Relypsa: Unglamorous Niche, Exciting Opportunity
Wed, Jun. 15, 4:19 PM
- In a regulatory filing, Relypsa (NASDAQ:RLYP) reports that retail prescriptions for hyperkalemia drug Veltassa (patiromer) in May were 1,230, up 32.5% from April. New patients who started with a free starter supply totaled 1,385 (+13.9%). Units sold in the hospital/institution setting, however, were down 3.8% (277 in May versus 288 in April).
- The company says the numbers are estimates as they have not been verified by a third party.
- Investors are looking for a healthy ramp considering the company's window of opportunity since competitor AstraZeneca (NYSE:AZN) received a Complete Response Letter (CRL) from the FDA last month regarding its NDA for ZS-9.
- Previously: FDA rejects AstraZeneca's ZS-9 NDA; competitor Relypsa up 29% premarket (May 27)
- Update: Shares are now up 6% on turnover of ~100K.
Fri, May 27, 11:00 AM
Fri, May 27, 9:12 AM
Fri, May 27, 7:25 AM
- In a shot to the corporate solar plexus, AstraZeneca (NYSE:AZN) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of hyperkalemia drug ZS-9 (sodium zirconium cyclosilicate). In a statement, it said the CRL refers to observations from a pre-approval on-site manufacturing inspection. The agency also cited the receipt of recently-submitted data which it has yet to review. The company is reviewing the CRL to determine appropriate action.
- AstraZeneca acquired the rights to ZS-9 via its $2.7B acquisition of ZS Pharma in December 2015.
- Competitor Relypsa (NASDAQ:RLYP) is up 29% premarket on robust volume. Its hyperkalemia drug, Veltassa (patiromer) was approved by the FDA in October 2015.
- AstraZeneca is down 1% premarket on increased volume.
Mon, May 23, 9:16 AM
Mon, May 23, 8:58 AM
- Relypsa (NASDAQ:RLYP) is up 5% premarket on light volume in response to the announcement new data supporting the efficacy of hyperkalemia med Veltassa (patiromer) oral suspension. The results were presented at the 53rd Congress of the European Renal Association - European Dialysis and Transplant Association in Vienna, Austria.
- Results from a Phase 1 study, RLY5016-101, in 32 healthy volunteers who received daily doses of up to 50.4 grams of Veltassa for eight days showed a statistically significant dose-related decrease in mean urine sodium compared to placebo (p=0.009).
- A post-hoc analysis from a Phase 2 trial, AMETHYST-DN, in hyperkalemic patients with chronic kidney disease and type 2 diabetes who were taking certain anti-hypertension drugs showed mean blood potassium decreased significantly from baseline to day 3 after treatment with Veltassa in those with mild-to-moderate hyperkalemia (excess serum potassium). In addition, patients receiving Veltassa maintained clinically significant decreases in mean blood potassium for a year. The incidence of adverse events (AEs) was 23% with the most common being constipation (8.9%) and diarrhea (5.4%). The rate of discontinuations due to AEs was 8.9%.
- Veltassa was approved by the FDA in October 2015.
Tue, May 17, 9:20 AM
Tue, May 17, 9:09 AM
- Relypsa (NASDAQ:RLYP) slumps 7% premarket on increased volume in apparent response to chatter that Veltassa (patiromer) sales will continue to under-impress (sales were $0.6M in Q1). Citigroup cut its price target on the stock to $25 from $30.
- Update: A survey of 112 nephrologists conducted by Zug, Switzerland-based Spherix Global Insights revealed that more than half of the Veltassa user base is in the trial mode. The majority expect to increase their use of Veltassa in the near term, although the six-hour dose separation requirement is the leading disadvantage with 90% of the respondents saying it will (at least somewhat) limit their use of the product. The feedback is largely consistent with what was provided by cardiologists (n=93), although they are less familiar with Veltassa.
- Commercialization partner Vifor Fresenius Medical Care Renal Pharma Ltd. filed a Marketing Authorization Application (MAA) with the European Medicines Agency several weeks ago seeking approval to sell Veltassa in the EU.
- Relypsa is neck-and-neck with AstraZeneca (AZN +0.2%) and its hyperkalemia drug ZS-9. Regulatory applications are under review in both the U.S. and Europe. The FDA's action date is May 26. Veltassa was approved in the U.S. in October 2015 and launched two months later.
Mon, May 16, 5:39 PM
Wed, May 4, 12:50 PM
Wed, May 4, 9:10 AM
Tue, May 3, 5:37 PM
Tue, May 3, 4:35 PM
- Relypsa (NASDAQ:RLYP) slumps 13% after hours on increased volume in response to its announcement that it has closed a $150M offering of senior secured term loans bearing an interest rate of 11.5% per annum. The loans mature on April 27, 2022 and include a 30-month interest-only provision that can be extended to 48 months under certain conditions.
- Net proceeds will fund the repayment of outstanding borrowings (~$17M) under its loan and security agreement with Oxford Finance LLC and Silicon Valley Bank, the ongoing commercialization of Veltassa in the U.S., working capital and general corporate purposes.
Thu, Apr. 21, 12:48 PM
Fri, Apr. 15, 12:41 PM
Fri, Apr. 15, 9:13 AM
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... More
Country: United States
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