UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 4, 2022
(Exact name of registrant as specified in its charter)
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
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Item 8.01 Other Events.
On February 4, 2022, the Company received an Appeal Denied Letter (“ADL”) from the Office of Cardiology, Hematology, Endocrinology and Nephrology (“OCHEN”) of the U.S. Food and Drug Administration (the “FDA”) in response to its Formal Dispute Resolution Request (“FDRR”) submitted in early December 2021, and following its submission on January 7, 2022, of additional clarifying data requested by OCHEN. The Company intends to appeal the ADL to the Office of New Drugs (“OND”), Center for Drug Evaluation and Research. If accepted for consideration, the Company expects a decision on the appeal to the OND in April 2022.
The Company submitted the FDRR in response to the Complete Response Letter (“CRL”) the Company received on July 28, 2021, regarding its New Drug Application (“NDA”) for the control of serum phosphorus in chronic kidney disease patients on dialysis. The FDRR was focused on demonstrating that the data submitted in the NDA supported the clinical significance of the treatment effect of tenapanor. The CRL noted that in order for the NDA to be approved, the Company needs to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect on serum phosphorus or an effect on the clinical outcome thought to be caused by hyperphosphatemia in CKD patients on dialysis. The ADL provided the Company a potential additional path forward involving the resubmission of the NDA (without conducting an additional trial) with a number of new analyses of each of the Company’s Phase 3 clinical trials; an assessment of tenapanor’s benefits and risks; and a proposal of how to label tenapanor for prescribers.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | ||||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | ||||||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: February 9, 2022 | ARDELYX, INC. | |||||||
| By: | /s/ Justin Renz | |||||||
| Justin Renz | ||||||||
| Chief Financial Officer | ||||||||