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, Jun. 10, 7:28 AM
- Sarepta Therapeutics (NASDAQ:SRPT) upgraded to Outperform from Neutral by Wedbush. Price target raised to $36 (71% upside) from $14.
- EnteroMedics (NASDAQ:ETRM) downgraded to Neutral from Buy by Roth Capital Partners. Price target is $0.50 (11% upside).
- Relypsa (NASDAQ:RLYP) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target maintained at $9 (52% downside risk).
- Mirati Therapeutics (NASDAQ:MRTX) downgraded to Hold from Buy by Jefferies. Price target lowered to $17 (77% upside) from $27.
- AbbVie (NYSE:ABBV) downgraded to Market Perform from Outperform by Cowen & Company. Price target lowered to $70 (15% upside) from $77. Downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $65 (7% upside) from $73.
- WebMD (NASDAQ:WBMD) downgraded to Market Perform from Outperform by William Blair.
Fri, May 27, 4:56 PM
- Globus Medical (NYSE:GMED) initiated with Equal Weight Rating and $26 (8% upside) price target by Barclays.
- TG Therapeutics (NASDAQ:TGTX) initiated with Buy rating $18 (133% upside) price target by SunTrust Robinson Humphrey.
- Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Outperform rating and $13 (35% upside) price target by Raymond James.
- SAGE Therapeutics (NASDAQ:SAGE) initiated with Sell rating and $18 (43% downside risk) price target by Chardan Capital.
- Viking Therapeutics (NASDAQ:VKTX) initiated with Buy rating with a $5 (285% upside) price target by Maxim Group.
- Fibrocell Science (NASDAQ:FCSC) resumed with Buy rating and $7 (229% upside) price target by Roth Capital Partners.
- Asterias Biotherapeutics (NYSEMKT:AST) initiated with Buy rating and $5.50 (61% upside) price target by Chardan Capital.
- Quorum Health (NYSE:QHC) initiated with Market Perform rating and $14 (6% upside) price target by Avondale Partners.
- Radius Health (NASDAQ:RDUS) initiated with Buy rating and $55 (57% upside) price target by H.C. Wainwright.
- Johnson & Johnson (NYSE:JNJ) initiated with Sell rating and $94 (17% downside risk) price target by Standpoint Research.
- NuVasive (NASDAQ:NUVA) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $63 (15% upside) from $58.
- Zimmer Biomet Holdings (NYSE:ZBH) upgraded to Buy from Hold with a $125 (2% upside) price target by Argus Research.
- Relypsa (NASDAQ:RLYP) upgraded to Equal Weight from Underweight with a $9 (50% downside risk) price target by Morgan Stanley. To be adjusted after ZS-9 rejection.
- Ionis Pharmaceuticals (NASDAQ:IONS) downgraded to Market Perform from Outperform by BMO Capital Markets. Price target lowered to $26 (18% upside) from $55.
- Patterson Companies (NASDAQ:PDCO) downgraded to Hold from Buy by Evercore ISI. Price target lowered to $48.50 (0% upside) from $49.50.
- United Therapeutics (NASDAQ:UTHR) downgraded to Sell from Hold with a $114 (3% downside risk) price target by Argus Research.
- Boston Scientific (NYSE:BSX) downgraded to Neutral from Buy with a $24.20 (7% upside) price target by BTIG Research.
- Neovasc (NASDAQ:NVCN) downgraded to Neutral from Buy by Ladenburg Thalmann. Price target removed.
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.
Wed, May 25, 4:38 PM
- Relypsa (NASDAQ:RLYP) files a supplemental New Drug Application (sNDA) with the FDA seeking a labeling change for hyperkalemia drug Veltassa (patiromer) reducing the current six-hour dose separation requirement from six hours to three. Its filing is based on the results from 12 Phase 1 drug-drug interaction studies which showed no meaningful reduction in absorption for the majority of drugs tested when separated by the shorter time frame.
- Veltassa's package insert currently has a black box warning specifying a minimum separation of six hours between patiromer and oral medications because of the risk of lower absorption of the oral meds caused by binding to patiromer. The six-hour requirement has created headwinds to the company's commercial launch which commenced in December 2015. In a recent survey, 90% of respondents said the requirement would limit their use of the product.
- Previously: Relypsa down 7% premarket as some question Veltassa ramp (May 17)
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
Fri, May 6, 10:32 AM
- Baxter International (BAX -1.1%) initiated with Buy rating and $51 (13% upside) price target by Evercore ISI.
- Intrexon (XON +2.3%) initiated with Market Outperform rating and $42 (62% upside) price target by JMP Securities.
- Heron Therapeutics (HRTX -8.8%) initiated with Buy rating and $41 (143% upside) price target by Cantor Fitzgerald.
- Dr. Reddy's Laboratories (RDY -2.5%) initiated with Neutral rating and Rs.3,334 price target (8% upside) by Goldman Sachs.
- Aeglea BioTherapeutics (AGLE +7.4%) initiated with Buy rating and $12 (33% upside) price target by UBS.
- Cardiome (CRME +34.9%) upgraded to Speculative Buy from Hold by Mackie Research. Price target raised to $8.60 (58% upside) from $5.20.
- Medivation (MDVN +1.2%) upgraded to Buy from Neutral by Citigroup. Price target raised to $73 (22% upside) from $37.
- Masimo (MASI -0.3%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $52 (13% upside) from $43.
- GlaxoSmithKline (GSK -1%) upgraded to Buy from Reduce by Oddo & Cie.
- Cogentix Medical (CGNT -1%) downgraded to Neutral from Buy with a price target of $1.15 (14% upside) by Roth Capital.
- Bruker (BRKR +0.8%) downgraded to Neutral from Outperform by BTIG Research.
- Relypsa (RLYP -4%) downgraded to Underperform from Neutral by Mizuho Securities. Price target cut to $31 (132% upside) from $34.
- Molina Healthcare (MOH -0.7%) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $45 (0% upside) from $75. Downgraded to Neutral from Buy by UBS. Price target lowered to $54 (20% upside) from $76.
- Sarepta Therapeutics (SRPT +1.8%) downgraded to Underperform from Market Perform by Leerink Swann. Price target lowered to $5 (71% downside risk) from $13.
- Sanofi (SNY -0.4%) downgraded to Hold from Buy with an €81 (15% upside) price target by HSBC.
Wed, May 4, 4:19 PM
Wed, May 4, 12:50 PM
Wed, May 4, 9:10 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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