Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Alkermes plc (NASDAQ:ALKS) gained $1.49 to $44.73 last week after submitting an NDA to FDA for aripiprazole lauroxil to treat schizophrenia. The product is a once-monthly, injectable formulation of aripiprazole that uses Alkermes' LinkeRx technology.
Amgen Inc. (NASDAQ:AMGN) was up $6.56 to $139.38 last week after a pair of regulatory announcements. FDA accepted and granted Priority Review to an NDA for ivabradine to treat chronic heart failure (CHF). The selective If channel inhibitor is already marketed as Procoralan in about 100 countries outside the U.S.
Later in the week, Amgen submitted a BLA to FDA for evolocumab to treat high cholesterol. The application is the first in the U.S. for a PCSK9 program. Amgen plans to submit a regulatory application in the EU this quarter, with a submission in Japan slated for next year.
Basilea Pharmaceutica AG (SIX:BSLN) was off CHF0.40 to CHF100.40 the week of Aug. 18 after EMA accepted for review an MAA for isavuconazole to treat invasive aspergillosis and mucormycosis (zygomycosis).
BTG plc (LSE:BTG) was up 9.5p to 640.5p last week after the China Food and Drug Administration (CFDA) approved BTG's DC Bead to treat patients with malignant hypervascularized tumors like hepatocellular carcinoma (HCC). DC Bead is a drug-eluting bead for controlled release of doxorubicin or irinotecan. SciClone Pharmaceuticals Inc. (NASDAQ:SCLN), which has exclusive Chinese commercialization rights to the product, gained $0.52 to $6.86 on the week.
Cubist Pharmaceuticals Inc. (NASDAQ:CBST) was up $1.14 to $66.06 on Aug. 22 after EMA accepted for review an MAA for ceftolozane/tazobactam to treat complicated urinary tract infections (cUTIs) and complicated intra-abdominal