During 12-week post-treatment period, nimacimab plus semaglutide blunts weight regain compared to semaglutide alone in subset analysisSAN DIEGO, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that it will present a late-breaking oral presentation at ObesityWeek 2025 on November 7, 2025, in Atlanta, Georgia. The presentation w ...

SAN DIEGO, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on advancing new therapeutic pathways for obesity and other metabolic health disorders, will host a conference call on Monday, November 10, 2025 at 1:30 p.m. PT/4:30 p.m. ET to discuss its third quarter 2025 financial results. The Company will issue its financial results and business update press release after the market closes on the same day. The live webcast of the ca ...

Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Skye Bioscience, Inc. regarding potential securities fraud or unlawful business practices by the company and its officers or directors [1] - On October 6, 2025, Skye announced that its Phase 2a study of nimacimab did not meet its primary endpoint of weight loss compared to placebo, leading to a significant drop in stock price [1] Company Overview - Skye Bioscience, Inc. is a publicly traded company on NASDAQ under the ticker SKYE [1] - The company is involved in the development of nimacimab, a peripherally-restricted CB1 inhibitor antibody [1] Financial Impact - Following the announcement of the study results, Skye's stock price fell by $2.85 per share, representing a 60% decrease, closing at $1.90 per share on October 6, 2025 [1]

Core Insights - Skye Bioscience (SKYE) shares plummeted 60% after failing to meet the primary weight loss goal in a mid-stage proof-of-concept study for its only pipeline candidate, nimacimab, aimed at treating obesity [1][5] - The phase IIa CBeyond study involved 136 adults and assessed the efficacy, safety, and pharmacokinetics of nimacimab [1][3] Study Details - Patients were randomized into four groups: nimacimab 200 mg, placebo, nimacimab with Novo Nordisk's Wegovy, and placebo with Wegovy, treated weekly for 26 weeks [2] - The nimacimab 200 mg monotherapy showed a body weight reduction of 1.52% compared to 0.26% with placebo at week 26, failing to achieve the primary weight loss goal [3] - The combination of nimacimab 200 mg and Wegovy resulted in a clinically meaningful weight loss of 13.2%, compared to 10.25% with Wegovy alone, with 100% of patients in the combination group achieving over 5% weight loss [7][8] Safety and Pharmacokinetics - Preliminary pharmacokinetic analysis indicated lower than expected exposure to nimacimab, suggesting the 200 mg dose may be suboptimal [4] - The safety profile of nimacimab was favorable, with no increase in gastrointestinal adverse events or treatment-related neuropsychiatric adverse events reported [9] Future Plans - Skye Bioscience is continuing the phase IIa CBeyond study for an additional 26-week extension, with results expected in early 2026 [10][11] - The company plans to test higher doses of nimacimab based on favorable preclinical data and observed dose-dependent weight loss [12] Market Context - Novo Nordisk's Wegovy is a leading GLP-1 therapy for obesity, generating $5.41 billion in sales during the first half of 2025, a 78% increase year-over-year [13] - Wegovy has received FDA accelerated approval for treating noncirrhotic metabolic dysfunction-associated steatohepatitis, with an oral formulation under review [14]

Company Overview - Skye Bioscience, trading under the symbol SKYE on NASDAQ, is focused on developing pharmaceutical products [1] - The company's market capitalization is approximately $58.88 million, indicating a moderate level of investor interest [4] Recent Developments - On October 6, 2025, Craig-Hallum downgraded SKYE from a Buy to a Hold rating, with the stock priced at $1.91, reflecting a cautious stance on its future performance [1][5] - Despite the Nasdaq Composite gaining over 150 points, SKYE shares experienced a sharp decline, currently priced at $1.90, which represents a significant decrease of 60% from previous levels [2] Stock Performance - The stock has fluctuated between a low of $1.77 and a high of $2.30 during the day, with a yearly high of $5.96 and a low of $1.14, indicating volatility and uncertainty in performance [3] - The trading volume for SKYE is 13.21 million shares, suggesting that investor caution may be influenced by recent performance and market conditions [4]

