Category: ARDX

ARDX – SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Ardelyx, Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of September 28, 2021 – ARDX

New York, New York–(Newsfile Corp. – August 22, 2021) – The following statement is being issued by Levi & Korsinsky, LLP:

To: All persons or entities who purchased or otherwise acquired securities of Ardelyx, Inc. (“Ardelyx”) (NASDAQ: ARDX) between August 6, 2020 and July 19, 2021. You are hereby notified that a securities class action lawsuit has been commenced in the United States District Court for the Northern District of California. To get more information go to:

https://www.zlk.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18816&wire=5

or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500. There is no cost or obligation to you.

Cannot view this image? Visit: https://www.elitestockchat.com/wp-content/uploads/2021/08/94035_664806_logo.jpg

Ardelyx, Inc. NEWS – ARDX NEWS

CASE DETAILS: According to the filed complaint: 1) the Company overstated the likelihood that tenapanor would be approved by the Food and Drug Administration (“FDA”); and 2) Defendants possessed, were in control over, and as a result, knew that the data submitted to support the New Drug Application was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely that the FDA would not approve the drug.

WHAT THIS MEANS TO SHAREHOLDERS: If you suffered a loss in Ardelyx, you have until September 28, 2021 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.

NO COST TO YOU: If you purchased Ardelyx securities between August 6, 2020 and July 19, 2021, you may be entitled to compensation without payment of any out-of-pocket costs or fees.

PROTECT YOUR FINANCIAL INTERESTS: Complete this brief submission form https://www.zlk.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18816&wire=5 or call 212-363-7500 to discuss the case with Joseph E. Levi, Esq.

WHY LEVI & KORSINSKY: Levi & Korsinsky have a proven track record of winning cases worth hundreds of millions of dollars for shareholders over a 20-year period. We represent and fight for shareholders who have been wronged by corporations.

Levi & Korsinsky is a nationally recognized firm with offices in New York, California, Connecticut, and Washington, D.C. The Firm’s Founding Partners, Joseph Levi and Eduard Korsinsky, have been representing shareholders and institutional clients for almost 20 years and have achieved remarkable results for clients in the U.S. and internationally. The firm, with more than 80 employees, is committed to fostering, cultivating and preserving a culture of diversity, equity and inclusion for employees and those that we represent. Our attorneys have extensive expertise representing investors in securities litigation with a track record of recovering hundreds of millions of dollars in cases. Levi & Korsinsky was ranked in Institutional Shareholder Services’ (“ISS”) SCAS Top 50 Report for 7 years in a row as a top securities litigation firm in the United States. The SCAS Top 50 Report identifies the top plaintiffs’ securities law firms in the country, and year after year, ISS has recognized Levi & Korsinsky as a leading firm in the area of securities class action litigation.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
55 Broadway, 10th Floor
New York, NY 10006
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
www.zlk.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/94035

info

ARDX – Rosen, Trusted Investor Counsel, Encourages Ardelyx, Inc. Investors with Losses to Secure Counsel Before Important Deadline in Securities Class Action – ARDX

New York, New York–(Newsfile Corp. – August 21, 2021) – WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Ardelyx, Inc. (NASDAQ: ARDX) between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”) of the important September 28, 2021 lead plaintiff deadline.

SO WHAT: If you purchased Ardelyx securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Ardelyx class action, go to http://www.rosenlegal.com/cases-register-2134.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 28, 2021. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made materially false and misleading statements regarding Ardelyx’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with chronic kidney disease (“CKD”) on dialysis and the likelihood that it would be approved by the U.S. Food and Drug Administration (“FDA”). Specifically, the lawsuit alleges that defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support the New Drug Application was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely (if not certain) that the FDA would not approve the drug. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Ardelyx class action, go to http://www.rosenlegal.com/cases-register-2134.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

——————————-

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93899

info

ARDX – ARDX LAWSUIT: The Law Offices of Vincent Wong Notify Investors of a Class Action Lawsuit Involving Ardelyx, Inc.

New York, New York–(Newsfile Corp. – August 19, 2021) – The Law Offices of Vincent Wong announce that a class action lawsuit has commenced in the on behalf of investors who purchased Ardelyx, Inc. (“Ardelyx”) (NASDAQ: ARDX) between August 6, 2020 and July 19, 2021.

If you suffered a loss, contact us at the link below. There is no cost or obligation to you.
https://www.wongesq.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18739&wire=5

Cannot view this image? Visit: https://www.elitestockchat.com/wp-content/uploads/2021/08/93814_942340_logo.jpg

Allegations against ARDX include that the Company made materially false and/or misleading statements and/or failed to disclose that: 1) the Company overstated the likelihood that tenapanor would be approved by the Food and Drug Administration (“FDA”); and 2) Defendants possessed, were in control over, and as a result, knew that the data submitted to support the New Drug Application was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely that the FDA would not approve the drug.

