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Tempus AI Advances Following FDA Clearance for Cardiac Imaging Platform Tempus AI (NASDAQ: TEM) shares advanced significantly on Thursday, September 11, 2025, following the announcement of a key regulatory milestone. The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the company's updated Tempus Pixel cardiac imaging platform, a development that reinforced investor confidence in AI-driven healthcare technology. The Event in Detail The FDA's 510(k) clearance for the updated Tempus Pixel platform significantly enhances its capabilities for cardiac Magnetic Resonance (MR) image analysis. This AI-powered system now allows for the generation of T1 and T2 inline maps, which provide precise numerical values to cardiac tissue characteristics. This advanced functionality aids clinicians in detecting conditions such as fibrosis, inflammation, or edema that might otherwise go undetected. A crucial aspect of this update is the platform's ability to create detailed DICOM maps directly from raw MRI data, even when the scanner itself does not produce them, offering comprehensive tissue assessment. Chris Scotto Divetta, Senior Vice President of AI Applications at Tempus AI, stated: > "This marks another important regulatory milestone for Tempus and underscores our commitment to advancing AI-driven imaging technology that is both scientifically rigorous and clinically meaningful." Beyond cardiac imaging, Tempus AI has strategically diversified its portfolio through in-house development and acquisitions. The company's offerings include AI-based analytical tools for CT scans and X-rays, integrating AI-powered imaging tools through its 2022 acquisition of Arterys and, more recently, Paige, an AI company specializing in digital pathology. This expansion strengthens Tempus AI's platform across medical imaging and pathology. Analysis of Market Reaction The regulatory approval served as a significant catalyst for Tempus AI's stock, which surged approximately 14% on Thursday, substantially outperforming the S&P 500's 0.9% gain. This positive market response was further bolstered by the company's robust second-quarter earnings report, released days prior. Tempus AI reported revenue of $314.6 million, an increase of approximately 90% year-over-year, surpassing Wall Street expectations of $297.8 million. The adjusted loss per share of $0.22 was also better than the estimated loss of $0.25. Consequently, Tempus AI raised its full-year revenue guidance, signaling an improving financial trajectory. Broader Context & Implications Tempus AI's stock has demonstrated remarkable performance year-to-date, rallying 152.2%, significantly outpacing the industry's 28.5% growth and the S&P 500's 12.8% improvement. This sustained upward trend reflects investor optimism regarding the company's position within the rapidly expanding AI in Radiology Market. This sector is projected to grow to $15.7 billion by 2035, at a Compound Annual Growth Rate (CAGR) of 19.56% from 2025 to 2035. Despite strong growth and regulatory wins, valuation metrics for Tempus AI indicate a premium. The company trades at a forward 12-month Price-to-Sales (P/S) ratio of 10.02x, compared to an industry average of 5.92x. Its Price/Book ratio stands at 49.82. Analysts maintain a "Moderate Buy" consensus rating; however, the average price target ranges from $70.17 to $73.45, suggesting a potential downside of 15% to 19.71% from current price levels of approximately $88.78 to $88.84. Recent insider selling activity, including significant share sales by the CFO and COO, also warrants consideration, totaling approximately -$22.5 million in the past 90 days. Expert Commentary While the regulatory clearance provides strong validation, analysts highlight that the ultimate success for Tempus AI will hinge on the adoption rates of its innovative AI tools and securing reimbursement momentum for its comprehensive genomic and AI analytics. This area still faces uncertainty, posing a potential limitation on the full monetization of its product pipeline. Looking Ahead The FDA clearance for Tempus Pixel positions Tempus AI as a key player in the $1.2 billion cardiac imaging market and the broader AI in medical imaging landscape. The company's modular AI architecture also suggests potential expansion into other areas such as oncology or neurology, which could diversify future revenue streams. However, the path to sustained growth will require overcoming challenges related to reimbursement policies for new and AI-enabled diagnostic tests, which are crucial for scaling revenue. Investors will be closely watching for progress in clinical adoption and favorable reimbursement developments in the coming quarters to assess the company's ability to convert technological innovation into long-term financial performance.