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]

Core Insights - Skye Biosciences is conducting a conference call to discuss the Phase IIa top line clinical trial results [1] Group 1 - The conference call is led by Bernie Hertel, Head of Investor Relations [1]

Core Points - Skye Biosciences is conducting a conference call to discuss the results of its Phase IIa clinical trial [1] - The call includes forward-looking statements regarding the company's development activities and timelines, which are subject to risks and uncertainties [2] - The CEO of Skye Biosciences, Punit Dhillon, is leading the discussion [3]

Market Overview - U.S. stocks showed mixed trading, with the Nasdaq Composite gaining over 150 points, while the Dow decreased by 0.16% to 46,684.03 and the S&P 500 rose by 0.40% to 6,742.80 [1] - Information technology shares increased by 0.9%, while real estate stocks fell by 0.8% [1] Company Highlights - Advanced Micro Devices (AMD) shares surged over 27% following a significant agreement with OpenAI to deploy up to 6 gigawatts of AMD Instinct GPU power for AI infrastructure [2] - The initial phase of the agreement includes a rollout of 1 gigawatt of AMD Instinct MI450 GPUs in the second half of 2026, with plans for further expansions across multiple generations of AMD's data center chips [2][3] - Spruce Biosciences, Inc. shares increased by 298% after receiving U.S. FDA breakthrough therapy designation for its enzyme replacement therapy for Sanfilippo Syndrome Type B [8] - OneMedNet Corporation shares rose by 130% after selecting Palantir Technologies to enhance its healthcare AI and real-world data analytics operations [8] - Critical Metals Corp shares gained 92% after entering a securities purchase agreement to raise $35 million through a private investment in public equity transaction [8] - Quantum Computing Inc shares dropped 11% following a $75 million oversubscribed private placement announcement [8] - Skye Bioscience, Inc. shares fell by 53% after its monotherapy arm did not meet primary endpoint in a study [8] - Dragonfly Energy Holdings Corp shares decreased by 22% after pricing a $25 million underwritten public offering [8] Commodity Market - Oil prices increased by 0.8% to $61.37, while gold rose by 1.7% to $3,976.90 [6] - Silver traded up 1.1% to $48.490, whereas copper fell by 1.2% to $5.0485 [6] International Markets - European shares were mixed, with the eurozone's STOXX 600 slipping 0.02% and Spain's IBEX 35 Index falling 0.10% [7] - Asian markets closed mixed, with Japan's Nikkei 225 gaining 4.75% and Hong Kong's Hang Seng index falling 0.67% [9]

Company Developments - Advanced Micro Devices (NASDAQ:AMD) shares surged over 27% following a landmark agreement with OpenAI to deploy up to 6 gigawatts of AMD Instinct GPU power for AI infrastructure [2][3] - The initial phase includes a rollout of 1 gigawatt of AMD Instinct MI450 GPUs in the second half of 2026, with plans for further expansions across multiple generations of AMD's data center chips [2] Market Movements - Spruce Biosciences, Inc. (NASDAQ:SPRB) shares increased by 316% after receiving U.S. FDA breakthrough therapy designation for its enzyme replacement therapy for Sanfilippo Syndrome Type B [9] - OneMedNet Corporation (NASDAQ:ONMD) shares surged 143% after selecting Palantir Technologies to enhance its healthcare AI and real-world data analytics operations [9] - Society Pass Incorporated (NASDAQ:SOPA) shares rose by 113% [9] - Lixiang Education Holding Co., Ltd. (NASDAQ:LXEH) shares fell 58% [9] - Skye Bioscience, Inc. (NASDAQ:SKYE) shares dropped 54% after failing to meet primary endpoint in a study [9] - Dragonfly Energy Holdings Corp. (NASDAQ:DFLI) shares decreased by 28% following a $25 million public offering announcement [9] Commodity Updates - Oil prices increased by 0.7% to $61.28, while gold rose by 1.8% to $3,977.90 [6] - Silver traded up 1.1% to $48.485, whereas copper fell by 1.4% to $5.0365 [6]