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Ardelyx, Inc. (ARDX)

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Last Post: 7/27/2021 4:42:38 PM - Followers: 24 - Board type: Free - Posts Today: 20

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: Is There an Opportunity in Ardelyx Stock After Massive Selloff? Analyst Weighs In 07/21/2021 04:52:34 PM
ARDX News: Hot Stocks: Earnings move IBM, HCA, PPG; FDA decisions prompt gains in AMRX, steep losses in ARDX 07/20/2021 09:06:33 AM
ARDX News: Ardelyx downgraded on Wall Street after setback for kidney disease drug 07/20/2021 07:10:19 AM
ARDX News: Current Report Filing (8-k) 07/19/2021 04:24:37 PM
ARDX News: FDA flags deficiencies in Ardelyx's kidney disease treatment NDA 07/19/2021 04:08:37 PM
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#346   Probably wise to set a high sell around Johnstonj27 07/27/21 04:42:38 PM
#345   Slim chance FDA being real difficult these days. Johnstonj27 07/27/21 04:40:53 PM
#344   It could be any notice of possible approval LINK Oracle 07/27/21 03:21:46 PM
#343   Imagine by small chance what an FDA approval Johnstonj27 07/27/21 12:26:36 PM
#342   Bring on the Reversal.... SQUEEZE Johnstonj27 07/27/21 12:25:57 PM
#341   Shorting this low not the smartest move... Johnstonj27 07/27/21 12:25:35 PM
#340   ARDX 5 day 10min chart looks like reversal Nebuchadnezzar 07/27/21 11:57:10 AM
#339   $2.50-$3 LFG.... Johnstonj27 07/27/21 11:51:50 AM
#338   1.66 GETTING SMACKED !!!! 1plus1 07/27/21 11:45:04 AM
#337   Squeeze Tight Johnstonj27 07/27/21 11:03:06 AM
#336   She’ll give ya what ya want after a Hattori Hanzo 07/27/21 11:00:21 AM
#335   Think Wall Street just figured out the opportunity Johnstonj27 07/27/21 10:56:39 AM
#334   Showtime..... Johnstonj27 07/27/21 10:55:15 AM
#333   Added more 1.53 Send it $3.00 ++++ Johnstonj27 07/27/21 10:50:18 AM
#332   and `monitor still works softballdaddy 07/27/21 10:36:15 AM
#331   Y’all had to jinks it… BAWHAHAHA DR. EVIL 07/27/21 10:20:41 AM
#330   Thanks for posting that, i was concerned my softballdaddy 07/27/21 10:03:53 AM
#329   It's Green... Johnstonj27 07/27/21 09:58:16 AM
#328   Have to slap myself first and check... Johnstonj27 07/27/21 09:57:49 AM
#327   green? is it real? lol Nebuchadnezzar 07/27/21 09:57:07 AM
#326   ARDX is now officially a LOTTO PLAY and Nebuchadnezzar 07/26/21 04:30:31 PM
#325   all things bounce unless they get delisted. Nebuchadnezzar 07/26/21 03:27:24 PM
#324   From filing report last Monday softballdaddy 07/26/21 02:29:19 PM
#323   I Know, but days away from that FDA Johnstonj27 07/26/21 11:05:37 AM
#322   ARDX $1.55--we have to be close to a bottom Nebuchadnezzar 07/26/21 11:04:52 AM
#321   excellent question! even DIDI is effing green now Nebuchadnezzar 07/26/21 09:56:18 AM
#320   Wow, never thought would end up a bag Johnstonj27 07/26/21 09:51:44 AM
#319   I will be happy with $2.10-$2.25 Nebuchadnezzar 07/25/21 12:52:36 AM
#318   ARDX- 5 year monthly chart Nebuchadnezzar 07/24/21 07:20:03 PM
#317   I really hope this company gets bought out. ASK 07/24/21 06:46:49 PM
#316   Going Green.... Can't stop Adding........ THAT RSI is Johnstonj27 07/23/21 03:16:56 PM
#315   next week should be fun >>> locked heavy 1plus1 07/23/21 03:09:06 PM
#314   picking up another 20k @ 1.67 1plus1 07/23/21 03:06:46 PM
#313   Look,, just dropped this buy order for 200 Johnstonj27 07/23/21 02:38:54 PM
#312   Look at the bid right now 407,800 shares Johnstonj27 07/23/21 02:23:05 PM
#311   I agree would love to see an audit Johnstonj27 07/23/21 02:21:38 PM
#310   AI trading algorithm that executes orders and manipulates Cosa 07/23/21 01:52:56 PM
#309   Yeah, got to pop at some point hard Johnstonj27 07/23/21 01:02:25 PM
#308   volume drying up a little. perhaps the selling Nebuchadnezzar 07/23/21 12:59:32 PM
#307   I hope so - I think the drug jerseyboy 07/23/21 12:58:03 PM
#306   Not worried... this company will figure it all out... Johnstonj27 07/23/21 12:56:43 PM
#305   Hopefully other regulatory agencies around the world will jerseyboy 07/23/21 12:52:52 PM
#304   World Market... buddy. Johnstonj27 07/23/21 10:11:50 AM
#303   Thank God I got rid of this before jerseyboy 07/23/21 09:51:17 AM
#302   hopefully a dead cat bounce and not a softballdaddy 07/22/21 08:01:02 PM
#301   I got in on this one under $2. Shockerj 07/22/21 06:34:13 PM
#300   Right now the exact same scenario playing out Johnstonj27 07/22/21 05:49:58 PM
#299   What keeps this not moving up? RSI Johnstonj27 07/22/21 05:44:35 PM
#298   Too many times my stuff just get's crushed Johnstonj27 07/22/21 05:35:29 PM
#297   I think you're right about phantom/synthetic shares. Cosa 07/22/21 05:22:52 PM
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