Alimera Science Inc. (NASDAQ:ALIM) fell $0.23 to $2.48 on Friday after FDA issued a complete response letter for an NDA for Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema. Alimera said FDA requested an additional clinical trial plus at least 12 months of follow-up. Alimera has rights to Iluvien from pSivida Corp. (NASDAQ:PSDV; ASX:PVA), which lost $0.93 (24%) to $2.87 on Friday. In Australia, the stock was down A$0.52 (12%) to A$3.84.
Alimera said it will meet with FDA's Dermatologic and Ophthalmic Drug Advisory Committee in January for advice. The complete response letter is the third from FDA for Iluvien.
Alimera lost $0.89 (26%) on the week. pSivida fell $1.74 (38%). In Australia, the stock lost A$1.15 (23%).
AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) gained $1.68 to $21.53 last week after FDA extended the PDUFA date by three months for an sNDA for Feraheme ferumoxytol. The new date is Jan. 21; it was Oct. 21. Feraheme is under review to expand its indication to include the treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment (see Analyst Picks, A18).
The product is approved to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD).
Amarin Corp. plc (NASDAQ:AMRN) fell $3.61 to $2.01 on Thursday after FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 9-2 against expanding the label of Vascepa icosapent ethyl. Amarin is seeking approval for