Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

Regulatory milestones

Cubist Pharmaceuticals Inc. (NASDAQ:CBST) was off $1.66 to $68.44 last week after FDA's Anti-Infective Drugs Advisory Committee voted unanimously in favor of approval of Sivextro tedizolid to treat acute bacterial skin and skin structure infections (ABSSSI). The PDUFA date is June 20.

FDA's Anti-Infective Drugs Advisory Committee also voted unanimously in favor of approval of Dalvance dalbavancin (RQ-00000002) from Durata Therapeutics Inc. (NASDAQ:DRTX) to treat ABSSSI. The PDUFA date is May 26.

Durata was down $0.61 to $12.89 on the week.

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) was off $0.69 to $15.92 last week after EMA accepted for review an MAA for Zerenex ferric citrate to treat hyperphosphatemia in dialysis dependent and non-dialysis dependent patients with chronic kidney disease (CKD). The product is under FDA review for CKD in dialysis patients, with a June 7 PDUFA date.

MannKind Corp. (NASDAQ:MNKD) jumped $2.97 (74%) to $6.99 on Wednesday after FDA's Endocrinologic and Metabolic Drugs Advisory Committee said Afrezza is safe and effective to treat Type I and II diabetes. The PDUFA date for the dry powder formulation of insulin plus an inhaler is April 15.

MannKind finished the week up $2.04 (42%)

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