FDA denies Ardelyx's appeal against kidney drug rejection, hammering another nail in tenapanor's coffin By Nick Paul TaylorFeb 10, 2022 09:36am The next milestone for Ardelyx is penciled in for April, when it expects to learn OND’s decision about its latest appeal. ( syahrir maulana/iStock/Getty Images Plus) The FDA has deflated Ardelyx's attempt to recover quickly from a complete response letter. With Ardelyx looking to sidestep a request for another trial, the FDA held its ground and denied the appeal—leaving the biotech looking to a Hail Mary pass to overturn the decision. Ardelyx's woes date back to last summer, when the FDA raised concerns with the evidence submitted to support approval of chronic kidney disease (CKD) drug tenapanor. The FDA agreed Ardelyx had found the drug, which inhibits the sodium-proton exchanger NHE3, reduces serum phosphorus in CKD patients on dialysis, but deemed the treatment effect to be “small and of unclear clinical significance.” Facing a request for an additional “adequate and well-controlled trial,” Ardelyx laid off 65% of its staff and filed a Formal Dispute Resolution Request with the Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN). The FDA office responded with an appeal denied letter (ADL). Ardelyx plans to respond to the denial by escalating the matter. Having failed to persuade OCHEN of the merits of its case, Ardelyx is preparing to appeal the ADL to the Office of New Drugs (OND). The FDA’s appeal process allows companies to go up the chain of command step by step, culminating in a request for the commissioner to review the matter. The next milestone for Ardelyx is penciled in for April, when it expects to learn OND’s decision about its latest appeal. If successful, Ardelyx could refile for approval without running an additional study. Ardelyx is proposing to include new analyses of existing phase 3 results, as well as an assessment of the benefits and risks of tenapanor and a proposal for how to label the drug. Another rejection will leave Ardelyx in a sticky situation. Ardelyx ended September with $142 million in the bank, a sum it sought to eke out by laying off 65% of its staff. The biotech burned through $47 million over the first nine months of last year.
After 2 rejections, FDA panel rallies around Ardelyx's kidney disease prospect Nov 17, 2022 08:05am Following a positive vote at Wednesday's advisory committee meeting, Ardelyx CEO Mike Raab said the company is "optimistic" about an upcoming approval appeal on tenapanor. (Ardelyx) Upon weathering a pair of surprise kidney disease snubs this year and last, Ardelyx managed to wrangle a high-stakes FDA hearing to present its case for NHE3 inhibitor tenapanor. Wednesday, the medicine’s judgment day arrived. And, after roughly eight hours of deliberation, tenapanor seems to have gained some regulatory ground. After hearing the case for—and against—the drug's application to control serum phosphorous in adults with chronic kidney disease (CKD) on dialysis, nine members of the FDA’s Cardiovascular and Renal Drug Advisory Committee voted in favor of Ardelyx’s drug. The remaining four panelists voted against tenapanor’s use as a monotherapy. When the prospect of combining tenapanor with the current standard of care for hyperphosphatemia—phosphate binders—was raised, the panel of experts was even more optimistic: 10 members of the advisory committee voted yes, with only two nos and one abstention. In CKD patients, hyperphosphatemia refers to a buildup of serum phosphorous, which can cause blood calcium levels to drop, potentially leading to muscle cramps or spasms, rashes, bone and joint pain and more. Following the positive vote, the FDA’s Office of New Drugs is expected to respond to Ardelyx’s approval appeal by mid-December, the company said in a release.The agency first rejected Ardelyx's drug last summer and did so again in February. Tenapanor is already approved as Ibsrela in irritable bowel syndrome (IBS), though it would carry a different name if cleared to control phosphate levels in CKD patients. One panelist, C. Noel Bairey Merz, M.D., of Cedars-Sinai Medical Center in Los Angeles, endorsed tenapanor alone and in tandem with phosphate binders. She reasoned there’s a large number of patients who are "unable or unwilling to take the standard of care right now.” CKD patients trying to manage their phosphorous levels with phosphate binders must take a surfeit of meds. Ardelyx estimates those patients take a median of 19 pills each day. Aside from the inconvenience of current status quo therapy, some 42% of patients on phosphate binders fail to adequately control their condition in any given month, the company estimates. Over a six-month stretch, that proportion of patients rises to 77%. “The current status quo is not tenable,” added another voting member, Paul Conway of the American Association of Kidney Patients. Overall, the yay-sayers on the advisory committee generally agreed tenapanor would provide doctors and patients with another useful tool to control serum phosphorous. While the med’s benefit may not be huge, it carries a convenience edge over phosphate binders and is largely safe enough not to raise concerns. A tenepanor approval as either a monotherapy or in combination with binders "would be a win for patients," Ardelyx CEO Mike Raab said over email. He added that the company will "continue to seek the broadest label we can for Xphozah," referring to the candidate by its proposed commercial name. Some experts still harbor doubts, however. Take Javed Butler, M.D., of the University of Mississippi and the Baylor Scott and White Research Institute, who