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Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market
Globenewswire· 2026-01-28 13:30
Clinical studies designed to support FDA clearance and planned commercial launch into the world’s largest drug screening market Company anticipates full data analysis by the end of March 2026; data to be incorporated into FDA 510(k) submission package NEW YORK, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the commencement of its clinical s ...
MIRXES(02629) - 自愿性公告 - 於泰国的近期业务发展进程
2026-01-09 09:37
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或依 賴該等內容而引致的任何損失承擔任何責任。 Mirxes Holding Company Limited ( 於 開 曼 群 島 註 冊 成 立 的 有 限 責 任 公 司 ) (股份代號:2629) 自願性公告 於泰國的近期業務發展進程 本公告乃由Mirxes Holding Company Limited(「本公司」,連同其附屬公司統稱「本 集團」)自願刊發,旨在知會本公司股東及潛在投資者有關本集團的最新業務 發展。 與N HEALTH建立戰略夥伴關係 本公司董事(「董事」)會(「董事會」)宣佈,本公司已於2025年12月15日與N Health (「N Health」,為 一 家 醫 療 保 健 解 決 方 案 供 應 商 及 泰 國 最 大 醫 療 保 健 供 應 商 Bangkok Dusit Medical Services (BDMS) Group的成員公司)建立戰略夥伴關係(「戰 略夥伴關係」)。戰略夥伴關係旨在將先進的microRN ...
Intelligent Bio Solutions Announces $10.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-12-31 22:20
Core Viewpoint - Intelligent Bio Solutions Inc. has entered into a securities purchase agreement to raise approximately $10 million through a private placement of common stock and warrants, aimed at enhancing its working capital and general corporate purposes [1][2]. Group 1: Securities Offering - The company will issue 2,298,850 shares of common stock and associated Series K-1 and K-2 warrants, priced at $4.35 per share, with expected gross proceeds of around $10 million before expenses [1]. - The Series K-1 and K-2 warrants will have an exercise price of $4.10 per share and will be exercisable immediately upon issuance, with a term of five years [1]. - The closing of the private placement is anticipated on or about January 2, 2026, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized for working capital and general corporate purposes [2]. Group 3: Company Overview - Intelligent Bio Solutions Inc. specializes in medical technology, focusing on intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [5]. - The company's technology allows for quick sample collection and results in under ten minutes, targeting industries such as construction, manufacturing, and transport [5].
Intelligent Bio Solutions Inc. Announces Reverse Stock Split
Globenewswire· 2025-12-12 15:30
Core Viewpoint - Intelligent Bio Solutions Inc. will implement a 1-for-10 reverse stock split effective December 15, 2025, to enhance its stock price and maintain compliance with Nasdaq listing requirements [1][2]. Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on providing intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [4]. - The company aims to revolutionize portable testing via fingerprint sweat analysis, targeting industries such as construction, manufacturing, transport, and drug treatment organizations [4]. Reverse Stock Split Details - The reverse stock split will combine every 10 shares of common stock into one share, with no fractional shares issued; instead, stockholders will receive cash for any fractional shares [3]. - After the split, the par value of the common stock will remain at $0.01 per share, and the total number of authorized shares will stay at 100 million [3]. - Following the reverse split, approximately 959,533 shares of common stock will be issued and outstanding [3].
Here's Why Grail Soared, Again, in November
Yahoo Finance· 2025-12-02 09:54
Core Insights - Grail is a leader in the multi-cancer early detection (MCED) market, with its stock rising 20.1% in November following positive third-quarter results and an analyst day [1] Company Overview - Grail's Galleri test screens for over 50 types of cancer and is the first MCED available commercially, although it has not yet received FDA approval, which management aims to achieve by the first half of 2026 [2] - The company faces competition from larger firms like Exact Sciences, which has its own MCED product, CancerGuard [2] Strategic Goals - Grail aims to grow commercial sales of Galleri while reducing cash burn, with a reported 39% year-over-year growth in Galleri tests in Q3, generating $32.6 million in revenue [3] - Cash burn has decreased to $59 million from $71.8 million in the previous quarter and $105.2 million a year ago [3] Financial Position - Following a successful private placement, Grail has a cash position of $850 million with no long-term debt, providing significant resources ahead of potential FDA approval for Galleri [4] Market Dynamics - The recent acquisition of Exact Sciences by Abbott Labs for a substantial premium underscores the attractiveness of the MCED market, raising speculation about potential acquisitions, including Grail [5] - Grail's Galleri test offers significant benefits for early cancer detection, positioning the company as a strong candidate for acquisition by larger firms [6] Acquisition Potential - Larger companies are likely to acquire firms like Grail and Exact Sciences due to their resources and market presence, with Grail being viewed as a more attractive acquisition target compared to Exact Sciences, which already has an FDA-approved product [7]
TMO Stock May Rise Post New PCR Test in Collab With Coca-Cola Partner
ZACKS· 2025-11-20 13:51
