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MN-60014

Gilead / OuroMN-60014

View on ACCC

Processing timeline

26

days

Filed

22 Apr 2026

Gilead - Ouro - Phase 1 determination

Decision

18 May 2026Gilead - Ouro - Phase 1 determination
Type
Notification
Outcome
Approved
Stage
Phase 1 - initial assessment
Status
Assessment completed

Parties

Acquirer(s)

Gilead Sciences, Inc. EIN 94-3047598

Target(s) or Vendor(s)

Ouro Medicines, LLC 202462212198

Other parties

None listed

Summary

Gilead Sciences, Inc., a US biopharmaceutical company, is acquiring all outstanding shares of Ouro Medicines, LLC, a US-based clinical-stage biotechnology company. This share acquisition focuses on the development of T cell therapies for autoimmune diseases, an area where both parties are active, with Ouro conducting trials in Australia.

Acquisition details

Gilead Sciences, Inc. (Gilead), through its wholly owned subsidiary Ojas Merger Sub LLC, proposes to acquire all of the outstanding shares of Ouro Medicines, LLC (Ouro) (the Acquisition). Gilead is a biopharmaceutical company incorporated in the United States. Globally, Gilead’s activities focus on advancing medicines to prevent and treat life-threatening diseases, including HIV, liver disease, coronavirus disease 2019 (COVID-19), inflammation and cancer. Its primary subsidiary in Australia is Gilead Sciences Pty. Ltd., through which Gilead supplies Australian customers with a range of medicines. Ouro is a privately-held, U.S.-based clinical-development stage biotechnology company focused on developing T cell engager (TCE) therapies for autoimmune diseases. Ouro’s lead product candidate, OM336 (gamgertamig), is a B cell Maturation Antigen (BCMA)-directed bispecific TCE binding to CD-3 on the T cell complex. Ouro does not currently market any products anywhere in the world and it only has early-stage development programs. Both Gilead and Ouro are active in the development of T cell therapies for the treatment of autoimmune diseases. Gilead does not have any marketed products but is engaged in Phase 1 clinical and preclinical research and development (R&D) pipeline activities, which are limited to autologous chimeric antigen receptor T cell (CAR-T) early-stage programs. Gilead’s clinical pipeline trials are for KITE-363 and Anito-cel, with potential indications being Systemic Lupus Erythematosus, IIM (myositis), relapsed/refractory Lupus Nephritis, relapsed/refractory Systemic Sclerosis and Chronic Inflammatory Demyelinating Polyneuropathy, relapsed/refractory Multiple Sclerosis and Generalized Myasthenia Gravis. Gilead does not have any manufacturing or R&D facilities in Australia but runs some clinical trials in Australia and employs an operations team in Australia to support those trials. Ouro is focused on developing TCE therapies for the treatment of autoimmune diseases; Ouro has no direct activities in Australia. Ouro is conducting two ‘basket studies’ as part of Phase 1b clinical development for OM336, with potential indications being autoimmune cytopenias and seropositive autoimmune disease. One of these trials has started recruiting patients in Australia via a Contract Research Organisation.

Industry

Broad:Industrial ManufacturingANZSIC 1841:Human Pharmaceutical and Medicinal Product ManufacturingANZSIC 6910:Scientific Research Services

Decisions and key events

18 May 2026Gilead - Ouro - Phase 1 determinationAttachmentPDF159.1 KB

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