatment tolerability and sustainability, enhance post-treatment durability, as well as offer additional metabolic and inflammatory benefits." Skye's 2026 clinical program goals are designed to evaluate multiple higher doses of nimacimab, and (nitiate a Phase 2b study that supports combination development. Planned clinical milestones include: CBeyond Phase 2a 26-week extension data update and interim results expected in Q1 2026. CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026. Phase 2b plan will be finalized and aligned with regulators, including completion of a Type C meeting in Q1 2026, with initiation of the adaptive design Phase 2b clinical trial expected in Q3 2026.
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Analyst Views on SKYE
Wall Street analysts forecast SKYE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SKYE is 14.33 USD with a low forecast of 10.00 USD and a high forecast of 20.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
4 Buy
1 Hold
0 Sell
Strong Buy
Current: 0.819
Low
10.00
Averages
14.33
High
20.00
Current: 0.819
Low
10.00
Averages
14.33
High
20.00
About SKYE
Skye Bioscience, Inc. is a clinical-stage biotechnology company. The Company is focused on development of next-generation molecules that modulate G-protein coupled receptors to treat obesity, overweight, and related conditions. The Company’s lead candidate, nimacimab, is a peripherally restricted negative allosteric modulating antibody targeting cannabinoid receptor 1 (CB1). The Company is also focused on its Phase IIa clinical trial, CBeyond, for nimacimab. The CBeyond clinical trial includes approximately 136 patients, 16 clinical trial sites and a combination arm with a GLP-1 receptor agonist to assess differences in weight loss, body composition, and other attributes. The CB1 receptor is one of the receptors in the endocannabinoid system (ECS) and plays a significant role both in the central nervous system (CNS) and peripheral tissues. The Company's Phase II study in obesity for nimacimab, is a negative allosteric modulating antibody that peripherally inhibits CB1.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Skye Bioscience Reports Interim Data from Nimacimab Study
- Clinical Trial Progress: Skye Bioscience's Phase 2a CBeyond study for obesity shows significant results with nimacimab combined with GLP-1R agonist (Wegovy), achieving an average weight loss of 14.4% at 26 weeks and 22.3% at 52 weeks, indicating the therapy's potential in weight management.
- Safety Assessment: The extension study reported no serious adverse events for the nimacimab and semaglutide combination, demonstrating good tolerability and safety, which bolsters confidence for future clinical applications.
- Comparative Analysis: The combination therapy group lost 13.2% of weight at 26 weeks compared to 10.25% in the semaglutide-only control group, suggesting that the combination may offer more durable weight loss effects.
- Future Outlook: Topline data from the CBeyond Phase 2a extension is expected in Q3 2026, with analyst William Blair noting that supportive data could attract investor interest, despite a current stock price decline of 5.53%.
See More
Skye Bioscience Reports Positive Clinical Data from Nimacimab Study
- Clinical Trial Results: Skye Bioscience's CBeyond Phase 2a study shows that the combination of nimacimab and semaglutide achieved a significant 22.3% weight loss over 52 weeks, highlighting the therapy's efficacy and potential market competitiveness.
- Durability Advantage: During the 13-week off-therapy follow-up, the nimacimab plus semaglutide cohort regained only 17.8% of lost weight compared to 37.3% for semaglutide alone, indicating a superior durability advantage of the combination therapy.
- Safety Assessment: The combination therapy demonstrated good tolerability at tested doses during the extension study, with no serious adverse events reported, further enhancing the therapy's market appeal.
- Future Outlook: Skye anticipates that optimized dosing of nimacimab in future clinical trials could lead to even deeper weight loss, showcasing the company's long-term growth potential in the obesity treatment sector.
See More
Skye Bioscience to Present Nimacimab Efficacy Study at Keystone Conference
- Clinical Research Presentation: Skye Bioscience will present its study on the obesity-targeting antibody nimacimab at the Keystone conference on January 28, 2026, exploring its effects on weight loss at various doses, aiming to provide new insights for obesity treatment.
- Mechanism Exploration: The research will assess whether nimacimab can serve as a maintenance therapy after discontinuation of tirzepatide and whether its weight loss effects primarily rely on caloric restriction, thus providing crucial data support for clinical applications.
