On Thursday, the U.S. Food and Drug Administration (FDA) approved Guardant Health Inc.’s (NASDAQ:GH) Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with Braftovi (encorafenib) in combination with cetuximab and chemotherapy.
The accelerated approval for Braftovi was supported by data from Pfizer Inc.’s (NYSE:PFE) Phase 3 BREAKWATER trial.
Data
The study showed that treatment with encorafenib and cetuximab plus mFOLFOX6 chemotherapy significantly improved objective response rate, progression-free survival, and overall survival compared with standard care.
Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling.
It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and now colorectal cancer.
Guardant360 CDx expands access to non-invasive genomic testing for this high-risk patient population.
Using a simple blood draw to detect BRAF V600E and other clinically relevant genetic alterations, the test helps clinicians quickly identify patients eligible for FDA-approved treatments, enabling timely treatment decisions when tumor tissue is unavailable, insufficient, or when rapid initiation of therapy is clinically necessary.
Why It Matters
Colorectal cancer remains the second-leading cause of cancer-related deaths in the U.S., with BRAF V600E mutations present in approximately 8 to 10% of mCRC cases.
The latest FDA approval for Guardant 360 CDx marks the 25th companion diagnostic indication across multiple tumor types and builds on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.
On Monday, Guardant Health inked a multi-year collaboration with Merck & Co. Inc. (NYSE:MRK) to support the development and commercialization of Merck’s oncology portfolio using the Guardant Infinity Smart platform.
Last week, Guardant Health released preliminary fourth quarter 2025 revenues of $280 million, up 39% year over year, and 2025 sales were up 33% to $981 million, driven by oncology and shield screening volume.
GH Stock Surges on Strong Technical Indicators
The stock is currently trading 10% above its 20-day simple moving average (SMA) and 37.8% above its 100-day SMA, indicating strong short-term momentum. Over the past 12 months, shares have increased by 145.23% and are currently positioned closer to their 52-week highs than lows.
The RSI is at 68.24, which is considered neutral, while the MACD is above its signal line, indicating bullish momentum. The combination of a neutral RSI and a bullish MACD suggests mixed momentum, indicating potential for continued strength.
Upcoming Earnings: Analysts Eye GH’s Growth
Investors are looking ahead to the company’s next earnings report on February 19, 2026, with analysts expecting a loss of $(0.61) per share, up from $(0.62) a year ago, and revenue of $273.83 million, up from $201.81 million from the same quarter last year.
The stock carries a Buy rating among analysts with an average price target of $87.25, reflecting positive sentiment as investors monitor the stock ahead of the earnings release.
Guardant Health Scores High on Benzinga Edge
Below is the Benzinga Edge scorecard for Guardant Health, highlighting its strengths and weaknesses compared to the broader market:
- Momentum: Bullish (Score: 97.64) — Stock is outperforming the broader market.
The Verdict: Guardant Health’s Benzinga Edge signal reveals a strong momentum setup. While the stock’s high momentum score indicates robust performance, investors should remain cautious as they await further earnings updates.
GH Price Action: Guardant Health shares were up 2.27% at $118.37 at the time of publication on Thursday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
Photo by Tada Images via Shutterstock
Recent Comments