Core Insights - Thermo Fisher Scientific (TMO) has launched the Thermo Scientific SureTect Beverage Spoilage Multiplex qPCR assay, marking an industry-first all-in-one quantitative PCR-based test developed in collaboration with Coca-Cola Europacific Partners [1][2] Product Development - The new assay is part of the Thermo Scientific SureTect PCR System and allows for early and accurate detection of spoilage organisms in the beverage production process, applicable across the beverage testing industry [2] - The assay can detect over 100 strains of spoilage microorganisms, including preservative-resistant yeasts and molds, in a single qPCR reaction, which is a unique offering in the market [5] - By reducing testing time by up to 50% compared to traditional culture methods, the assay enhances manufacturers' confidence in batch release and improves consumer trust in beverage quality [6] Market Context - The global PCR market was valued at $4.90 billion in 2021 and is projected to grow at a CAGR of 8.7%, reaching $8.04 billion by 2027, driven by the rise in pathogen-related diseases and technological innovations [8] Financial Performance - Thermo Fisher has a market capitalization of $216.42 billion, with a Zacks Consensus Estimate forecasting a 3.9% increase in earnings and a 3.2% growth in revenues year-over-year [4] - TMO shares experienced a slight decline of 0.4% to close at $573.79 following the announcement, but the company has shown a positive trend with an 11.2% increase in share price over the past year compared to a 2.1% decline in the industry [3][11] Strategic Initiatives - In addition to the new assay, Thermo Fisher has opened an Advanced Therapies Collaboration Center in Philadelphia, enhancing its support for emerging startups and biopharma organizations [10]
Why Abbott is paying $21 billion for Exact Sciences and its Cologuard cancer test
MarketWatch· 2025-11-20 13:43
Core Insights - Abbott is entering the cancer-testing market through its acquisition of Exact Sciences, the maker of the Cologuard test, valued at $21 billion [1] Company Summary - The acquisition positions Abbott to expand its portfolio in the diagnostics sector, particularly in cancer detection [1] - Exact Sciences is known for its innovative Cologuard test, which is a non-invasive screening tool for colorectal cancer [1] Industry Summary - The cancer-testing market is experiencing growth, driven by increasing demand for early detection and non-invasive testing methods [1] - Abbott's move reflects a broader trend in the healthcare industry towards consolidation and diversification in diagnostics [1]
Intelligent Bio Solutions to Participate in Noble Capital Markets’ 21st Annual Emerging Growth Equity Conference on December 2-3, 2025
Globenewswire· 2025-11-20 13:30
Core Insights - Intelligent Bio Solutions Inc. (INBS) is participating in the Noble Capital Markets' 21st Annual Emerging Growth Equity Conference on December 2-3, 2025, in Boca Raton, Florida [1][2] Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions [4] - The company's Intelligent Fingerprinting Drug Screening System utilizes fingerprint sweat analysis, aiming to revolutionize portable testing with potential applications in various fields [4] - The system is designed to be hygienic and cost-effective, screening for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, with sample collection in seconds and results in under ten minutes [4] - Current customer segments outside the U.S. include construction, manufacturing, engineering, transport and logistics, mining, drug treatment organizations, and coroners [4]
Exact Sciences (EXAS) Climbs to 2-Year High on Abbot Merger Reports
Yahoo Finance· 2025-11-20 11:27
Core Insights - Exact Sciences Corp. is experiencing significant stock performance, reaching a two-year high amid acquisition talks with Abbott Laboratories, potentially marking Abbott's largest acquisition to date [1][2]. Stock Performance - During intra-day trading, Exact Sciences' stock peaked at $89.67, ultimately closing up by 23.68% at $86.18 [2]. Acquisition Talks - Exact Sciences and Abbott Laboratories are reportedly in advanced discussions regarding the acquisition, with a potential announcement expected in the coming weeks [3]. Financial Performance - Exact Sciences narrowed its net loss for Q3 by 48.77%, reporting a loss of $19.59 million compared to $38.24 million in the same quarter last year [4]. - Revenues for the same period increased by 20%, reaching $850.7 million, up from $708.6 million year-on-year, driven by strong performance in screening and precision oncology segments [4]. Future Guidance - The company raised its full-year revenue guidance to a range of $3.22 billion to $3.235 billion, up from a previous estimate of $3.13 billion to $3.17 billion [5]. - Adjusted EBITDA guidance was also increased to $470 million to $480 million, compared to the earlier range of $455 million to $475 million [5].
Market Braces for NVIDIA Earnings Amid AI Trade Scrutiny; Trump Aides Slow-Walk Semiconductor Tariffs
Stock Market News· 2025-11-19 19:08
Group 1: NVIDIA Earnings Report - NVIDIA's upcoming earnings report is a critical market stress test, with expectations for a 50%+ surge in profit and revenue to validate aggressive AI spending [2][9] - Analysts anticipate Q3 revenue to reach at least $55 billion to maintain market confidence in the AI sector [2][9] Group 2: Semiconductor Tariffs - The Trump administration is reportedly delaying the imposition of promised semiconductor tariffs on China to avoid new trade wars and supply shocks, particularly concerning rare earths [3][9] - Despite the current delay, there is potential for "triple-digit duties" to be imposed abruptly, creating uncertainty in the global technology and trade landscape [3][9] Group 3: Corporate Acquisitions - Abbott Laboratories is nearing an agreement to acquire Exact Sciences, indicating a trend of strategic acquisitions in the medical diagnostics industry focused on cancer detection [4][9] Group 4: Defense Sector Collaboration - Northrop Grumman and MBDA in Germany have formalized a Memorandum of Understanding to enhance Germany's air and missile defense capabilities, reflecting ongoing international defense collaborations [5][9] Group 5: Federal Reserve Operations - The New York Federal Reserve accepted $6 million in its Standing Repo Facility operations, highlighting the influence of regulations on the Federal Reserve's balance sheet and monetary policy [6]