Wk chg

11/1 cls

Alimera Sciences Inc. (NASDAQ:ALIM)


Simos Simeonidis


Outperform (from market perform)



Simeonidis said Alimera is "significantly" undervalued following the recent sell-off after FDA issued a complete response letter for an NDA for Iluvien fluocinolone acetonide intravitreal implant to treat diabetic macular edema (DME) (see BioCentury, Oct. 28). While Alimera is trading at around $2 per share, Simeonidis said Iluvien is worth about $4 per share in the EU, where it is approved for chronic DME, even using conservative penetration assumptions. He noted that "positive U.S. news would be all upside."

Amarin Corp. plc (NASDAQ:AMRN)


Joseph Schwartz


Market perform (from market outperform)



Schwartz also lowered his target to $2 from $6 after Amarin disclosed in a SEC filing that FDA revoked an SPA for the company's Phase III ANCHOR trial, which evaluated Vascepa icosapent ethyl in combination with statins to treat high triglycerides in patients with mixed dyslipidemia. The agency said it no longer considers a change in serum triglyceride levels - the trial's primary endpoint - sufficient to establish effectiveness in the indication (see B11). Amarin is seeking approval based on the data and Schwartz does not believe FDA will approve the sNDA by its Dec. 20 PDUFA date. Amarin markets Vascepa in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia.