Formation Bio and Lynk Pharmaceuticals have announced that Formation Bio has acquired worldwide rights—excluding Greater China—to LNK01006, a next-generation, central nervous system (CNS)–penetrant TYK2 inhibitor. The asset, which recently received FDA clearance for first-in-human studies, will be developed under Formation Bio’s newly created subsidiary, Bleecker Bio.
The acquisition marks a significant strategic expansion for Formation Bio as it continues to build a pipeline of high-potential therapies supported by advanced AI-enabled drug development tools. The company plans to launch a Phase 1 clinical trial in the first half of 2026, bringing new momentum to its growing roster of clinical-stage assets.
LNK01006 is an allosteric TYK2 inhibitor engineered for potent and highly selective modulation of TYK2-mediated cytokine signaling. Unlike many TYK2 inhibitors that primarily act peripherally, LNK01006 is designed to penetrate the central nervous system, enabling targeted immune modulation within the brain and spinal cord. Its pharmacologic profile offers a unique opportunity to explore therapeutic applications across autoimmune and inflammatory diseases where central or compartmentalized immune pathways play an important pathophysiological role.
According to Formation Bio, the acquisition is closely aligned with its “Known In New” strategy—an approach focused on applying well-validated biological mechanisms to new disease areas with unmet medical needs. “This asset represents a prime example of what we call our ‘Known In New’ strategy of applying validated mechanisms to novel areas of high unmet need,” said David Steinberg, Chief Business Officer at Formation Bio. He emphasized that the company’s combination of expert scientific talent, robust clinical datasets, and state-of-the-art internal AI platforms enables the development of deeply informed hypotheses and efficient clinical execution.
Lynk Pharmaceuticals, founded by experienced drug discovery leaders from Johnson & Johnson, Merck, and Pfizer, has built a broad discovery platform focused on immunology and inflammation. LNK01006 exemplifies Lynk’s medicinal chemistry capabilities, incorporating a highly optimized scaffold designed for selectivity, metabolic stability, and CNS penetration. “We are excited to partner with Formation Bio to advance LNK01006 into the clinic,” said Zhao-Kui (ZK) Wan, CEO of Lynk Pharmaceuticals. He noted that Formation Bio’s advanced development infrastructure and AI-driven capabilities offer the ideal setting to translate the compound’s scientific promise into clinical impact.
The financial terms of the agreement include a minority equity stake for Lynk in Bleecker Bio, an upfront payment, and development, regulatory, and commercial milestones that could total up to $605 million. Lynk will also receive tiered royalties on future sales if the drug reaches the market. Pacific Bridge NY, an investment fund specializing in late-preclinical and clinical-stage life sciences, has joined as a minority co-investor in the new subsidiary.
Formation Bio’s model centers on acquiring and advancing promising therapeutic assets in-house, supported by dedicated operating teams, deep therapeutic expertise, and a proprietary AI platform designed to accelerate every stage of the development cycle. By integrating capital, technology, and clinical execution under one umbrella, the company aims to improve the probability of success while reducing development timelines.
The advancement of LNK01006 into upcoming clinical trials represents a significant step for both companies, opening the door to new therapeutic possibilities for CNS-related immune modulation and expanding the pipeline of next-generation TYK2-targeted therapies.