- Innovative Drug Characteristics: Nimacimab, as a peripherally-restricted monoclonal antibody, is designed to avoid central nervous system penetration, potentially reducing the neuropsychiatric side effects commonly associated with small-molecule antagonists, showcasing its unique advantages in obesity treatment.
- Clinical Trial Progress: Skye is currently conducting a Phase 2a clinical trial for nimacimab in combination with the GLP-1R agonist Wegovy®, which will provide empirical support for its market potential in the obesity sector.
See More
Skye Bioscience Faces Class Action for Securities Fraud, Investors Encouraged to Join
- Lawsuit Reminder: The Schall Law Firm alerts investors of a class action lawsuit against Skye Bioscience for violations of securities laws, concerning securities purchases from November 4, 2024, to October 3, 2025, with a deadline to contact by January 16, 2026, to participate in claims.
- False Statements: The complaint alleges that Skye's drug candidate nimacimab was less effective than claimed, with the company overstating its commercial and clinical prospects, resulting in investor losses when the truth emerged.
- Legal Process: The class action has not yet been certified, meaning investors are not represented by an attorney until certification occurs, and those who choose not to act will remain absent class members, potentially forfeiting their claims.
- Investor Rights: The Schall Law Firm specializes in securities class actions and encourages affected investors to reach out for free consultations to discuss their rights, aiming to assist in recovering losses and protecting their legal interests.
See More
Skye Bioscience Faces Class Action for Securities Fraud, Investors Encouraged to Claim
- Lawsuit Reminder: The DJS Law Group alerts investors of a class action lawsuit against Skye Bioscience, Inc. (NASDAQ:SKYE) for violations of securities laws during the trading period from November 4, 2024, to October 3, 2025, encouraging affected investors to contact the firm for potential claims.
- False Statements: The complaint alleges that Skye made false and misleading statements regarding its drug nimacimab, which failed to demonstrate the efficacy previously claimed, resulting in significant losses for investors during the class period.
- Claim Deadline: Investors should note that the deadline to participate in the claims is January 16, 2026, and appointment as lead plaintiff is not required to seek recovery of losses.
- Legal Service Advantage: DJS Law Group specializes in securities class actions and corporate governance litigation, focusing on enhancing investor returns through balanced counseling and aggressive advocacy, serving some of the largest hedge funds and alternative asset managers globally.
See More
Skye Bioscience, Inc. Class Action Reminder: Lead Plaintiff Deadline January 16, 2026
- Class Action Notice: Rosen Law Firm reminds investors who purchased Skye Bioscience securities between November 4, 2024, and October 3, 2025, that they must apply to be lead plaintiff by January 16, 2026, to participate in the class action and potentially receive compensation.
- Fee Arrangement: Investors participating in the lawsuit will not incur any upfront costs, as the law firm operates on a contingency fee basis, which reduces financial risk for investors and encourages broader participation.
- Case Background: The lawsuit alleges that Skye Bioscience made materially false and misleading statements during the class period, particularly regarding the effectiveness and commercial prospects of nimacimab, resulting in investor losses when the truth emerged.
- Law Firm's Strength: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, demonstrating its strength and experience in handling such cases.
See More
Skye Bioscience Reports Interim Data from Nimacimab Study
- Clinical Trial Progress: Skye Bioscience's Phase 2a CBeyond study for obesity shows significant results with nimacimab combined with GLP-1R agonist (Wegovy), achieving an average weight loss of 14.4% at 26 weeks and 22.3% at 52 weeks, indicating the therapy's potential in weight management.
- Safety Assessment: The extension study reported no serious adverse events for the nimacimab and semaglutide combination, demonstrating good tolerability and safety, which bolsters confidence for future clinical applications.
- Comparative Analysis: The combination therapy group lost 13.2% of weight at 26 weeks compared to 10.25% in the semaglutide-only control group, suggesting that the combination may offer more durable weight loss effects.
- Future Outlook: Topline data from the CBeyond Phase 2a extension is expected in Q3 2026, with analyst William Blair noting that supportive data could attract investor interest, despite a current stock price decline of 5.53%.
See More
Skye Bioscience Reports Positive Clinical Data from Nimacimab Study
- Clinical Trial Results: Skye Bioscience's CBeyond Phase 2a study shows that the combination of nimacimab and semaglutide achieved a significant 22.3% weight loss over 52 weeks, highlighting the therapy's efficacy and potential market competitiveness.
