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
5/2/2025	$11.00	Strong Buy → Outperform	Raymond James
3/7/2025		Buy	Ladenburg Thalmann
3/4/2025	$14.00	Buy	BTIG Research
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

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$ARDX
Press Releases

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Ardelyx to Participate at the Jefferies Global Healthcare Conference 2025
WALTHAM, Mass., May 21, 2025 (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 Mike Raab, President and CEO, will participate in a fireside chat at the Jefferies Global Healthcare Conference 2025 on Wednesday, June 4, 2025 at 8:10 am ET in New York. To access the live webcast of the panel presentation please visit the Events and Presentations page within the Ardelyx website at https://ardelyx.com/. A replay of the fireside chat will be available on the Ardelyx website for 30 days following the event.
5/21/25 8:00:03 AM ET
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Biotechnology: Pharmaceutical Preparations
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Ardelyx Presents Data Supporting IBSRELA® (tenapanor) at Digestive Disease Week 2025 Conference
WALTHAM, Mass., May 06, 2025 (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 the company presented data supporting the company's first-in-class retainagogue, IBSRELA® (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the Digestive Disease Week Conference (DDW), now underway in San Diego. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. "Ardelyx is committed to continuing to grow
5/6/25 8:01:45 AM ET
$ARDX
Biotechnology: Pharmaceutical Preparations
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Ardelyx Reports First Quarter 2025 Financial Results and Provides Business Update
Company reports $74.1 million in Q1 total revenue, reflecting 61% growth year-over-year IBSRELA net product sales revenue of $44.4 million; XPHOZAH net product sales revenue of $23.4 million Company ends Q1 with $214.0 million in cash, cash equivalents and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., May 01, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the first quarter ended March 31, 2025 and provided a business update. "Ardelyx deliver
5/1/25 4:01:51 PM ET
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Biotechnology: Pharmaceutical Preparations
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$ARDX
Leadership Updates

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Ardelyx Appoints Merdad Parsey, M.D., Ph.D. to its Board of Directors
WALTHAM, Mass., April 29, 2025 (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 Merdad Parsey, M.D., Ph.D. to the company's board of directors. "We are thrilled to welcome Merdad to our board of directors," said Mike Raab, president and chief executive officer of Ardelyx. "Merdad is a veteran biotech leader and clinician with a commitment to patients that aligns with the Ardelyx vision of a healthier tomorrow for patients. His broad leadership experience spans the entire pharmaceutical d
4/29/25 8:00:00 AM ET
$ARDX
Biotechnology: Pharmaceutical Preparations
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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
$ARDX
Biotechnology: Pharmaceutical Preparations
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Ardelyx Appoints Veteran BioPharma Executive, Mike Kelliher, as Executive Vice President, Corporate Development and Strategy
WALTHAM, Mass., March 25, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced the appointment of Mike Kelliher to the position of Executive Vice President, Corporate Development and Strategy. Mr. Kelliher, an accomplished leader with more than 20 years of experience in the biopharmaceutical industry, brings to Ardelyx an extensive array of mergers and acquisitions, business development, strategy, finance and operational leadership expertise from leading biotechnology and global pharmaceutical companies.
3/25/24 8:00:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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$ARDX
Financials

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Ardelyx Reports First Quarter 2025 Financial Results and Provides Business Update
Company reports $74.1 million in Q1 total revenue, reflecting 61% growth year-over-year IBSRELA net product sales revenue of $44.4 million; XPHOZAH net product sales revenue of $23.4 million Company ends Q1 with $214.0 million in cash, cash equivalents and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., May 01, 2025 (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 first quarter ended March 31, 2025 and provided a business update. "Ardelyx deliver
5/1/25 4:01:51 PM ET
$ARDX
Biotechnology: Pharmaceutical Preparations
Health Care
Ardelyx to Report First Quarter 2025 Financial Results on May 1, 2025
WALTHAM, Mass., April 17, 2025 (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, May 1, 2025, at 4:30 p.m. Eastern Time to discuss financial results and provide a business update from the first quarter of 2025. 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 Inves
4/17/25 8:00:56 AM ET
$ARDX
Biotechnology: Pharmaceutical Preparations
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Ardelyx Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Company achieved significant commercial progress in 2024, finishing with total revenue of $333.6 million, including $319.2 million in U.S. Net Product Sales Company reaffirms combined peak sales of IBSRELA and XPHOZAH of $1.75 Billion Company ended FY 2024 with $250.1 million in cash, cash equivalents and investments Conference call scheduled for 8:00 AM Eastern Time WALTHAM, Mass., Feb. 20, 2025 (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 fourth quarter and full year ended
2/20/25 7:30:54 AM ET
$ARDX
Biotechnology: Pharmaceutical Preparations
Health Care

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 SEC Filings

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

SEC Form 144 filed by Ardelyx Inc.

SEC Form 10-Q filed by Ardelyx Inc.

$ARDX Press Releases

Fastest customizable press release news feed in the world

Ardelyx to Participate at the Jefferies Global Healthcare Conference 2025

Ardelyx Presents Data Supporting IBSRELA® (tenapanor) at Digestive Disease Week 2025 Conference

Ardelyx Reports First Quarter 2025 Financial Results and Provides Business Update

$ARDX Leadership Updates

Live Leadership Updates

Ardelyx Appoints Merdad Parsey, M.D., Ph.D. to its Board of Directors

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

$ARDX Analyst Ratings

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Ardelyx downgraded by Raymond James with a new price target

Ladenburg Thalmann resumed coverage on Ardelyx

BTIG Research initiated coverage on Ardelyx with a new price target

$ARDX Insider Trading

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

Chief Medical Officer Williams Laura A sold $26,207 worth of shares (6,421 units at $4.08), decreasing direct ownership by 2% to 402,583 units (SEC Form 4)

Chief Financial Officer Renz Justin A sold $29,460 worth of shares (7,218 units at $4.08), decreasing direct ownership by 2% to 416,089 units (SEC Form 4)

President & CEO Raab Michael sold $191,079 worth of shares (46,817 units at $4.08), decreasing direct ownership by 3% to 1,547,937 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

Live finance-specific insights

Ardelyx Reports First Quarter 2025 Financial Results and Provides Business Update

Ardelyx to Report First Quarter 2025 Financial Results on May 1, 2025

Ardelyx Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

$ARDX FDA approvals

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FDA Approval for XPHOZAH issued to ARDELYX INC

FDA Approval for XPHOZAH issued to ARDELYX INC

FDA Approval for XPHOZA™ issued to ARDELYX INC

$ARDX Insider Purchases

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

Director Mott David M bought $329,120 worth of shares (100,000 units at $3.29), increasing direct ownership by 4% to 2,496,871 units (SEC Form 4)

Director Mott David M bought $1,610,936 worth of shares (381,377 units at $4.22), increasing direct ownership by 19% to 2,396,871 units (SEC Form 4)

Director Mott David M bought $388,738 worth of shares (77,729 units at $5.00), increasing direct ownership by 4% to 2,015,494 units (SEC Form 4)

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$ARDX
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Leadership Updates

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Analyst Ratings

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Insider Trading

$ARDX
Large Ownership Changes

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Financials

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FDA approvals

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Insider Purchases