Tempus AI, Inc. announced the publication of a study in JCO Precision Oncology validating its PurIST® algorithmic diagnostic for advanced pancreatic pancreatic cancer, supporting its integration into clinical care for informing first-line chemotherapy selection and improving patient outcomes. This validation is expected to strengthen Tempus AI's market position in the growing precision oncology diagnostics sector. Technology Sector Gains as Tempus AI's Diagnostic Validation Fuels Optimism U.S. equities saw gains as investors reacted to significant developments in the biotechnology and AI in healthcare sectors. Of particular note, Tempus AI, Inc. (NASDAQ: TEM) announced the publication of a study in JCO Precision Oncology that validates its PurIST® algorithmic diagnostic, designed to guide first-line chemotherapy selection for patients with advanced pancreatic cancer. This development underscores the increasing role of artificial intelligence in precision medicine and has generated positive sentiment around TEM stock. PurIST® Validation: A New Era for Pancreatic Cancer Treatment The published study provides the largest real-world evidence to date supporting the integration of PurIST® into routine clinical care for patients with advanced pancreatic ductal adenocarcinoma (PDAC). Developed in collaboration with GeneCentric, PurIST® is an RNA-based algorithm that classifies PDAC tumors into "classical" or "basal" subtypes. This classification is crucial for informing treatment decisions, as clinicians have historically lacked robust biomarkers to guide optimal therapy selection for this highly lethal malignancy, which has a five-year survival rate of just 12%. Key findings from the study include: Prognostic Value: Among patients treated with FOLFIRINOX (FFX), those with the classical subtype demonstrated a significantly longer median overall survival of 11.8 months, compared to 7.0 months for basal subtype patients. Predictive Value: Classical subtype patients with good performance status who received FFX showed a 33% relative risk reduction in death when compared to those treated with gemcitabine plus nab-paclitaxel (GnP). These results establish PurIST® as both a prognostic and predictive biomarker, enabling more personalized and potentially more effective treatment strategies for PDAC patients. Market Reaction and Financial Implications for Tempus AI The scientific validation of PurIST® is expected to strengthen Tempus AI's market position and contribute to its top-line growth. TEM shares have rallied significantly in the past year, advancing 67.4%. This performance outpaces the broader industry's 21.4% growth and the S&P 500 composite's 19.4% improvement over the same period. Despite strong stock performance, the company's valuation appears elevated, with Tempus AI currently trading at a forward 12-month Price-to-Sales (P/S) ratio of 9.56X, considerably higher than the industry average of 5.88X. For fiscal year 2024, Tempus AI reported revenue of $693.40 million, marking a 30.38% increase from the previous year. However, the company also reported losses of -$746.33 million in 2024, an increase of 180.6% compared to 2023. Analyst firm HC Wainwright recently raised its price target for TEM from $90 to $98, while maintaining a "buy" rating, signaling a potential 13.5% upside. This suggests a degree of confidence in the company's long-term prospects, despite a recent 8-cent downward revision in its loss per share estimate for 2025 over the past 30 days. Broader Context: Precision Oncology Market Expansion The global pancreatic cancer treatment market is projected to reach $5.84 billion by 2030, exhibiting a Compound Annual Growth Rate (CAGR) of 12.3% from 2025 to 2030. Factors driving this growth include unhealthy lifestyles, alcohol consumption, and obesity. Tempus AI's PurIST® is strategically positioned to capitalize on this expanding market, enhancing its presence in precision oncology diagnostics. This development aligns with a broader trend towards personalized medicine, where AI-powered diagnostics are becoming increasingly vital for guiding therapeutic decisions. The successful commercialization of PurIST® could cement Tempus AI's role as a key player in providing biomarker-driven therapy selection, a growing segment within the biotechnology and AI in healthcare sectors. Looking Ahead: The Future of AI in Cancer Care The validation of PurIST® represents a significant step forward in leveraging AI to improve outcomes for patients with advanced pancreatic cancer. As Tempus AI continues to develop and integrate its AI-driven diagnostic tools, the market will closely watch for further advancements in precision medicine. The ability of such diagnostics to inform personalized treatment plans suggests a continued shift in cancer care paradigms, potentially attracting further investment and partnerships within the AI in healthcare and biotechnology industries. Key factors to watch include the broader adoption of PurIST® in clinical settings and its impact on Tempus AI's financial trajectory amidst its high valuation.
