Gilead to Acquire Investigational Oral IL-23R Inhibitor HCXT-2001, Strengthening Its Inflammation Pipeline in IBD

Gilead expects the acquisition to reduce fourth-quarter 2026 GAAP and non-GAAP EPS by approximately $0.79 to $0.83.

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-- Clinical Program Adds a Potentially Differentiated Oral Peptide IL-23 Receptor Inhibitor to Gilead’s Inflammation Portfolio --

-- HCXT-2001 Has Potential as a Monotherapy or in Combination with Other Gilead Programs to Address Unmet Needs in Immune-Mediated Inflammatory Diseases --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has entered into a definitive agreement to acquire an oral IL-23R inhibitor program, including lead asset HCXT-2001, from PepStar Therapeutics Limited, a privately held, clinical-stage biotechnology company.

Key Highlights

• HCXT-2001 is an investigational, clinical-stage, oral, macrocyclic peptide inhibitor of IL-23R with an extended half-life, offering a potentially differentiated approach to oral IL-23 pathway inhibition. IL-23R is a clinically validated target in immune-mediated inflammatory diseases, including Inflammatory Bowel Diseases (IBD), with potential applications in psoriasis.
• The transaction provides Gilead with worldwide rights to the IL-23R inhibitor program, including HCXT-2001, and further strengthens Gilead’s growing inflammation and immunology portfolio, where the company is building depth and optionality in selected immune-mediated diseases through multiple complementary mechanisms and modalities.

“HCXT-2001 adds a potentially differentiated oral approach to our growing inflammation pipeline, reflecting our commitment to addressing significant unmet patient needs,” said Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead. “We see potential for HCXT-2001 alone or in combination, including with emvistegrast, as a daily oral treatment for people living with IBD.”

“We are excited for Gilead to take HCXT-2001 forward and believe their scientific expertise and global development capabilities can help realize the full potential of this novel oral IL-23R inhibitor,” said Haibing Guo, Founder and CEO of PepStar. “This transaction marks a major milestone for our company and underscores the strength of our proprietary oral peptide platform. I feel incredibly proud of what our team has accomplished in just three years and excited about what lies ahead as we continue bringing innovative medicines to patients around the world.”

Transaction Details

Under the terms of the agreement, Gilead will acquire an oral IL-23R inhibitor program, including lead asset HCXT-2001, from PepStar for $1.275 billion in upfront cash consideration, subject to customary adjustments, which is payable at closing. Closing of the transaction is subject to certain customary conditions. The transaction is expected to close in the fourth quarter of 2026.

This transaction is expected to reduce Gilead's GAAP and non-GAAP EPS by approximately $0.79 to $0.83 in the fourth quarter of 2026.

Lazard is acting as the exclusive financial advisor for Gilead. Centerview Partners LLC is acting as the exclusive financial advisor for PepStar. Covington & Burling LLP and Mayer Brown LLP are serving as legal counsel to Gilead. Sidley Austin LLP is representing PepStar and Wilson Sonsini Goodrich & Rosati LLP are serving as patent counsel to PepStar.

Advancing Gilead's Commitment to Inflammation

Gilead is committed to advancing innovative treatments with the potential to transform care for people living with chronic inflammatory conditions.

The company is building a disciplined, differentiated inflammation portfolio focused on significant unmet needs across immune-mediated diseases. By combining immunology expertise, precision oral medicines and a deep internal pipeline spanning complementary scientific approaches, Gilead has the optionality to advance both monotherapies and future combinations that address underlying drivers of disease and improve outcomes that matter most to patients.

Our areas of focus include inflammatory bowel disease, type 2 inflammatory diseases, lupus and B cell-mediated autoimmune diseases.

About HCXT-2001

HCXT-2001 is an investigational oral macrocyclic peptide inhibitor of IL-23R with an extended half-life currently in Phase 1 clinical trials, originally developed by PepStar Therapeutics Limited. Its safety and efficacy have not been established, and it has not been approved by any regulatory authority.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

Gilead Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and PepStar to complete the acquisition transaction in a timely manner or at all; the possibility that various closing conditions for the acquisition may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the acquisition; uncertainties relating to the timing or outcome of any filings and approvals relating to the acquisition; difficulties or unanticipated expenses in connection with integrating HCXT-2001 and related acquired assets; the effects of the acquisition on relationships with business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this acquisition; the ability of Gilead to advance the acquired pipeline assets, including HCXT-2001, and successfully commercialize such assets following the acquisition; Gilead’s ability to initiate, progress or complete clinical trials or studies within currently contemplated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving HCXT-2001 and/or emvistegrast; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently or prospectively under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

View source version on businesswire.com: https://www.businesswire.com/news/home/20261022181871/en/

Ashleigh Koss, Media
public_affairs@gilead.com

Jacquie Ross, Investors
investor_relations@gilead.com

Source: Gilead Sciences, Inc.

Key Terms

il-23r medical

IL-23R is a protein on certain immune cells that acts like a receptor for a signaling molecule called interleukin‑23 and helps start and sustain inflammatory responses. For investors, it matters because drugs that block or modify this receptor can reduce harmful inflammation in diseases such as psoriasis or inflammatory bowel disease; success or failure in trials and regulatory decisions for IL‑23R‑targeting therapies can materially affect the value of companies developing them—think of the receptor as a light switch that controls an overactive alarm system.

macrocyclic peptide medical

A macrocyclic peptide is a molecule made of amino acids whose backbone or side chains are joined to form a large, covalent ring rather than an open chain. The ring locks the peptide into a constrained three-dimensional shape, which commonly increases resistance to enzymatic breakdown and can improve how tightly and selectively it binds biological targets; macrocyclization can be achieved by joining the peptide ends (head-to-tail), linking side chains, or inserting a non‑peptidic bridge.

half-life medical

Half-life is the time it takes for a quantity (such as a drug in the body, a radioactive substance, or a decaying revenue stream) to decrease to half its original amount. Think of it like the time it takes for a hot cup of coffee to cool to half its initial warmth: it tells you how quickly the effect fades. For investors, half-life helps estimate how long a product’s impact, a payment stream, or a risk factor will meaningfully influence a company’s performance.

monotherapy medical

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.