Core Insights - The FDA approved Guardant Health's Guardant360 CDx as a companion diagnostic for identifying patients with BRAF V600E-mutant metastatic colorectal cancer who may benefit from Braftovi treatment [1][4] - The approval is based on data from Pfizer's Phase 3 BREAKWATER trial, showing significant improvements in treatment outcomes [2] Group 1: Product and Approval Details - Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling, detecting multiple genomic alterations across solid tumors [2] - The test aids in identifying patients eligible for FDA-approved treatments using a simple blood draw, which is crucial when tumor tissue is unavailable [3] - Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S., with BRAF V600E mutations found in approximately 8-10% of metastatic colorectal cancer cases [4] Group 2: Financial Performance and Collaborations - Guardant Health reported preliminary fourth quarter 2025 revenues of $280 million, a 39% increase year over year, with 2025 sales reaching $981 million, up 33% [5] - The company entered a multi-year collaboration with Merck to support the development of Merck's oncology portfolio using the Guardant Infinity Smart platform [5] Group 3: Stock Performance and Market Sentiment - Guardant Health's stock is trading 10% above its 20-day simple moving average and 37.8% above its 100-day simple moving average, indicating strong short-term momentum [6] - Over the past 12 months, the stock has increased by 145.23% and is closer to its 52-week highs [6] - Analysts expect a loss of $(0.61) per share in the upcoming earnings report, with revenue projected at $273.83 million, up from $201.81 million a year ago [8] Group 4: Analyst Ratings and Market Position - The stock carries a Buy rating among analysts with an average price target of $87.25, reflecting positive sentiment ahead of the earnings release [9] - Guardant Health scores high on the Benzinga Edge, indicating strong momentum and outperforming the broader market [10]

Core Insights - Guardant Health, Inc. has announced a multi-year collaboration with Merck to support the development and commercialization of Merck's oncology portfolio using the Guardant Infinity Smart platform [1] - The collaboration aims to enhance the precision of oncology programs by ensuring that clinical trials have the necessary molecular clarity to identify the right patients for treatment [1] Company Overview - Guardant Health is a leading precision oncology company founded in 2012, focused on improving patient care and accelerating cancer therapies through advanced blood and tissue tests, real-world data, and AI analytics [2] - The company's tests are designed to improve outcomes across all stages of cancer care, including early screening, monitoring for recurrence, and treatment selection for advanced cancer patients [2] Collaboration Details - The collaboration includes using Guardant's portfolio of liquid and tissue biopsy tests as clinical trial enrolling assays in Merck's global clinical studies [4] - There will be an evaluation of opportunities to develop novel therapies using Guardant liquid biopsy tests as companion diagnostics [4] - The partnership will also focus on global commercialization of drugs and companion diagnostics in markets including the US, Asia-Pacific, UK, and EU [4]