Tempus AI (NASDAQ: TEM) has significantly advanced its position as a data and artificial intelligence (AI) engine in precision oncology, marked by robust financial results and key acquisitions. The company's strategic moves are solidifying its competitive landscape and have generated optimistic outlooks from analysts, despite the stock's inherent volatility. Opening Tempus AI (NASDAQ: TEM) has demonstrated significant progress in its strategic shift towards becoming a premier data and artificial intelligence (AI) engine for the precision oncology market. This transformation is underscored by the company's robust financial results in the second quarter of fiscal year 2025 and strategic acquisitions aimed at solidifying its competitive position. These developments have garnered bullish sentiment among market participants, even amidst the stock's notable volatility. The Event in Detail Tempus AI reported a strong financial performance for Q2-2025, with revenue reaching $314.6 million, marking an 89.6% year-over-year (Y/Y) increase. The company's Genomics business, considered a foundational data-generating engine, experienced accelerated growth of 115.3% Y/Y, contributing $241.8 million to revenue. This acceleration was partly driven by a quickening in core oncology testing volume growth rate from 20% in the previous quarter to 26% in Q2-2025. Complementing this, the Data and Services business grew 35.7% to $72.8 million, with its Insights data licensing segment showing solid 40.7% growth. Tempus AI's quarterly gross profit surged by 158.3% to $195 million, outpacing its revenue growth, which indicates significant operating leverage. The aggregate non-GAAP gross margin expanded by 6 percentage points Y/Y to 62.8%. From a profitability standpoint, the adjusted EBITDA narrowed significantly from a loss of $31.2 million in Q2-2024 to a loss of only $5.6 million in Q2-2025. This sequential improvement has led Tempus AI to uplift its FY2025 guidance, projecting approximately $1.26 billion in revenue and a positive adjusted EBITDA of around $5 million, representing a $110 million Y/Y improvement. Key strategic moves include the acquisition of Paige, an AI company specializing in digital pathology, for $81.25 million, paid predominantly in Tempus common stock. This acquisition is pivotal, integrating nearly 7 million digitized pathology slides and expanding Tempus AI's dataset and technical expertise. Paige also brings the first FDA-cleared AI application in pathology. Additionally, Tempus AI secured a multi-year $200 million deal with AstraZeneca and Pathos AI to build a large multimodal foundation model in oncology. The non-exclusive nature of this deal positions Tempus AI as a preferred partner for major pharmaceutical companies seeking to develop similar proprietary AI models. Analysis of Market Reaction The market's positive reaction to Tempus AI's developments stems from its robust strategy to establish a defensible "multimodal data moat". The integration of genomics with digital pathology through the Paige acquisition, coupled with strategic partnerships, creates a unique and comprehensive dataset that is difficult to replicate. This directly supports bullish scenarios for TEM stock valuations. Tempus AI is actively transitioning from primarily a diagnostics provider to a leading data and AI platform. This shift is powered by its "data flywheel", where accelerating genomics volume directly scales its high-margin Data & Services business, thereby becoming a significant revenue-generating mechanism. The company's ability to grow gross profit faster than revenue points to strong operating leverage, signaling a clearer path to adjusted EBITDA profitability. Attaining positive adjusted EBITDA in FY2025 is viewed as a significant inflection point, expected to transform Tempus AI from a cash-burning growth entity to a financially stabilized one. This re-rating potential of the TEM stock price reflects growing confidence in the company's strategic direction and its capacity to monetize its expanding AI capabilities and data assets in the precision oncology market. Broader Context & Implications Over the past year, TEM stock has delivered a total return of +31.93%, outperforming direct genomics and health-tech benchmarks. Its year-to-date return stands at an impressive 127%. However, the stock's journey has been characterized by considerable turbulence, with massive price swings including a high of +50.62% and a low of -46.40% within a year. This indicates Tempus AI stock is highly sensitive to news and market sentiment. Its 24-month beta of 3.18 signifies that it is over three times more volatile than the broader