A lawsuit was filed on behalf of investors in Ardelyx, Inc. (NASDAQ:ARDX) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 08/16/2021 -- An investor, who purchased NASDAQ: ARDX shares, filed a lawsuit against Ardelyx, Inc. over alleged violations of Federal Securities Laws.
Investors who purchased shares of Ardelyx, Inc. (NASDAQ: ARDX) have certain options and for certain investors are short and strict deadlines running. Deadline: September 28, 2021. NASDAQ: ARDX investors should contact the Shareholders Foundation at email@example.com or call +1(858) 779 - 1554.
Fremont, CA based Ardelyx, Inc., a biopharmaceutical company, develops and sells medicines for the treatment of kidney and cardiorenal diseases in the United States and internationally.
In June 2020, Ardelyx, Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ("FDA") for its lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with CKD on dialysis. Ardelyx's NDA was purportedly supported by successful Phase 3 studies, which, according to the complaint, showed "improvements" over current treatments and supported tenapanor's "clinical safety and efficacy," reinforcing its "potential" to be a "transformative" treatment.
Ardelyx, Inc. (NASDAQ: ARDX) reported that its annual Total Revenue rose from $5.28 million in 2019 to $7.57 million in 2020, and that its Net loss declined from $94.94 million in 2019 to $94.31 million in 2020.
On July 19, 2021, Ardelyx, Inc announced that it had received a letter from the FDA on July 13, 2021, regarding its New Drug Application for Tenapanor. The FDA was reviewing Tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. In the letter, the FDA stated that it had identified "deficiencies that preclude discussion of labeling and post-marketing requirements/commitments." Ardelyx, Inc said it immediately requested a meeting to discuss the deficiencies but was notified by the FDA that its request for a meeting was denied. Tenapanor was in stage 3 clinical studies.
Shares of Ardelyx, Inc. (NASDAQ: ARDX) declined from $8.24 per share on July 6, 2021, to as low as $1.51 per share on July 26, 2021.
The plaintiff claims that between August 6, 2020 and July 19, 2021, Ardelyx and the other named defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the FDA, which led investors to suffer significant losses.
Those who purchased shares of Ardelyx, Inc. (NASDAQ: ARDX) have certain options and should contact the Shareholders Foundation.
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