Oct. 14 Company Quick Takes: Shionogi, Ultragenyx, BridgeBio-Eidos and MolMed

Imbalance in deaths likely focus of Shionogi advisory panel meeting
Briefing documents for an Oct. 16 meeting of FDA’s Antimicrobial Drugs Advisory Committee to discuss IV cefiderocol from Shionogi & Co. Ltd. (Tokyo:4507) to treat complicated urinary tract infections caused by Gram-negative bacteria suggest the panel is likely to focus on an increase in mortality in the treatment group in the CREDIBLE-CR study. In the draft questions for the panel, FDA asks the committee to discuss the mortality imbalance in the study as part of its overall risk-benefit assessment along with recommendations for labeling and/or additional studies; in its briefing material, Shionogi said it has “no conclusive reasons” for the mortality differences. “Shionogi is of the opinion that the difference in mortality is best understood by examining the detailed patient level information which gives a clear picture of the clinical context that led to the outcome of death,” the company added.

Ultragenyx’s UX007 under FDA review
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said FDA is reviewing an NDA for triheptanoin (UX007) to treat long-chain fatty acid oxidation disorders. Its PDUFA date is July 31, 2020. The company said FDA does not currently plan to hold an advisory committee meeting concerning the NDA (see “FDA Clarifies Path for Ultragenyx Submission”)...