Company Update (NASDAQ:RLYP): Relypsa Inc Submits Supplemental New Drug Application to FDA Requesting Label Changes for Veltassa Based on Phase 1 Drug-Drug Interaction Studies

Relypsa Inc (NASDAQ:RLYP), a biopharmaceutical company, today announced that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting label changes for Veltassa® (patiromer) for oral suspension based on results of 12 Phase 1 drug-drug interaction studies in healthy volunteers.

“We were encouraged by the results of our Phase 1 drug-drug interaction studies, which showed no impact to absorption with any of the drugs tested when dosing with Veltassa was separated by 3 hours. In addition, there was no clinically meaningful reduction in absorption for the majority of drugs tested when they were co-administered with Veltassa,” said Lance Berman, M.D., chief medical officer of Relypsa. “We look forward to working with the FDA with the goal of updating Veltassa’s label to reflect these data.” (Original Source)

Shares of Relypsa closed today at $16.19, up $0.26 or 1.63%. RLYP has a 1-year high of $37.45 and a 1-year low of $10.26. The stock’s 50-day moving average is $17.18 and its 200-day moving average is $19.06.

On the ratings front, Relypsa has been the subject of a number of recent research reports. In a report issued on May 23, Morgan Stanley analyst Andrew Berens upgraded RLYP to Hold. Separately, on May 17, Mizuho’s Irina Rivkind Koffler reiterated a Sell rating on the stock and has a price target of $12.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Berens and Irina Rivkind Koffler have a total average return of 12.6% and 26.8% respectively. Berens has a success rate of 69% and is ranked #395 out of 3869 analysts, while Koffler has a success rate of 58% and is ranked #10.

The street is mostly Bullish on RLYP stock. Out of 10 analysts who cover the stock, 8 suggest a Buy rating , one suggests a Sell and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $33.00, which implies an upside of 108.1% from current levels.

Relypsa, Inc. operates as a bio-pharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. Its products include patiromer, a non-absorbed for the treatment of hyperkalemia and RLY6002, polymer drug discovery technology. The company was founded on October 29, 2007 and is headquartered in Redwood City, CA.

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