If you suffered a loss in Ardelyx you have until September 28, 2021 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.

Vincent Wong, Esq. is an experienced attorney that has represented investors in securities litigations involving financial fraud and violations of shareholder rights. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Vincent Wong, Esq.
39 East Broadway
Suite 304
New York, NY 10002
Tel. 212.425.1140
Fax. 866.699.3880
E-Mail: vw@wongesq.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93814

info

ARDX – SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Ardelyx, Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of September 28, 2021 – ARDX

New York, New York–(Newsfile Corp. – August 17, 2021) – The following statement is being issued by Levi & Korsinsky, LLP:

To: All persons or entities who purchased or otherwise acquired securities of Ardelyx, Inc. (“Ardelyx”) (NASDAQ: ARDX) between August 6, 2020 and July 19, 2021. You are hereby notified that a securities class action lawsuit has been commenced in the United States District Court for the Northern District of California. To get more information go to:

https://www.zlk.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18652&wire=5

or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500. There is no cost or obligation to you.

Cannot view this image? Visit: https://www.elitestockchat.com/wp-content/uploads/2021/08/93537_821876_logo.jpg

Ardelyx, Inc. NEWS – ARDX NEWS

CASE DETAILS: According to the filed complaint: 1) the Company overstated the likelihood that tenapanor would be approved by the Food and Drug Administration (“FDA”); and 2) Defendants possessed, were in control over, and as a result, knew that the data submitted to support the New Drug Application was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely that the FDA would not approve the drug.

WHAT THIS MEANS TO SHAREHOLDERS: If you suffered a loss in Ardelyx, you have until September 28, 2021 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.

NO COST TO YOU: If you purchased Ardelyx securities between August 6, 2020 and July 19, 2021, you may be entitled to compensation without payment of any out-of-pocket costs or fees.

PROTECT YOUR FINANCIAL INTERESTS: Complete this brief submission form https://www.zlk.com/pslra-1/ardelyx-inc-loss-submission-form?prid=18652&wire=5 or call 212-363-7500 to discuss the case with Joseph E. Levi, Esq.

WHY LEVI & KORSINSKY: Levi & Korsinsky have a proven track record of winning cases worth hundreds of millions of dollars for shareholders over a 20-year period. We represent and fight for shareholders who have been wronged by corporations.

Levi & Korsinsky is a nationally recognized firm with offices in New York, California, Connecticut, and Washington, D.C. The Firm’s Founding Partners, Joseph Levi and Eduard Korsinsky, have been representing shareholders and institutional clients for almost 20 years and have achieved remarkable results for clients in the U.S. and internationally. The firm, with more than 80 employees, is committed to fostering, cultivating and preserving a culture of diversity, equity and inclusion for employees and those that we represent. Our attorneys have extensive expertise representing investors in securities litigation with a track record of recovering hundreds of millions of dollars in cases. Levi & Korsinsky was ranked in Institutional Shareholder Services’ (“ISS”) SCAS Top 50 Report for 7 years in a row as a top securities litigation firm in the United States. The SCAS Top 50 Report identifies the top plaintiffs’ securities law firms in the country, and year after year, ISS has recognized Levi & Korsinsky as a leading firm in the area of securities class action litigation.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
55 Broadway, 10th Floor
New York, NY 10006
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
www.zlk.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93537

info

ARDX – SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Ardelyx, Inc. of Class Action Lawsuit and Upcoming Deadline – ARDX

New York, New York–(Newsfile Corp. – August 17, 2021) –  Pomerantz LLP announces that a class action lawsuit has been filed against Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX) and certain of its officers. The class action was filed in the United States District Court for the Northern District of California, Oakland Division, and docketed under 21-cv-06228. Plaintiff brings this federal securities class action under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and U.S. Securities and Exchange Commission Rule 10b-5 promulgated thereunder, 17 C.F.R. § 240.10b-5, on behalf of a class consisting of all persons and entities, other than Defendants and their affiliates, who purchased Ardelyx securities between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”), and who were damaged thereby (the “Class”).

If you are a shareholder who purchased or otherwise acquired Ardelyx securities during the Class Period, you have until September 28, 2021 to ask the Court to appoint you as Lead Plaintiff for the Class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.

[Click here for information about joining the class action]

Ardelyx is a specialized biopharmaceutical company focused on developing first-in-class medicine to improve treatment for people with cardiorenal disease. This includes patients with chronic kidney disease (“CKD”) on dialysis suffering from elevated serum phosphorus, or hyperphosphatemia; and CKD patients and/or heart failure patients with elevated serum potassium, or hyperkalemia.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the U.S. Food and Drug Administration (“FDA”). Defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support a New Drug Application (“NDA”) for tenapanor was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely (if not certain) that the FDA would not approve the drug.

