Eli Lilly gets a short cut at FDA for abemaciclib; Calyxt files for $100M IPO
⇨ Looking to play catch-up with the leaders in the CDK 4/6 cancer field, Eli Lilly scored the inside track at the FDA for abemaciclib, now under review for breast cancer. The agency is giving the drug a priority review, shaving four months off the agency’s review schedule. “We are pleased that the FDA has granted abemaciclib Priority Review, both as a potential monotherapy and combination therapy [with fulvestrant] for patients with advanced breast cancer,” said Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology.
⇨ Calyxt, the ag bio gene editing company set up by Cellectis CEO Andre Choulika, has filed for a $100 million IPO. Citigroup, Jefferies and Wells Fargo Securities are acting as joint book-running managers for the proposed offering. BMO Capital Markets and Ladenburg Thalmann are acting as co-managers.
⇨ Neon Therapeutics has enlisted the gene editing experts at CRISPR Therapeutics in its neoantigen approach to developing new cell therapies. The two companies announced a research collaboration Monday morning. There were no financial details in the release.