On December 10, Lynk Pharmaceuticals and Formation Bio announced that Formation Bio has acquired exclusive global rights (excluding Greater China) to LNK01006, Lynk Pharmaceuticals' next-generation, highly selective, central nervous system (CNS)-penetrant TYK2 inhibitor. The program will be advanced by Bleecker Bio, a newly formed subsidiary of Formation Bio.
LNK01006 recently received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate first-in-human studies in the United States. Formation Bio plans to commence a Phase 1 clinical trial in the first half of 2026.
LNK01006 is a next-generation, CNS-penetrant allosteric TYK2 inhibitor that combines potent, selective inhibition of TYK2-mediated cytokine signaling with a pharmacologic profile optimized for central immune modulation. Its selectivity and CNS exposure are designed to regulate immune signaling within the central nervous system, potentially modulating the immune responses implicated in a range of autoimmune and inflammatory diseases. Its unique pharmacologic profile also offers optionality to explore a variety of potential indications where central or "compartmentalized" immune pathways are believed to play a key pathogenic role.
Under the terms of the agreement, Lynk Pharmaceuticals will receive a minority equity stake in Bleecker Bio, an upfront payment, and additional development, regulatory, and commercial milestone payments, with total potential consideration of up to $605 million. Additionally, Lynk Pharmaceuticals will receive tiered royalties on potential future product sales.