In June 2020, Defendants submitted an NDA to the FDA for Ardelyx’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with CKD on dialysis. According to Ardelyx, tenapanor has “a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3, or NHE3,” resulting in the “tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption.” If approved, tenapanor “would be the first therapy for phosphate management that blocks phosphorus absorption at the primary pathway of uptake[,]” and “could greatly improve patient adherence and compliance with one single pill dosed twice daily in contrast to current therapies where typically multiple pills are taken before every meal.” Thus, tenapanor (and its promise) was widely touted by Defendants and, accordingly, extremely important to the valuation (and future success) of Ardelyx securities.

The FDA accepted Ardelyx’s NDA in September 2020 and set a Prescription Drug User Fee Act (“PDUFA”) date of April 29, 2021.

The Company repeatedly lauded this development, highlighting the FDA’s acceptance and review of the NDA, supported by so-called “successful” Phase 3 studies, in each subsequently filed quarterly report and in the Company’s 2020 annual report. Even when the FDA requested that the Company provide additional information related to Ardelyx’s clinical data, which caused the PDUFA date to slip by three months, Defendants continued to hype Ardelyx’s “positive” clinical trial results, which, according to them, showed “improvements” over current treatments, supported tenapanor’s “clinical safety and efficacy,” and reinforced its “potential” as a “transformative” treatment. At no point did Defendants state (much less suggest) that there may be fatal issues with the drug, its clinical trial data, or both. Rather, Defendants simply claimed that the FDA’s request was merely because they needed help to “better understand the clinical data in light of tenapanor’s novel mechanism of action as compared to approved therapies.”

Defendants’ rosy narrative, however, came to a halt after the market closed on July 19, 2021. At that time, Ardelyx announced that it had received a letter from the FDA, dated July 13, 2021, that said the administration had found deficiencies that precluded discussion around the would-be labeling and post-marketing requirements for tenapanor. Critically, the FDA said it detected issues with both the size and clinical relevance of the drug’s treatment effect.

Immediately, analysts cut their price targets and downgraded the Company’s rating. Piper Sandler, for example, rated Ardelyx neutral (down from a buy-equivalent rating) and wrote, “we struggle to see a path forward for Tenapanor.” Raymond James, another analyst, reset the Company’s price target to $4.00 from $14.00 per share.

The Company’s share price likewise plummeted, falling $5.69 per share, or nearly 74%, in a single day, to close at $2.01 per share on July 20, 2021, before falling another 4.2% by market close on July 21, 2021.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/93487

info

ARDX – Ardelyx (ARDX) Reports Q2 Loss, Tops Revenue Estimates

Ardelyx (ARDX Free Report) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.36. This compares to loss of $0.28 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of -25%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.32 per share when it actually produced a loss of $0.34, delivering a surprise of -6.25%.

Over the last four quarters, the company has surpassed consensus EPS estimates just once.

Ardelyx, which belongs to the Zacks Medical – Drugs industry, posted revenues of $1.31 million for the quarter ended June 2021, surpassing the Zacks Consensus Estimate by 19.36%. This compares to year-ago revenues of $1.84 million. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock’s immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management’s commentary on the earnings call.

Ardelyx shares have lost about 76.5% since the beginning of the year versus the S&P 500’s gain of 18.8%.

What’s Next for Ardelyx?

While Ardelyx has underperformed the market so far this year, the question that comes to investors’ minds is: what’s next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company’s earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Ardelyx was mixed. While the magnitude and direction of estimate revisions could change following the company’s just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.29 on $1.1 million in revenues for the coming quarter and -$1.32 on $8.79 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical – Drugs is currently in the bottom 17% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

ARDX – Pomerantz Law Firm Announces the Filing of a Class Action Against Ardelyx, Inc. and Certain Officers – ARDX

NEW YORK, Aug. 12, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX) and certain of its officers.   The class action was filed in the United States District Court for the Northern District of California, Oakland Division, and docketed under 21-cv-06228.  Plaintiff brings this federal securities class action under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and U.S. Securities and Exchange Commission Rule 10b-5 promulgated thereunder, 17 C.F.R. § 240.10b-5, on behalf of a class consisting of all persons and entities, other than Defendants and their affiliates, who purchased Ardelyx securities between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”), and who were damaged thereby (the “Class”).

