Sept. 13 Company Quick Takes: FDA issues warning on CDK4/6 drugs; plus Castle Creek to buy Fibrocell and Eidos rebuffs BridgeBio

FDA warns of lung inflammation for CDK4/6 drugs
FDA issued a warning Friday that marketed CDK4/6 breast cancer drugs have been associated with a severe but rare risk of lung inflammation. In a review of past and ongoing clinical trials as well as post-market safety databases for the drug class, FDA identified cases of interstitial lung disease and pneumonitis which it said included fatalities, though no numbers were disclosed. The warning includes marketed CDK4/6 inhibitors Ibrance palbociclib from Pfizer Inc. (NYSE:PFE), Kisqali ribociclib from Novartis AG (NYSE:NVS; SIX:NOVN) and Verzenio abemaciclib from Eli Lilly and Co. (NYSE:LLY).

Castle Creek to buy Fibrocell for $63M
Castle Creek Pharmaceutical Holdings Inc. (Parsippany, N.J.) plans to buy cell and gene therapy company Fibrocell Science Inc. (NASDAQ:FCSC) for $63.3 million in cash, or $3 a share, representing a 63% premium over Fibrocell’s 30-day volume weighted average as of Sept. 11. In April, Castle Creek exclusively licensed commercial rights to Fibrocell’s gene therapy FCX-007, which is in Phase III testing for recessive dystrophic epidermolysis bullosa, with a BLA filing expected in 2021. Fibrocell has a second gene therapy candidate, FCX-013, in Phase II testing for scleroderma. Following the closing, which is expected fourth quarter, Fibrocell will become a privately held subsidiary of Castle Creek. Fibrocell closed up $1.09 (60%) to $2.92 on Friday (see “Castle Creek Gets U.S. Rights to Market Fibrocell’s Skin Disease Cell Therapy”)...