issued a “reluctant” yes in response to both voting questions. Citing an “acceptable” safety profile, Butler said the bigger issue at play is “this field probably deserves a higher bar for efficacy.” At the same time, he noted that the data on tenapanor “[meet] the precedent of what has been done previously in this area.” He agreed with other panelists that only a “small subset” of CKD patients would benefit from a tenapanor monotherapy, but he figures patients deserve another option regardless. On the flip side, tenapanor’s “modest” efficacy informed the monotherapy no vote from the Inova Heart and Vascular Institute’s Christopher O’Connor, M.D. The expert took issue with Ardelyx’s trial design and suggested the company run another study. Still, it now looks "highly unlikely" that Ardelyx will need to run additional studies before it can reapply at the FDA, the company's CEO Raab added. He caveated that Ardelyx "won't have complete certainty until after we receive a response from the Office of New Drugs." Ardelyx has been working hard to redeem its drug after an initial rejection last summer, which came as a shock to both analysts and the company. Ardelyx’s therapy received another rejection in February after the company appealed its complete response letter from the FDA. Undiscouraged, the fledgling commercial player moved to summon an advisory committee, and its request was granted in April. As recently as Monday, the FDA seemed to be telegraphing yet another dismissal of the med. Now, in light of Wednesday’s decision, Ardelyx is more determined than ever to see tenapanor through to the serum phosphorous finish line. "We are really pleased," Raab said. "Our mission was to clearly communicate our data, and we believe we succeeded with that." Tenapanor's next test will come in December, where Raab foresees at least two "potential favorable" outcomes on its regulatory appeal. "First, if the appeal is granted, the NDA resubmission would likely take us directly to labeling discussions with the FDA," he explained. The second scenario would see the appeal denied but "with a clear path forward articulated in the letter" from the Office of New Drugs, Raab said. “We are confident that the data from three phase 3 clinical trials involving more than 1,200 patients support the approval of Xphozah in the U.S. for the control of serum phosphorus in adult patients with CKD on dialysis,” the CEO noted. Editor's note: This story was updated with comments from Ardelyx CEO Mike Raab.
https://www.bafirm.com/wp-content/uploads/2015/10/Millennium-Labs-Faces-Medicare-Whistleblower-Retaliation-Suit-FINAL.pdf $240 MM for the Whistleblowers and Government in settlement of drug testing claims - Ryan Uehling.
Ardelyx, Inc. (ARDX) - 1586490 After the companies receives a response from the OMD, things will move forward. If the "Appeal Granted" is accepted, the PFDUA date could be 2 months or 6 months later.
Ardelyx, Inc. Reports Employment Inducement Grants WALTHAM, Mass., Dec. 23, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that on December 16, 2022, the compensation committee of the company's board of directors granted 17 new non-executive employees options to purchase an aggregate of 271,735 shares of the company's common stock, and an aggregate of 123,375 Restricted Stock Units (RSUs). Each stock option has an exercise price per share equal to $1.96 per share, which was the closing trading price of the company's common stock on the date of grant. The stock options and RSUs were granted as inducements material to each employee's decision to enter into employment with Ardelyx, in accordance with Nasdaq Listing Rule 5635(c)(4). Each stock option vests over four years, with 25% of the shares vesting on the first anniversary of the employee's first date of employment, and the remaining 75% of shares vesting monthly thereafter. Each RSU vests over four years, with 25% vesting on the first company designated quarterly RSU vest date following the first anniversary of the employee's first day of employment, and the remaining 75% of shares vesting quarterly thereafter. Each stock option has a 10-year term, and each option and RSU is subject to the terms and conditions of the company's 2016 Employment Commencement Incentive Plan and the award agreement covering the grant.
This launch will fail because the “leadership” is a group of amateurs. No experience, look at LI profiles, all have been recently promoted from outside industry or rep roles. The head of sales Dan isn’t listed on LI but heard from two “directors” he wants to retire. Inexperience shows with disorganized hiring process. I talked to others and heard ranges of 7-10 interviews being held by current reps to multiple managers to others who weren’t familiar with sales launches. This isn’t sour grapes as I’ve removed myself. Pay seems to be high but unless you’re desperate, I think the lack of urgency, disorganization and lack of experience spell doom. I was personally asked 2 interview questions I know you can’t ask and heard similar from another person interviewing. This will go into the bundle in a year and yet no urgency. When I asked what will happen if not approved, or when it goes into bundle, I got a variety of answers from different interviewers - from I don’t know, to you’ll be rolled into GI, to some should be absorbed by GI, but not sure how they would be prioritized. Good luck if you decide to hang in there, I’m staying where I’m at.
With Susan Rodriguez in charge of commercial, Sharon Funk in charge of marketing and Dan Pavicich in charge of sales, you should be winning jk jk jk all you have is industry rejects
