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): July 13, 2021
(Exact name of registrant as specified in its charter)
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Registrant’s telephone number, including area code: (510 ) 745-1700
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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 2.02 Results of Operations and Financial Condition
On July 19, 2021, Ardelyx, Inc. (the “Company”) announced that as of June 30, 2021, the Company had approximately $171.8 million in cash, cash equivalents and short-term investments, which included $28.2 million of net proceeds from sales of common stock under our at-the-market equity facility during the three months ended June 30, 2021. These dollar amounts are unaudited.
The information furnished under this Item 2.02 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Company expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.
Item 8.01 Other Events
On July 19, 2021, the Company announced that it received a letter from the U.S. Food and Drug Administration (the “FDA”) on July 13, 2021 stating that, as part of its ongoing review of the company’s New Drug Application (“NDA”) for the control of serum phosphorus in chronic kidney disease patients on dialysis, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that this notification does not reflect a final decision on the information under review.
While the FDA has not provided specific details regarding the deficiencies, the FDA noted that a key issue is the size of the treatment effect and its clinical relevance. The Company plans to work with the FDA to learn more about the nature of the deficiencies and will seek to resolve them as quickly as possible. In April 2021, the FDA extended the PDUFA date for the NDA to July 29, 2021 as a result of the Company’s submission of additional data analyses requested by the FDA.
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: July 19, 2021 | ARDELYX, INC. | |||||||
| By: | /s/ Elizabeth Grammer | |||||||
| Elizabeth Grammer | ||||||||
| Chief Legal and Administrative Officer | ||||||||