FDA Approval for XPHOZA™ issued to ARDELYX INC

10/18/23 4:37:08 PM ET

$ARDX

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 213931
Company: ARDELYX INC

Products on NDA 213931

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XPHOZA™	TENAPANOR	10MG	TABLET; ORAL	Prescription	None	No	No
XPHOZA™	TENAPANOR	20MG	TABLET; ORAL	Prescription	None	No	No
XPHOZA™	TENAPANOR	30MG	TABLET; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213931

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2023	ORIG-1	Approval	Labeling	STANDARD		Label is not available on this site.

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Recent Analyst Ratings for
$ARDX

Date	Price Target	Rating	Analyst
11/11/2024	$11.00 → $5.50	Buy → Neutral	H.C. Wainwright
7/2/2024	$15.00 → $7.00	Overweight → Neutral	Piper Sandler
4/5/2024	$14.00	Outperform	Leerink Partners
12/18/2023	$12.00	Strong Buy	Raymond James
9/7/2023	$9.00	Buy	H.C. Wainwright
8/25/2023	$5.00 → $10.00	Neutral → Overweight	Cantor Fitzgerald
3/3/2023	$3.00 → $6.00	Neutral → Outperform	Wedbush
11/17/2022	$3.00 → $8.00	Neutral → Overweight	Piper Sandler

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$ARDX
Financials

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Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update
IBSRELA generates $40.6 million in net product sales revenue; Company expects full year 2024 IBSRELA net sales revenue to be between $145 and $150 million XPHOZAH generates $51.5 million in net product sales revenue Company ends Q3 with approximately $190 million in cash, cash equivalents and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- 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 reported financial results for the third quarter ended September 30, 2024 and prov
10/31/24 4:02:40 PM ET
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Ardelyx to Report Third Quarter 2024 Financial Results on October 31, 2024
WALTHAM, Mass., Oct. 17, 2024 (GLOBE NEWSWIRE) -- 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 it will hold a conference call on Thursday, October 31, 2024, at 4:30 p.m. Eastern Time to discuss financial results and provide a business update from the third quarter of 2024. To participate in the conference call, please dial (877) 346-6112 (domestic) or (848) 280-6350 (international) and ask to be joined into the Ardelyx call. Live audio of the conference call will be simultaneously webcast and will be available under the I
10/17/24 8:00:00 AM ET
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Ardelyx Reports Second Quarter 2024 Financial Results and Provides Business Update
IBSRELA generates $35.4 million in net product sales revenue XPHOZAH generates $37.1 million in net product sales revenue Company ends Q2 with approximately $186 million in cash and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., Aug. 01, 2024 (GLOBE NEWSWIRE) -- 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 reported financial results for the second quarter ended June 30, 2024 and provided a business update. "In the second quarter, Ardelyx demonstrated our commitment to our mission and to
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Ardelyx to Participate at the Piper Sandler 36th Annual Healthcare Conference
WALTHAM, Mass., Nov. 20, 2024 (GLOBE NEWSWIRE) -- 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 Justin Renz, Chief Financial and Operations Officer, and Eric Foster, Chief Commercial Officer, will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Wednesday, December 4, 2024 at 12:30pm EST in New York City. To access the live webcast of the panel presentation please visit the Events and Presentations page within the Ardelyx website at https://ir.ardelyx.com/events-and-presentation
11/20/24 8:00:00 AM ET
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Ardelyx Responds to District Court Decision Granting Motion to Dismiss
WALTHAM, Mass., Nov. 08, 2024 (GLOBE NEWSWIRE) -- 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 confirmed that Judge Beryl Howell from the U.S. District Court for Washington, D.C. has granted defendants' motion to dismiss the lawsuit filed by Ardelyx, the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF), permitting the Centers for Medicare and Medicaid Services (CMS) to proceed with its plan to include XPHOZAH® (tenapanor) and other oral-only phosphate lowering therapies (PLTs) in the End-
11/8/24 12:31:21 PM ET
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Ardelyx to Participate at the 2024 Jefferies London Healthcare Conference
WALTHAM, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- 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 Michael Raab, President and CEO, Justin Renz, Chief Financial and Operations Officer and Eric Foster, Chief Commercial Officer, will participate in a fireside chat at the 2024 Jefferies London Healthcare Conference on Tuesday, November 19, 2024 at 12:30pm GMT / 7:30am EST in London. To access the live webcast of the panel presentation please visit the Events and Presentations page within the Ardelyx website at https://ir.ar
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Ardelyx Appoints Experienced Biopharma Executive, Eric Foster, as Chief Commercial Officer
WALTHAM, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- 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 the appointment of Eric Foster as the company's Chief Commercial Officer. Mr. Foster is an experienced leader with more than 23 years of commercial experience for significant global biotech and pharmaceutical companies across numerous complex rare disease and specialty markets. Mr. Foster will be responsible for leading all commercial strategies for the company's two first-in-class medicines, IBSRELA® (tenapanor) and XPHOZAH® (te
8/8/24 8:00:00 AM ET
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Ardelyx Appoints Veteran BioPharma Executive, Mike Kelliher, as Executive Vice President, Corporate Development and Strategy
WALTHAM, Mass., March 25, 2024 (GLOBE NEWSWIRE) -- 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 the appointment of Mike Kelliher to the position of Executive Vice President, Corporate Development and Strategy. Mr. Kelliher, an accomplished leader with more than 20 years of experience in the biopharmaceutical industry, brings to Ardelyx an extensive array of mergers and acquisitions, business development, strategy, finance and operational leadership expertise from leading biotechnology and global pharmaceutical companies.
3/25/24 8:00:00 AM ET
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Intellia Therapeutics Names Muna Bhanji, R.Ph., to its Board of Directors
CAMBRIDGE, Mass., May 02, 2022 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, today announced the appointment of Muna Bhanji, R.Ph., to its board of directors. "We welcome Muna whose deep expertise in global commercialization and market access will be critical to Intellia as we expand our leadership position in the field of genome editing and move closer to commercializing potentially curative treatments for people with life-threatening diseases," said Intellia President and Chief Executive Officer John Leonard, M.D. "We are very fortunate to benef
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Biotechnology: Pharmaceutical Preparations
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Biotechnology: In Vitro & In Vivo Diagnostic Substances
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FDA Approval for XPHOZA™ issued to ARDELYX INC

