Biotech Values

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Human Genome Sciences: Expect Positive FDA Update Soon

We are maintaining our 1-Overweight rating on shares of HGSI ahead of expected BLA acceptance for Benlysta. While concerns have emerged regarding apparent delay in communication of review status we understand that HGSI has yet to be contacted by FDA and we continue to expect 6-month priority review.

HGSI was expected to hear from FDA by August 10th regarding acceptance of its BLA for Benlysta in SLE and designation of 6-month priority review vs. 10-month standard review. While FDA guidance would suggest 60-day response from June 10 BLA submission, feedback from HGSI yesterday suggests that they have yet to receive communication from FDA and that the company remains optimistic regarding priority review.
We continue to believe that Benlysta review is straightforward and deserving of priority. Irrespective of review status we believe that likelihood of approval is high following 2 positive studies, favorable AE profile and significant unmet need in Lupus.