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Ardelyx, Inc. (ARDX)

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Last Post: 9/17/2020 7:08:11 PM - Followers: 5 - Board type: Free - Posts Today: 0

FDA Decision for IBS-C Drug (irritable bowel syndrome with constipation) on September 12, 2019 and Phase 3 readout of the AMPLIFY clinical trial for the treatment of Hyperphosphatemia also in Q3 2019Tenapanor has over $500 million commercial opportunity in each of these indications. ARDX almost trading at cash level which shows how significantly underpriced this company is .

 

Ardelyx (ARDX)

Market-Cap : $155 million
Cash: $124 Million
Price: $2.47



Remaining Expected 2019 Milestones

The company's New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C has a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019.

Results from the AMPLIFY clinical trial, the company's Phase 3 clinical trial evaluating tenapanor's efficacy in combination with phosphate binders, are currently expected to be announced in the third quarter of 2019.


Results from the PHREEDOM clinical trial, the company's second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis, are currently expected to be announced in the fourth quarter of 2019.




5 Biggest New Drug Approvals Potentially on the Way in 2019....August 19, 2019
finance.yahoo.com

5. Tenapanor

Small biotech Ardelyx should be only a few weeks away from some big news. The FDA is scheduled to announce an approval decision for tenapanor in treating irritable bowel syndrome with constipation (IBS-C) by Sept. 12, 2019.

EvaluatePharma expects that the drug could pull in nearly $700 million annually by 2024 if it's approved. Ardelyx hopes that the IBS-C is only the first of two approved indications for tenapanor. The company is also evaluating the drug in a phase 3 clinical study for treating hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis.
Big impacts

FDA approvals for lumateperone and tenapanor would definitely have huge impacts for Intra-Cellular Therapies and Ardelyx. Neither company has an approved product on the market yet.


 


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ARDX News: Statement of Changes in Beneficial Ownership (4) 09/17/2020 06:36:22 PM
ARDX News: Statement of Changes in Beneficial Ownership (4) 09/17/2020 06:35:11 PM
ARDX News: Statement of Changes in Beneficial Ownership (4) 09/17/2020 06:34:20 PM
ARDX News: Statement of Changes in Beneficial Ownership (4) 09/17/2020 06:33:24 PM
ARDX News: Statement of Changes in Beneficial Ownership (4) 09/17/2020 06:32:49 PM
PostSubject
#114   insider selling realfast95 09/17/20 07:08:11 PM
#113   The FDA has set a Prescription Drug User realfast95 09/15/20 08:31:46 AM
#112   decision time realfast95 08/20/20 06:14:40 PM
#111   * * $ARDX Video Chart 02-18-2020 * * ClayTrader 02/18/20 05:43:35 PM
#110   The Normalize trial initial results are promising. Whalatane 12/20/19 09:27:10 AM
#109   Big pharm will step in and buy this HDtexas2003 12/18/19 01:33:17 PM
#108   Eat cheese ;) Just kidding. Glider549 12/16/19 03:34:33 PM
#107   Gilder ..the issue is the following Whalatane 12/16/19 01:45:41 PM
#106   I agree, although the lack of interest is puzzling. Glider549 12/06/19 01:39:27 PM
#105   * * $ARDX Video Chart 12-04-2019 * * ClayTrader 12/04/19 04:57:30 PM
#104   * * $ARDX Video Chart 12-03-2019 * * ClayTrader 12/03/19 05:13:20 PM
#103   https://finance.yahoo.com/news/ardelyx-announces-positive-topline-results-122500 Amatuer17 12/03/19 08:00:30 AM
#102   ARDX news out :) stock1ace1 12/03/19 07:48:15 AM
#101   December 3rd is our big day. Glider549 11/27/19 02:30:13 PM
#100   Correction. Meant Phosphate binders altho Co is working Whalatane 11/27/19 08:28:48 AM
#99   Good pt about potassium binders being main stream. Whalatane 11/26/19 09:31:52 PM
#98   Cara is good - it’s valuation is somewhat Amatuer17 11/26/19 05:41:52 PM
#97   * * $ARDX Video Chart 11-26-2019 * * ClayTrader 11/26/19 05:22:01 PM
#96   New high on good vol . So is Whalatane 11/26/19 03:54:13 PM
#95   Am. Have U looked at CARA Wife’s Whalatane 11/26/19 11:31:17 AM
#94   Agree - it is Monotherapy and if approved Amatuer17 11/26/19 11:05:05 AM
#93   This is what we are waiting for ...from Whalatane 11/26/19 10:49:25 AM
#92   Am. pill burden is huge for those taking Whalatane 11/26/19 10:33:39 AM
#91   Dialysis - pill burden and effects study ARDX drug Amatuer17 11/26/19 07:53:16 AM
#90   * * $ARDX Video Chart 09-13-2019 * * ClayTrader 09/13/19 05:40:10 PM
#89   As expected sale the news. The company cannot do Amatuer17 09/13/19 09:19:11 AM
#88   The box warning is not called black box Amatuer17 09/12/19 07:04:21 PM
#87   Crazy market action . The dehydration Whalatane 09/12/19 05:41:00 PM
#85   Hot FDA News, Corporate News, FDAGet it on dhe777 09/12/19 03:23:19 PM
#84   I am seeing messages that this latest drug dhe777 09/12/19 03:07:59 PM
#83   Did they pass the FDA? PARker1703 09/12/19 02:42:15 PM
#82   News must be out crazy action and a halt. dhe777 09/12/19 02:36:15 PM
#81   Steady up with decent volume last 20 minutes dhe777 09/12/19 12:39:37 PM
#80   Newswire feed for drug related stock information? dhe777 09/12/19 12:03:00 PM
#79   Fda site never announces such news - they Amatuer17 09/12/19 10:58:55 AM
#78   Where do you go for the most immediate dhe777 09/12/19 08:50:39 AM
#77   Today is the day to see the beauty Amatuer17 09/12/19 08:27:56 AM
#76   Anyone holding here? What a beauty ! Eagle1 09/11/19 08:42:35 PM
#75   Not all are but some so yes your right. Dklosinski 09/11/19 06:28:11 PM
#74   Actually most approvals are given ahead of final Amatuer17 09/11/19 07:33:42 AM
#73   What PDUFA has released early? If it needs initsillestform 09/10/19 07:51:16 PM
#72   Actually the decision should have been out by Amatuer17 09/10/19 07:50:56 AM
#71   FDA Decision this Thursday ..ralllyyyyyyyyy could double again easily ADVFN_bioking 09/09/19 11:45:20 AM
#70   ARDX trading activity yielded significant weekly gains. davidsson10 09/06/19 03:38:41 PM
#69   A more detailed analysis ...which I agree with Whalatane 09/04/19 01:59:51 PM
#68   Some random thoughts Whalatane 09/04/19 10:15:32 AM
#67   Some random thoughts Whalatane 09/04/19 10:15:29 AM
#66   lol, he just want to be popular. licnevarez 09/04/19 12:51:19 AM
#65   Happy to be in since 3.10! looking forward initsillestform 09/03/19 11:50:59 PM
#64   Oh lord Clay is here! Tf... He only initsillestform 09/03/19 11:49:18 PM
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