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Oct. 28 Company Quick Takes: MOR106 dropped in atopic dermatitis; plus Blueprint, Merus, Gilead-Glympse, Heron and GSK

October 29, 2019 12:16 AM UTC

Galapagos, MorphoSys, Novartis discontinue atopic dermatitis program
With an interim analysis indicating futility of the Phase II IGUANA trial, MorphoSys AG (Xetra:MOR; NASDAQ:MOR), Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) and Novartis AG (NYSE:NVS; SIX:NOVN) terminated development of MOR106 in atopic dermatitis. The mAb against IL-17C was unlikely to meet the primary endpoint of reducing Eczema Area and Severity Index score. The partners are exploring a "future strategy" for MOR106 (see "Novartis in Atopic Dermatitis Deal with MorphoSys, Galapagos").

FDA splitting Blueprint's NDA in two
Blueprint Medicines Corp. (NASDAQ:BPMC) said FDA will split its NDA for avapritinib into separate applications to treat fourth-line gastrointestinal stromal tumors and PDGFRα exon 18-mutant GIST regardless of prior therapy. The company said FDA has requested the inclusion of top-line data from the Phase III VOYAGER trial in third- and fourth-line GIST, which are due in 2Q20. Blueprint acknowledged that the changes could require an extension of avapritinib's review past its Feb. 14, 2020, PDUFA date in the fourth-line indication. Blueprint fell $10.64 (14%) to $67.05 Monday; Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH), which also has a GIST program, was up $3.01 to $39.07...