BioCentury
ARTICLE | Company News

Aug. 2 Company Quick Takes: Daiichi's cancer drug gets U.S. approval, plus BioMarin, Acorda, Stemline and more

August 2, 2019 11:33 PM UTC

FDA approves Daiichi's pexidartinib
FDA approved Turalio pexidartinib from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to treat tenosynovial giant cell tumor. A Daiichi spokesperson told BioCentury the drug has been launched at a wholesale acquisition cost of $165 per capsule. In May, an FDA advisory committee voted 12-3 that the drug's benefits outweigh its risks. The small molecule inhibitor of CSF1R, c-Kit and FLT3 has a boxed warning describing risk of liver injury and is available only through a REMS. It is the first novel cancer drug Daiichi expects to launch in the U.S. (see "Daiichi's 2025 Cancer Goals").

BioMarin falls on quarterly earnings
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) fell $3.16 to $77.84 Friday after reporting 2Q19 earnings Thursday that missed analyst expectations, due in part to lower-than-expected sales of mucopolysaccharidosis drug Vimizim elosulfase alfa. Vimizim brought in $122.7 million, below consensus estimates of $138.1 million. The company reported $387.8 million in revenues, up 4% from 2Q18, but below the Street's estimates of $415.9 million. ...