Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
The submission triggered a $5 million milestone payment to AcelRx from Gruenenthal, which has commercialization rights in Europe and Australia.
An NDA for the pre-programmed, handheld device that delivers a sublingual formulation of sufentanil is under FDA review, with a July 27 PDUFA date.
Basilea Pharmaceutica AG (SIX:BSLN) was off CHF5.95 to CHF97.55 last week after partner Astellas Pharma Inc. (Tokyo:4503) submitted an NDA to FDA for isavuconazole to treat invasive aspergillosis and invasive mucormycosis (zygomycosis).
Biogen Idec Inc. (NASDAQ:BIIB) was up $3.10 to $322.22 on Friday after the U.K.'s NICE issued a final appraisal determination recommending Tecfidera dimethyl fumarate to treat relapsing-remitting multiple sclerosis in a subgroup of patients who do not have highly active or rapidly evolving severe RRMS.
Biogen finished the week down $8.93 to $322.22.
Genmab A/S (CSE:GEN; OTCBB:GMXAY) was off €9.10 to €227.70 on Independence Day week after the European Commission approved a label expansion for Arzerra ofatumumab to include first-line treatment of chronic lymphocytic leukemia (CLL) in combination with chlorambucil or bendamustine in patients who have not received prior therapy or who are unsuitable for fludarabine-based therapy.
Partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Arzerra in the U.S. for first-line CLL and in the U.S. and EU for CLL refractory to fludarabine and alemtuzumab. The pharma has worldwide co-development and commercialization rights to the human mAb against CD20 from Genmab.
InterMune Inc. (NASDAQ:ITMN) was up $0.29 to $44.44 on July 3 after FDA accepted for review a resubmitted NDA for