Products on NDA 213931

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213931

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $ARDX

$ARDX Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

New insider Reilly Joseph James claimed ownership of 120,000 shares (SEC Form 3)

Director Mott David M bought $996,598 worth of shares (215,868 units at $4.62), increasing direct ownership by 18% to 1,425,465 units (SEC Form 4)

President & CEO Raab Michael sold $13,441 worth of shares (2,743 units at $4.90), decreasing direct ownership by 0.23% to 1,207,365 units (SEC Form 4)

$ARDX Large Ownership Changes

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Amendment: SEC Form SC 13G/A filed by Ardelyx Inc.

Amendment: SEC Form SC 13G/A filed by Ardelyx Inc.

SEC Form SC 13G/A filed by Ardelyx Inc. (Amendment)

$ARDX Financials

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$ARDX SEC Filings

FDA Approval for XPHOZAH issued to ARDELYX INC

FDA Approval for XPHOZAH issued to ARDELYX INC

FDA Approval for XPHOZA™ issued to ARDELYX INC

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Ardelyx downgraded by H.C. Wainwright with a new price target

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HC Wainwright & Co. Reiterates Buy on Ardelyx, Maintains $10 Price Target

Ardelyx Files Lawsuit Over Medicare Drug Payment Rules, Claims It Will Limit Patient Access To Kidney Disease Treatment

Wedbush Reiterates Outperform on Ardelyx, Maintains $11 Price Target

Director Mott David M bought $996,598 worth of shares (215,868 units at $4.62), increasing direct ownership by 18% to 1,425,465 units (SEC Form 4)

Ardelyx Inc. filed SEC Form 8-K: Leadership Update, Financial Statements and Exhibits

SEC Form 144 filed by Ardelyx Inc.

SEC Form S-8 filed by Ardelyx Inc.

$ARDX Leadership Updates

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Ardelyx Appoints Experienced Biopharma Executive, Eric Foster, as Chief Commercial Officer

Ardelyx Appoints Veteran BioPharma Executive, Mike Kelliher, as Executive Vice President, Corporate Development and Strategy

Intellia Therapeutics Names Muna Bhanji, R.Ph., to its Board of Directors

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