Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
AB Science S.A. (Euronext:AB) fell €1.61 (11%) to €12.67 on Friday after EMA's CHMP again recommended against conditional approval of masitinib for second-line treatment of gastrointestinal stromal tumors. AB Science was appealing a November CHMP negative opinion.
The committee said it still had "major concerns" about masitinib's benefits and said there were "outstanding problems related to quality control during its manufacture."
AB Science was off €0.61 on the week.
Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) was up $0.10 to $14.60 last week after FDA accepted and granted Priority Review to an NDA for Ryanodex dantrolene to treat malignant hyperthermia, seen as a potentially fatal reaction to drugs used in invasive procedures. The PDUFA date is July 22.
Knight Therapeutics Inc. (TSX-V:GUD) gained C$0.45 to C$5.30 last week after FDA approved Impavido miltefosine to treat cutaneous, mucosal and visceral leishmaniasis. Knight was formed this month by ex-shareholders of Paladin Labs Inc. to house Impavido after Paladin's acquisition by Endo International plc (NASDAQ:
Medivation Inc. (NASDAQ:MDVN) was off $1.23 to $66.53 last week after partner Astellas Pharma Inc. (Tokyo:4503) submitted an sNDA to FDA for Xtandi enzalutamide to treat chemotherapy-naïve patients with metastatic castration-resistant prostate