If you are a shareholder who purchased or otherwise acquired Ardelyx securities during the Class Period, you have until September 28, 2021 to ask the Court to appoint you as Lead Plaintiff for the Class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980.  Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Ardelyx is a specialized biopharmaceutical company focused on developing first-in-class medicine to improve treatment for people with cardiorenal disease.  This includes patients with chronic kidney disease (“CKD”) on dialysis suffering from elevated serum phosphorus, or hyperphosphatemia; and CKD patients and/or heart failure patients with elevated serum potassium, or hyperkalemia.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the U.S. Food and Drug Administration (“FDA”).  Defendants possessed, were in control over, and, as a result, knew (or had reason to know) that the data submitted to support a New Drug Application (“NDA”) for tenapanor was insufficient in that it showed a lack of clinical relevance of the drug’s treatment effect, making it foreseeably likely (if not certain) that the FDA would not approve the drug.

In June 2020, Defendants submitted an NDA to the FDA for Ardelyx’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with CKD on dialysis.  According to Ardelyx, tenapanor has “a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3, or NHE3,” resulting in the “tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption.”  If approved, tenapanor “would be the first therapy for phosphate management that blocks phosphorus absorption at the primary pathway of uptake[,]” and “could greatly improve patient adherence and compliance with one single pill dosed twice daily in contrast to current therapies where typically multiple pills are taken before every meal.”  Thus, tenapanor (and its promise) was widely touted by Defendants and, accordingly, extremely important to the valuation (and future success) of Ardelyx securities.

The FDA accepted Ardelyx’s NDA in September 2020 and set a Prescription Drug User Fee Act (“PDUFA”) date of April 29, 2021.

The Company repeatedly lauded this development, highlighting the FDA’s acceptance and review of the NDA, supported by so-called “successful” Phase 3 studies, in each subsequently filed quarterly report and in the Company’s 2020 annual report.  Even when the FDA requested that the Company provide additional information related to Ardelyx’s clinical data, which caused the PDUFA date to slip by three months, Defendants continued to hype Ardelyx’s “positive” clinical trial results, which, according to them, showed “improvements” over current treatments, supported tenapanor’s “clinical safety and efficacy,” and reinforced its “potential” as a “transformative” treatment.  At no point did Defendants state (much less suggest) that there may be fatal issues with the drug, its clinical trial data, or both.  Rather, Defendants simply claimed that the FDA’s request was merely because they needed help to “better understand the clinical data in light of tenapanor’s novel mechanism of action as compared to approved therapies.”

Defendants’ rosy narrative, however, came to a halt after the market closed on July 19, 2021.  At that time, Ardelyx announced that it had received a letter from the FDA, dated July 13, 2021, that said the administration had found deficiencies that precluded discussion around the would-be labeling and post-marketing requirements for tenapanor.  Critically, the FDA said it detected issues with both the size and clinical relevance of the drug’s treatment effect.

Immediately, analysts cut their price targets and downgraded the Company’s rating.  Piper Sandler, for example, rated Ardelyx neutral (down from a buy-equivalent rating) and wrote, “we struggle to see a path forward for Tenapanor.”  Raymond James, another analyst, reset the Company’s price target to $4.00 from $14.00 per share.

The Company’s share price likewise plummeted, falling $5.69 per share, or nearly 74%, in a single day, to close at $2.01 per share on July 20, 2021, before falling another 4.2% by market close on July 21, 2021.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

CONTACT:

Robert S. Willoughby

Pomerantz LLP

[email protected]

888-476-6529 ext. 7980

SOURCE Pomerantz LLP

Related Links

www.pomerantzlaw.com

ARDX – INVESTOR ACTION REMINDER: The Schall Law Firm Reminds Investors of a Class Action Lawsuit Against Ardelyx, Inc. and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm

Los Angeles, California–(Newsfile Corp. – August 6, 2021) – The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Ardelyx, Inc. (“Ardelyx” or “the Company”) (NASDAQ: ARDX) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Investors who purchased the Company’s securities between August 6, 2020 and July 19, 2021, inclusive (the ”Class Period”), are encouraged to contact the firm before September 28, 2021.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm’s website at www.schallfirm.com, or by email at brian@schallfirm.com.

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

According to the Complaint, the Company made false and misleading statements to the market. Ardelyx knew or had reason to know that the data it submitted to the FDA as part of the New Drug Application (“NDA”) for tenapanor was insufficient. The Company’s NDA demonstrated a lack of clinical relevance for the drug’s treatment effect. Based on these facts, the Company’s public statements were false and materially misleading throughout the class period. When the market learned the truth about Ardelyx, investors suffered damages.

Join the case to recover your losses.

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

CONTACT:

The Schall Law Firm
Brian Schall, Esq.,
www.schallfirm.com
Office: 310-301-3335
info@schallfirm.com

SOURCE:

The Schall Law Firm

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/92352

info

  • 1
  • 2