Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Biodefense company Emergent BioSolutions Inc. (NYSE:EBS) was up $0.44 to $22.47 last week after submitting a BLA to FDA for Anthrax immune globulin IV (AIGIV) to treat inhaled anthrax. AIGIV is being developed under a $160 million contract with HHS's Biomedical Advanced Research and Development Authority (BARDA).
Following an early surge to start the week, shares of Durata Therapeutics Inc. (NASDAQ:DRTX) fell $1.93 (12%) to $13.65 on Thursday after FDA approved a competing product and Jefferies' analyst Eun Yang published a note highlighting CMS's denial of a new technology add on payment (NTAP) for Durata's Dalvance dalbavancin, which the company launched in the U.S. in July for acute bacterial skin and skin structure infections (ABSSSIs). The NTAP denial came in a CMS final rule released earlier in the week. FDA approved Orbactiv oritavancin from The Medicines Co. (NASDAQ:MDCO) to treat ABSSSIs late Wednesday.
Durata, which also reported 2Q14 results on Thursday, ended the week up $1.35 (11%) to $14.15.
Incyte Corp. (NASDAQ:INCY) gained $0.75 to $47.68 last week after FDA accepted and granted Priority Review to an sNDA for ruxolitinib to treat polycythemia vera in patients who have had an inadequate response to or are intolerant of hydroxyurea. The PDUFA date is Dec. 5.
The drug is approved in the U.S. as Jakafi for intermediate or high-risk myelofibrosis, including primary MF and post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
The Medicines Co. (NASDAQ:MDCO) was up $1.14 to $24.45 last week after FDA approved an NDA for Orbactiv oritavancin to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by Gram-positive bacteria. The drug is under review in Europe to treat complicated skin and skin tissue infections (cSSTIs) caused by Gram-positive bacteria.
PTC Therapeutics Inc. (NASDAQ:PTCT) fell $1.13 to $26.61 last week after the European Commission granted conditional approval to Translarna ataluren to treat nonsense mutation Duchenne muscular dystrophy (DMD). The company expects to report