- Durability Advantage: During the 13-week off-therapy follow-up, the nimacimab plus semaglutide cohort regained only 17.8% of lost weight compared to 37.3% for semaglutide alone, indicating a superior durability advantage of the combination therapy.
- Safety Assessment: The combination therapy demonstrated good tolerability at tested doses during the extension study, with no serious adverse events reported, further enhancing the therapy's market appeal.
- Future Outlook: Skye anticipates that optimized dosing of nimacimab in future clinical trials could lead to even deeper weight loss, showcasing the company's long-term growth potential in the obesity treatment sector.
See More
Skye Bioscience to Present Nimacimab Efficacy Study at Keystone Conference
- Clinical Research Presentation: Skye Bioscience will present its study on the obesity-targeting antibody nimacimab at the Keystone conference on January 28, 2026, exploring its effects on weight loss at various doses, aiming to provide new insights for obesity treatment.
- Mechanism Exploration: The research will assess whether nimacimab can serve as a maintenance therapy after discontinuation of tirzepatide and whether its weight loss effects primarily rely on caloric restriction, thus providing crucial data support for clinical applications.
- Innovative Drug Characteristics: Nimacimab, as a peripherally-restricted monoclonal antibody, is designed to avoid central nervous system penetration, potentially reducing the neuropsychiatric side effects commonly associated with small-molecule antagonists, showcasing its unique advantages in obesity treatment.
- Clinical Trial Progress: Skye is currently conducting a Phase 2a clinical trial for nimacimab in combination with the GLP-1R agonist Wegovy®, which will provide empirical support for its market potential in the obesity sector.
See More
Skye Bioscience Faces Class Action for Securities Fraud, Investors Encouraged to Join
- Lawsuit Reminder: The Schall Law Firm alerts investors of a class action lawsuit against Skye Bioscience for violations of securities laws, concerning securities purchases from November 4, 2024, to October 3, 2025, with a deadline to contact by January 16, 2026, to participate in claims.
- False Statements: The complaint alleges that Skye's drug candidate nimacimab was less effective than claimed, with the company overstating its commercial and clinical prospects, resulting in investor losses when the truth emerged.
- Legal Process: The class action has not yet been certified, meaning investors are not represented by an attorney until certification occurs, and those who choose not to act will remain absent class members, potentially forfeiting their claims.
- Investor Rights: The Schall Law Firm specializes in securities class actions and encourages affected investors to reach out for free consultations to discuss their rights, aiming to assist in recovering losses and protecting their legal interests.
See More
Skye Bioscience Faces Class Action for Securities Fraud, Investors Encouraged to Claim
- Lawsuit Reminder: The DJS Law Group alerts investors of a class action lawsuit against Skye Bioscience, Inc. (NASDAQ:SKYE) for violations of securities laws during the trading period from November 4, 2024, to October 3, 2025, encouraging affected investors to contact the firm for potential claims.
- False Statements: The complaint alleges that Skye made false and misleading statements regarding its drug nimacimab, which failed to demonstrate the efficacy previously claimed, resulting in significant losses for investors during the class period.
- Claim Deadline: Investors should note that the deadline to participate in the claims is January 16, 2026, and appointment as lead plaintiff is not required to seek recovery of losses.
- Legal Service Advantage: DJS Law Group specializes in securities class actions and corporate governance litigation, focusing on enhancing investor returns through balanced counseling and aggressive advocacy, serving some of the largest hedge funds and alternative asset managers globally.
See More
Skye Bioscience, Inc. Class Action Reminder: Lead Plaintiff Deadline January 16, 2026
- Class Action Notice: Rosen Law Firm reminds investors who purchased Skye Bioscience securities between November 4, 2024, and October 3, 2025, that they must apply to be lead plaintiff by January 16, 2026, to participate in the class action and potentially receive compensation.
- Fee Arrangement: Investors participating in the lawsuit will not incur any upfront costs, as the law firm operates on a contingency fee basis, which reduces financial risk for investors and encourages broader participation.
- Case Background: The lawsuit alleges that Skye Bioscience made materially false and misleading statements during the class period, particularly regarding the effectiveness and commercial prospects of nimacimab, resulting in investor losses when the truth emerged.
- Law Firm's Strength: Rosen Law Firm is renowned for its successful track record in securities class actions, having recovered over $438 million for investors in 2019 alone, demonstrating its strength and experience in handling such cases.
See More
