Ardelyx files $250M mixed securities shelf 06:4407/0907/09/20
|Over a week ago|
Ardelyx submits NDA to FDA for tenapanor » 08:0306/3006/30/20
Ardelyx announced the…
Ardelyx announced the submission of a New Drug Application for tenapanor to the U.S. FDA for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. Based on standard FDA review timelines, the company expects to receive notification from the FDA on the acceptance of the filing for substantive review in late August.
Fly Insider: Epizyme,DraftKings among week's notable insider transactions » 12:3906/2906/29/20
AVGO, SSSS, AESE, DKNG, AMSWA, CATM, RPTX, EPZM, ARDX, APLT
Welcome to "Fly Insider,"…
Ardelyx reports 'positive' data from ongoing NORMALIZE study » 08:0406/1506/15/20
Ardelyx reported positive…
Ardelyx reported positive data from its ongoing NORMALIZE study, which is designed to evaluate the ability of tenapanor, as monotherapy or in combination with sevelamer, to achieve serum phosphorus levels in the normal range in patients with chronic kidney disease on dialysis. Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor which, if approved, will provide a completely new approach for the control of serum phosphorus in patients with CKD on dialysis, blocking the absorption of phosphorus at the primary pathway of uptake. "These data from the NORMALIZE study are unprecedented in terms of the proportion of patients able to achieve serum phosphorus levels less than 4.6mg/dL with foundational use of tenapanor," said Stuart Sprague DO, FASN, chief of the Division of Nephrology and Hypertension at Northshore University Health System. "This represents an important advancement in the management of hyperphosphatemia for patients on dialysis. The ability of tenapanor to drive phosphorus levels closer to normal has the potential to completely change the hyperphosphatemia treatment paradigm." The NORMALIZE extension study allowed patients from PHREEDOM, the positive Phase 3 long-term monotherapy study, to continue therapy with tenapanor, and enabled those in the safety control arm receiving sevelamer, to transition to tenapanor. The planned second analysis demonstrated that the foundational use of tenapanor as monotherapy or in combination with sevelamer carbonate produces a significant phosphorus-lowering effect with a mean serum phosphorous reduction of 2.33 mg/dL, from a mean baseline phosphorus of 7.27 mg/dL at the beginning of the PHREEDOM trial to a mean of 4.94 mg/dL at the time of this analysis. Of the 171 patients in this interim analysis who completed up to 9 months of treatment in this extension study, up to 47.4% achieved a normal serum phosphorus level, and of those, the majority were on tenapanor alone or tenapanor with low dose sevelamer of less than or equal to3 sevelamer tablets per day. These data represent a 58% improvement in the rate of patients who achieve a normal serum phosphorus level, as compared to current treatment practice data as reported in the April 2020 Dialysis Outcomes Practice Patterns Study Practice Monitor. The DOPPS data demonstrate that, with current standard of care treatment of phosphate binders alone, only 30% of patients have serum phosphorous levels less than 4.6 mg/dL. The only adverse event reported in greater than5% of patients in NORMALIZE was diarrhea, with an incidence rate of 23.3%.
|Over a month ago|
Ardelyx names Justin Renz as CFO » 16:0306/0806/08/20
Ardelyx announced the…
Ardelyx announced the appointment of Justin Renz to the position of CFO. Renz brings an extensive array of financial and operational experience to Ardelyx. He most recently served as the president and CFO of Correvio Pharma.
Ardelyx appoints Susan Rodriguez Chief Commercial Officer » 16:0205/1805/18/20
Ardelyx announced the…
Ardelyx announced the appointment of Susan Rodriguez, an industry veteran with over 25 years of global pharmaceutical experience, as the company's first Chief Commercial Officer. Rodriguez will be responsible for leading the commercial organization, including launch planning and strategy, as well as alliance management and business development. Previously, Rodriguez served as the founding CEO of Tolmar Pharmaceuticals, a U.S. commercial entity of marketed products, that was later merged with sister companies where she served as president of the branded division.
Ardelyx reports Q1 EPS (25c), consensus (25c) » 16:3905/0705/07/20
Reports Q1 revenue $1.2M,…
Reports Q1 revenue $1.2M, consensus $550K. Mike Raab, CEO, stated, "We are fortunate that much of our clinical work has been completed, with minimal impact of the pandemic on our business, and we are on track to submit our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis by mid-year. In preparation for potential approval in mid-2021, we are laying the foundation for launch with important pre-commercial activities underway."
Knight Therapeutics announces approval of IBSRELA in Canada » 07:3904/1704/17/20
Knight Therapeutics announced that Health Canada has approved IBSRELA for the treatment of irritable bowel syndrome with constipation in adults. Knight and Ardelyx signed an agreement in March 2018 granting Knight the exclusive right to distribute IBSRELA in Canada for IBS-C and hyperphosphatemia. IBSRELA is a minimally-absorbed small molecule that acts locally in the gastrointestinal tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients. On September 12, 2019, the U.S. Food and Drug Administration approved IBSRELA for the treatment of irritable bowel syndrome with constipation in adults.
|Over a quarter ago|
Piper has 'meaningfully higher' conviction in Ardelyx after management calls » 05:1804/0904/09/20
After hosting virtual…
After hosting virtual investor meetings with management this week, Piper Sandler analyst Christopher Raymond's conviction in favorite small-cap pick Ardelyx is "meaningfully higher." The stock's current valuation continues to reflect a "massive" disconnect between physician sentiment regarding tenapanor's renal opportunity and that of the Street, Raymond tells investors in a research note. When coupled with the fact that there is essentially zero COVID-19-related impact to tenapanor's timelines, or management's planned commercial preparedness activities, there is "compelling value with this name," adds the analyst. Raymond recommends buying shares of Ardelyx to levels approaching $15 and keeps an Overweight rating on the shares.
Ardelyx remains a top pick after 'quiet' Q4 at Piper Sandler » 05:3303/0903/09/20
Piper Sandler analyst…
Piper Sandler analyst Christopher Raymond says Ardelyx remains a top pick following the company's "quiet" Q4 update. Last Friday's earnings report was uneventful, but the shares can work as investors become increasingly aware of what physicians have been saying for some time: that tenapanor is likely to be one of the biggest renal launches in history, Raymond tells investors in a research note. The analyst keeps an Overweight rating on Ardelyx with a $15 price target.