Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical group, welcomes the recent U.S. Food and Drug Administration (FDA) approval of Guardant360® Liquid CDx, the largest FDA-approved liquid biopsy panel, developed by Guardant Health, Inc. (Nasdaq: GH). This development was highlighted at the sidelines of the 5th Annual International Oncology Forum IOF 2026 in the UAE, where Hikma and Guardant Health were platinum sponsors.

Guardant360® Liquid CDx is the largest FDA-approved liquid biopsy panel (a type of test that detects cancer-related genomic material from a simple blood draw), offering a less invasive alternative to traditional tissue-based biomarker testing. Powered by Guardant's proprietary Smart Platform, the test integrates both genomic and epigenomic profiling from a single blood draw. It analyses a tumour's DNA mutations, allowing clinicians to make better-informed clinical decisions for patients with advanced cancer originating from solid organs. The test delivers a 100x wider genomic footprint and a several-fold increase in sensitivity for circulating tumour DNA (ctDNA) detection compared to the previous Guardant360 CDx. With this approval, the seven previously FDA-approved companion diagnostic indications for Guardant360 CDx transfer to Guardant360 Liquid CDx.

Hikma signed an exclusive agreement with Guardant Health, Inc. in 2024 for the commercialisation and marketing of its liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumour mutation profiling across all solid cancers in the Middle East and North Africa (MENA). Guardant is the only precision oncology company to offer a complete portfolio of cancer solutions in the region.

Commenting on this milestone, Mazen Darwazeh, Hikma's Executive Vice Chairman and Deputy CEO – MENA, said: "Our collaboration with Guardant Health is very important for introducing next-generation diagnostics in the MENA region, that can redefine cancer care. The recent FDA approval of Guardant360® Liquid CDx brings a highly advanced solution to clinicians, enabling a deeper understanding of tumour biology to guide precise treatment decisions. As a trusted and experienced partner in the region with a strong oncology portfolio, Hikma remains committed to enhancing access to precision medicine and delivering better outcomes for patients battling cancer.”

“Guardant Health is the only precision oncology company to have three solutions receive FDA approval, reinforcing our leadership in comprehensive molecular profiling across the cancer continuum. With our proprietary Smart Platform, clinicians have access to advanced molecular insights to inform their treatment selection decisions, marking a new era in advanced cancer care,” said Simranjit Singh, Chief Executive Officer, Guardant Health AMEA.

Results from Guardant360 Liquid CDx are available in as little as seven days once the sample is received in the laboratory, supporting more informed treatment decisions for patients regardless of tissue availability or line of therapy. Approved as a companion diagnostic across non-small cell lung cancer, colorectal cancer, and advanced breast cancer, it delivers a comprehensive view of tumour biology from a single blood draw.

Enquiries:

Mona Abdallah

Senior Director, MENA Communications & Corporate Affairs

MBAbdallah@Hikma.com

Dana Alhusseini

Associate Director, MENA Communications & Corporate Affairs

DAlhusseini@Hikma.com

Zaina AlAtiyat

Manager, MENA Communications & Corporate Affairs

ZAlAtiyat@hikma.com

About Hikma:

Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB/stable S&P, BBB/stable Fitch)

About Guardant Health

(Nasdaq: GH)

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.