Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Alimera Sciences Inc. (NASDAQ:ALIM) gained $0.60 to $7.20 last week after resubmitting an NDA to FDA for Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema (DME). The company said the resubmission addresses issues raised by FDA in an October complete response letter and contains a safety update. Alimera markets Iluvien in Europe.
Alimera has rights to Iluvien from pSivida Corp. (NASDAQ:PSDV; ASX:PVA), which was off $0.55 (12%) to $3.89 on NASDAQ and off A$0.44 to A$4 in Australia for the week.
Cubist Pharmaceuticals Inc. (NASDAQ:CBST) was down $5.49 to $70.10 last week after FDA reviewers provided a summary of efficacy and safety data but did not take a position on approval of Sivextro tedizolid to treat acute bacterial skin and skin structure infections (ABSSSI). The PDUFA date is June 20.
FDA reviewers also provided a summary of data but did not take a position on approval of Dalvance dalbavancin (RQ-00000002) from Durata Therapeutics Inc. (NASDAQ:DRTX) for ABSSSI. The PDUFA date is May 26.
FDA's Anti-Infective Drugs Advisory Committee is scheduled