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Relypsa Plunges After Veltassa FDA Approval; Wedbush Says 'Misunderstanding' Creates Buying Opportunity

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  • Relypsa Inc (NASDAQ: RLYP) confirmed that the FDA has approved patiromer Veltassa for the treatment of hyperkalemia.
  • However, a misunderstanding has created a buying opportunity, Wedbush analysts assured in a report issued Thursday. The stock was down more than 18 percent on Thursday trading.
  • Consequently, the firm reiterated an Outperform rating on the stock, while raising its price target from $66 to $75.

As Wedbush analysts Liana Moussatos and Kelechi Chikere expected, the FDA officially permitted the use of Veltassa -dosed orally once a day- for the treatment of hyperkalemia. In fact, the experts highlighted, they believe the approved label puts no limitations on the potential use of the drug “in the acute / non-emergency setting as adjunct therapy or in the chronic setting.” The full package insert can be accessed through this link.

Wedbush’s Take

In the above-mentioned report, Wedbush analysts shared some comments regarding the FDA approval of Veltassa.

For starters, they said, they “believe the box warning on the label indicating POTENTIAL drug-drug interactions is easily addressable, a minor issue,” and thus, does not have an impact on the firm’s sales projections.

In fact, the experts assured they anticipate a successful launch for Veltassa, which the company plans to start selling in the first week of January of 2016. With manufacturing in place, a specialty sales force comprising roughly 120 reps in the U.S., the co-detailing partnership with Sanofi SA (ADR) (NYSE: SNY), “and distribution hub for the chronic market, a successful launch is likely,” the report stated.

Wedbush projected peak annual sales to surpass $1 billion in the U.S. alone. Actually, “with FDA approval in hand, we project full year profitability in 2019,” the experts added.

Disclosure: Javier Hasse holds no positions in any of the securities mentioned above.

Latest Ratings for RLYP

DateFirmActionFromTo
Sep 2016BTIGTerminates Coverage OnNeutral
Aug 2016StifelDowngradesBuyHold
Aug 2016OppenheimerTerminates Coverage OnOutperform

View More Analyst Ratings for RLYP

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Posted-In: Analyst Color Biotech Long Ideas Health Care Small Cap Analysis Price Target Reiteration FDA

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