Collins Stewart Has $25 Target On Savient Pharmaceuticals (SVNT)
Collins Stewart has a $25 price target and is reiterating its Buy rating on shares of Savient Pharmaceuticals (NASDAQ: SVNT) as the company faces approval on September 14 for its gout drug.
In a note to clients, Collins Stewart writes, "SVNT faces two key binary events: 1) Krystexxa's PDUFA of Sept 14 for treatment-failure gout; and 2) a potential sale post approval. We believe there is a high-likelihood (~75%+) of approval as SVNT has fulfilled the Complete Response letter requirements (manufactured three commercial batches per the P3 manufacturing process within analytical specifications;
submitted 3- and 6-month stability data on the validation batches on July 28; submitted a safety update/REMS; BTG has remediated all 483 observations and was notified by the FDA in e-mail that a "FDA reinspection of BTG is not planned in support of the Krystexxa BLA prior to the PDUFA date". While delays could result from REMS/labeling discussions, recent amendments to the BLA filing, reorganization of the FDA division, and/or a required reinspection, we believe the probability is low. We believe Krystexxa is as an attractive asset for any rheumatology and/or orphan-focused company as it is a late-stage biologic targeting an orphan indication with significant unmet medical need in rheumatology and could secure premium pricing. We estimate peak WW Krystexxa sales of $700M+ (7K patients at $50K/patient/year)."
