Gilead buys HCXT-2001 IBD drug for $1.275B

Gilead Sciences has entered into a definitive agreement to acquire an oral IL-23 receptor inhibitor program, including lead asset HCXT-2001, from PepStar Therapeutics Limited. The transaction gives Gilead global rights to the IL-23R inhibitor program and is structured with an upfront cash payment of $1.275 billion. The acquisition is aimed at strengthening Gilead’s inflammation pipeline, particularly in inflammatory bowel disease.

The deal is expected to close in the fourth quarter of 2026, subject to customary closing conditions. Gilead anticipates that the transaction will reduce its fourth-quarter 2026 GAAP and non-GAAP earnings per share by approximately $0.79 to $0.83, reflecting the near-term financial impact of the upfront payment and associated costs.

HCXT-2001 is described as an investigational, clinical-stage, oral macrocyclic peptide inhibitor of the IL-23 receptor (IL-23R) with an extended half-life. The drug is currently being evaluated in Phase 1 clinical trials. As part of the broader IL-23R program being acquired, HCXT-2001 is intended for use in immune-mediated inflammatory diseases, including inflammatory bowel disease and psoriasis.

IL-23R is a protein on certain immune cells that acts as a receptor for interleukin-23 and helps initiate and maintain inflammatory responses. HCXT-2001’s macrocyclic design and extended half-life are highlighted as features that may offer a differentiated oral approach within Gilead’s inflammation portfolio, although its safety and efficacy have not yet been established and it has not been approved by any regulatory authority.

Gilead presents HCXT-2001 as a potential addition to its growing inflammation pipeline, with a particular focus on inflammatory bowel disease. The company notes that HCXT-2001 could be developed either as a monotherapy or in combination with other internal programs, including emvistegrast, to address unmet needs in immune-mediated inflammatory conditions.

In outlining the rationale for the transaction, Gilead emphasizes the therapeutic validation of IL-23R as a target in diseases such as inflammatory bowel disease and psoriasis. The acquisition of PepStar’s program is intended to reinforce Gilead’s position in this therapeutic area by adding a novel oral candidate that expands its options for future IBD treatment strategies.

Under the terms of the agreement, Gilead will make an upfront cash payment of $1.275 billion for the IL-23R inhibitor program, which includes HCXT-2001 and associated global rights. The financial impact is incorporated into Gilead’s outlook through the expected reduction of approximately $0.79 to $0.83 in GAAP and non-GAAP earnings per share for the fourth quarter of 2026.

Lazard is serving as exclusive financial advisor to Gilead on the transaction, while Centerview Partners LLC is acting as exclusive financial advisor to PepStar. Legal counsel for Gilead includes Covington & Burling LLP and Mayer Brown LLP, and PepStar is represented by Sidley Austin LLP, with Wilson Sonsini Goodrich & Rosati LLP providing patent counsel.