Eli Lilly expands U.S. manufacturing and advances breakthrough therapy

Reuters reported Eli Lilly plans six new U.S. manufacturing plants as part of a previously announced at least $27 billion investment, and the FDA granted Breakthrough Therapy designation to its ovarian cancer drug sofetabart mipitecan after positive early trial results.

Eli Lilly has announced plans reported by Reuters to build six new manufacturing plants in the United States. The company previously said it would invest at least $27 billion to expand production and strengthen medical supply chains. Three plants were already confirmed in Alabama, Virginia, and Texas. Separately, the FDA granted Breakthrough Therapy designation on January 20 to Lilly's ovarian cancer drug sofetabart mipitecan after positive Phase 1a/b results. Key facts: - Reuters reported plans for six new U.S. manufacturing plants. - Lilly had previously announced at least $27 billion in investment and had four plants planned, with three confirmed in Alabama, Virginia, and Texas. - The FDA granted Breakthrough Therapy designation on Jan 20 to sofetabart mipitecan. - A Phase 1a/b study showed responses at all dose levels and across folate receptor alpha expression levels, with low rates of intestinal lung disease, peripheral neuropathy, and alopecia. - Sofetabart mipitecan is in a Phase 3 Framework-01 study as monotherapy for platinum-resistant ovarian cancer and Lilly is investigating it with the European Network for Gynecological Oncological Trial Groups. - The article mentions Bernstein reiterated an Outperform rating on Lilly and set a $1300 price target. Summary: These developments highlight Lilly's emphasis on enlarging U.S. manufacturing capacity and advancing an oncology candidate through expedited regulatory pathways. Next steps include construction on the manufacturing plans and continued clinical progress for sofetabart mipitecan as the Phase 3 study continues.