market, with a high short interest of 15.39% further contributing to this volatility, potentially leading to sharp upward moves during positive news events, such as short squeezes. Currently, TEM stock is trading around $76.29. Technical analysis suggests support levels near $75-$74, with a deeper support around $39.05. Analysts project a potential 15-32% stock upside to $65-$75 by 2025. More optimistic technical price targets based on Fibonacci extension levels indicate potential appreciation marks by Q2-2026, with a first major resistance at approximately $96.85. Should the stock overcome this, the next objective is $122-$123.8, representing a gain of about 60% from current levels. The most optimistic target for Q2-2026 is $163.45-$164.65, implying a potential 110%+ price gain. While the growth prospects are strong, the company's high valuation necessitates near-flawless execution. An Altman Z-Score of 2.19 places Tempus AI in a 'financial grey zone,' suggesting a moderate degree of instability risk that warrants caution, though it does not signal immediate distress. Expert Commentary Eric Lefkofsky, Founder and CEO of Tempus, underscored the significance of the Paige acquisition, stating, > "As we embark upon building the largest foundation model that's ever been built in oncology, the acquisition of Paige substantially accelerates our efforts." Razik Yousfi, CEO and CTO of Paige, echoed this sentiment, emphasizing the broader vision: > "We've always believed that the future of cancer care and precision medicine lies in harnessing the full potential of AI to redefine what's possible in digital pathology and transform how cancer is detected, understood, and treated." Looking Ahead Investors will closely monitor several key factors in the coming quarters. Continued genomics volume growth (aiming for 25%+ Y/Y) and consistent momentum in the Data & Services business (stable 30%+ revenue growth) are crucial. Furthermore, sustained sequential improvement in adjusted EBITDA will be a strong indicator of the company's path to profitability. An external dependency to watch is the anticipated timeline for securing reimbursement for Minimal Residual Disease (MRD), projected for the end of 2025. Any delay in this area could impact both volume growth and average selling price (ASP). Primary risks include the demanding nature of Tempus AI's high valuation, potential technical and integration challenges following its acquisitions, and a continued dependency on external factors like reimbursement policies. The company's ability to achieve positive cash flow in the medium term will also be critical to prevent the need for more dilutive financing, which could be negatively received by the market and impact stock performance.
The current price of TEM is $87.98, it has increased 1.12% in the last trading day.
Tempus AI Inc belongs to Life Sciences Tools & Services industry and the sector is Health Care
Tempus AI Inc's current market cap is $15.2B
According to wall street analysts, 13 analysts have made analyst ratings for Tempus AI Inc, including 5 strong buy, 6 buy, 7 hold, 0 sell, and 5 strong sell
Tempus AI (TEM) is ripping because it secured a key FDA clearance for its AI-powered cardiac imaging platform, Tempus Pixel, on September 11, 2025. This news sent the stock soaring over 13% to a 7-month high as it signals a major expansion from oncology into the lucrative cardiology market.
Looks like you're noticing the pump. Let's break down whether this is a real signal or just noise before you ape in.
The Fundamental Catalyst: FDA Green Light The main driver is the 510(k) clearance from the U.S. Food and Drug Administration for an updated version of Tempus Pixel. This isn't just a minor update; it enhances the platform's cardiac MR image analysis capabilities, effectively giving Tempus a new, high-growth market to tackle beyond its core cancer focus. The market reacted immediately, with the stock jumping from the mid-$70s to nearly $89 on the news. This was supported by other positive developments, including a collaboration with Renalytix and the clinical validation of its PurIST test for pancreatic cancer.
Technical Picture: Bullish but Stretched The chart is screaming bullish, but you might be late to the party, bro.
The Alpha: Insiders Are Cashing Out Here's the part the headlines won't tell you. While retail and the market are FOMO-ing in, insiders are heading for the exit.
The narrative is strong with the FDA approval, but the combination of a technically overbought chart and heavy insider selling is a massive red flag. The insiders are using this pump as their exit liquidity. Don't become their exit liquidity, babe.