Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Alimera Sciences Inc. (NASDAQ:ALIM) was off $0.04 to $8.36 on Friday after the company resubmitted an NDA to FDA for Iluvien to treat diabetic macular edema. According to Alimera, FDA indicated that the NDA will be classified as a Class 2 resubmission, with a six-month review. In December, the agency issued a complete response letter asking for additional analyses of safety and efficacy data through month 36 from the two Phase III FAME trials of Iluvien.
Alimera lost $0.07 on the week. It has rights to Iluvien from pSivida Corp. (NASDAQ:PSDV; ASX:PVA), which lost $0.03 to $3.85 on Friday and off $0.35 on the week.
BioMimetic Therapeutics Inc. (NASDAQ:BMTI) lost $5.19 (39%) to $8.11 last week despite FDA's Orthopedic and Rehabilitation Devices Panel voting 10-8 on Thursday that the benefits of Augment Bone Graft to treat foot and ankle fractures outweighed its risks as an alternative to autograft. BioMimetic shares had fallen $4.73 (35%) to $8.66 on Tuesday after FDA released briefing documents