Basilea Pharmaceutica AG (SIX:BSLN) fell CHF9.10 to CHF104.90 last week after it said FDA confirmed additional Phase III data would be required to support U.S. approval of ceftobiprole to treat pneumonia. The company said it does not plan to conduct new Phase III trials without a U.S. partner.
Gilead Sciences Inc. (NASDAQ:GILD) added $0.76 to $82.94 on Friday after submitting an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Sovaldi sofosbuvir to treat chronic HCV genotype 2 infection. The company already markets Sovaldi in the U.S., EU and Canada to treat HCV infection.
Gilead gained $1.74 on the week.
Hyperion, which markets Ravicti in the U.S. to manage chronic UCDs, has worldwide rights to the compound from Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX).
Look for shares of MannKind Corp. (NASDAQ:MNKD) to move this week. News came in the final hour of trading on Friday that FDA approved a resubmitted NDA for Afrezza to improve glycemic control in Type I and II diabetics.
MannKind shares jumped $2.97 (74%) to $6.99 on April 2 after FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted that Afrezza was