The investigation concerns whether Skye and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. , /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Skye Bioscience, Inc. ("Skye" or the "Company") (NASDAQ: SKYE). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 SOURCE Pomerantz LLP ...

Key Takeaways SKYE stock plunged 60% after nimacimab missed the primary goal in its phase IIa obesity study.The nimacimab/Wegovy combo showed greater weight loss and no safety concerns through the initial 26 weeks.Enrollment for the study's 26-week extension phase is complete, with readout planned for early 2026.Shares of Skye Bioscience (SKYE) crashed 60% on Monday after the company failed to meet the key goal in a mid-stage proof-of-concept study of its only pipeline candidate, nimacimab, for obesity.The ...

Company Performance Summary - Horizon Space Acquisition I Corp. (HSPOR) experienced a price drop to $0.12, a decline of around 41.77%, indicating challenges in achieving its business objectives [2][7] - Lixiang Education Holding Co., Ltd. (LXEH) saw its price fall to $0.94, a dramatic decrease of 66.71%, although it has regained compliance with Nasdaq's market value requirements [3][7] - Skye Bioscience, Inc. (SKYE) experienced a decrease in its stock price to $1.89, a drop of 60.20%, following disappointing topline data from its Phase 2a clinical trial [4] - Stellar V Capital Corp. Warrant (SVCCW) saw its warrant price adjust to $0.34, reflecting a decrease of 35.85%, indicating uncertainty about its future acquisition prospects [5] Market Trends and Reactions - The companies mentioned span various industries, including healthcare, education, and financial services, and have experienced significant market adjustments [6] - The reasons behind these price movements could include broader market trends, industry-specific challenges, or company-related developments, with investors closely monitoring for signs of recovery [6]

Skye Bioscience Inc. (NASDAQ:SKYE) stock sank on Monday after the company released topline data from its 26-week Phase 2a CBeyond proof-of-concept study of nimacimab.The nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo (-1.52% vs. -0.26 for placebo, mITT).Preliminary pharmacokinetic analysis showed lower than expected drug exposure of nimacimab, supporting evaluation of higher dosing.Also Read: Skye Bioscience Advances Position In Competitive Obesity Market W ...

All drugs are investigational and subject to regulatory approval. Phase 2a Topline Clinical Data October 2025 Nasdaq: SKYE © 2025 Skye Bioscience, Inc. 1 Disclaimer and Important Information for Investors This presentation ("Presentation") has been prepared solely for general information purposes by or on behalf of Skye Bioscience, Inc. (together with its subsidiaries and affiliates, "Skye"). Any discussion of the potential use or expected success of our product candidates is subject to our product candidat ...

Nimacimab monotherapy did not meet its primary endpoint for weight loss; preliminary pharmacokinetic analysis showed lower than expected drug exposure, potentially indicating the need for higher dosing as a monotherapy.Clinically meaningful additional weight loss observed with combination of nimacimab, a peripheral CB1 inhibitor, and semaglutide compared to semaglutide alone.Nimacimab alone and in combination demonstrated a clean safety profile, with no added gastrointestinal adverse events and no nimacimab ...

On Friday, Skye Bioscience, Inc. SKYE announced the presentation of results from the Phase 1b study of nimacimab in subjects with metabolic-associated steatotic liver disease (MASLD) at the European Association for the Study of Diabetes (EASD) Annual Meeting.The study demonstrated that nimacimab was safe, well-tolerated, and exhibited predictable pharmacokinetics and low immunogenicity across multiple ascending dose cohorts.There were no serious adverse events, no discontinuations due to adverse events, and ...

Core Insights - Skye Bioscience, Inc. presented results from a Phase 1b study of nimacimab for metabolic-associated steatotic liver disease (MASLD) at the EASD Annual Meeting, highlighting its safety and tolerability profile [1][2][3] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][5] - The company aims to create first-in-class therapeutics by leveraging biologic targets with substantial human proof of mechanism [5] Study Results - The Phase 1b study demonstrated that nimacimab was safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events [2][3] - Gastrointestinal side effects were infrequent and mild, indicating a differentiated tolerability profile for nimacimab [2] - The study was previously conducted by Bird Rock Bio, Inc., which was acquired by Skye in 2023 [3] Future Focus - Skye's immediate focus is on the upcoming topline readout from the CBeyond™ Phase 2a obesity study, which is assessing nimacimab's efficacy [3][5] - The Phase 2a clinical trial is also evaluating the combination of nimacimab with a GLP-1R agonist (Wegovy®) [5]

Core Insights - Skye Bioscience, Inc. has completed the treatment phase for the last patient in its Phase 2a CBeyond™ clinical trial evaluating nimacimab for obesity, with topline data expected in late Q3/early Q4 of 2025 [1][3] Group 1: Clinical Trial Details - The CBeyond™ Phase 2a trial is a randomized, double-blind, placebo-controlled study focusing on weight loss, safety, tolerability, and metabolic biomarkers in adults with obesity and overweight [2] - The primary endpoint of the trial is to compare weight change from baseline to 26 weeks between nimacimab and placebo [2] - An exploratory arm of the trial is assessing the combination of semaglutide (Wegovy®) with nimacimab versus semaglutide with placebo [2] Group 2: Study Progress and Future Plans - Skye has completed enrollment for a 26-week extension of the Phase 2a trial, which aims to provide data on 52 weeks of treatment with nimacimab, either as monotherapy or in combination with semaglutide [5] - Patients who completed the initial 26 weeks were eligible for the extension, potentially leading to a total treatment duration of 52 weeks followed by a 12-week follow-up [5] - Data from the extension study is expected to be reported in Q1 2026 [5] Group 3: Company Strategy and Market Context - Skye is focused on developing new therapeutic pathways for metabolic health, particularly through the modulation of G-protein coupled receptors [6] - The company believes that peripheral CB1 inhibition via an antibody presents a promising alternative to existing GLP-1 weight loss drugs, which may not meet all patients' needs [4] - Skye aims to advance nimacimab as a potential new therapeutic option for obesity and overweight, addressing limitations of current treatments [4]

Core Insights - Skye Bioscience, Inc. will host a virtual KOL event on September 4, 2025, to discuss the upcoming topline results from the Phase 2a CBeyond™ trial of nimacimab, a first-in-class peripheral CB1 antibody for obesity [1][2] - The event aims to provide clarity on what constitutes success in the proof-of-concept study, focusing on safety, tolerability, and new preclinical insights related to nimacimab [2][7] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][8] - The company is conducting a Phase 2a clinical trial for nimacimab, which is designed to inhibit peripheral CB1 and is also assessing its combination with a GLP-1R agonist [8] KOL Event Highlights - The event will feature discussions with leading obesity experts, including Skye's CEO, Punit Dhillon, who will address the significance of safety and tolerability benchmarks in the obesity treatment landscape [2][7] - Key opinion leaders participating include Dr. Kevin Cannon, Dr. Sean Wharton, and Dr. Marcus Goncalves, who bring extensive experience in metabolic health and obesity research [3][4][6] Research Focus - The event will cover the mechanism and potential role of peripheral CB1 inhibition as a differentiated anti-obesity therapeutic pathway [7] - Newly generated preclinical data with nimacimab will be highlighted, contributing to the understanding of its potential advancement into Phase 2b development [2][7]