FDA Delays PDUFA on HGSI's Benlysta (HGSI)

Collins Stewart published its research report on Human Genome Sciences

after the FDA announced it would delay the PDUFA on HGSI's Benlysta. In a note to clients, Collins Stewart writes, "removes the risk of a Class 2 resubmission with a 6-month review period. We continue to expect FDA approval of Benlysta for the treatment of SLE and do not expect patients of African descent to be restricted in the label, though it likely reflects that the drug was not studied in active renal or CNS (severe) lupus patients. However, given the delay, we now model for a 2Q11 launch (vs. 1Q11 previously), and are adjusting our Benlysta U.S. sales estimates for FY11 (to $60.1M from $127.9M previously) and beyond." Collins Stewart maintains its Buy rating and $37 price target on HGSI. HGSI closed Friday at $25.60.