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Ardelyx Inc

Ardelyx Inc (ARDX)

3.55
-0.11
(-3.01%)
3.57
0.02
(0.56%)

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Key stats and details

Current Price
3.57
Bid
3.55
Ask
3.62
Volume
2,648,516
3.54 Day's Range 3.67
3.21 52 Week Range 8.06
Market Cap
Previous Close
3.66
Open
3.64
Last Trade Time
Financial Volume
$ 9,482,604
VWAP
3.5803
Average Volume (3m)
5,760,685
Shares Outstanding
239,255,212
Dividend Yield
-
PE Ratio
-21.64
Earnings Per Share (EPS)
-0.16
Revenue
333.62M
Net Profit
-39.14M

About Ardelyx Inc

Ardelyx Inc is a biotechnology company focused on the discovery, development, and commercialization of molecule and polymeric therapeutics to treat the gastrointestinal tract and cardiorenal diseases. The company has a proprietary drug discovery and design platform. Its lead product candidate is ten... Ardelyx Inc is a biotechnology company focused on the discovery, development, and commercialization of molecule and polymeric therapeutics to treat the gastrointestinal tract and cardiorenal diseases. The company has a proprietary drug discovery and design platform. Its lead product candidate is tenapanor, which aims to reduce the absorption of dietary sodium and phosphorus for the treatment of kidney disease, irritable bowel syndrome with constipation, and hyperphosphatemia in patients with dialysis. Show more

Sector
Pharmaceutical Preparations
Industry
Pharmaceutical Preparations
Website
Headquarters
Camden, Delaware, USA
Founded
-
Ardelyx Inc is listed in the Pharmaceutical Preparations sector of the NASDAQ with ticker ARDX. The last closing price for Ardelyx was $3.66. Over the last year, Ardelyx shares have traded in a share price range of $ 3.21 to $ 8.06.

Ardelyx currently has 239,255,212 shares outstanding. The market capitalization of Ardelyx is $875.67 million. Ardelyx has a price to earnings ratio (PE ratio) of -21.64.

ARDX Latest News

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.19-5.053191489363.763.883.54555933583.68483778CS
4-0.56-13.55932203394.134.26993.54547677113.79987296CS
12-1.67-31.87022900765.245.6453.2157606854.24862399CS
26-1.7795-33.2647911025.34956.553.2149262034.70977295CS
52-2.74-43.42313787646.318.063.2144797445.19913388CS
1563.0599599.8627720050.510110.130.510256268864.44936523CS
260-3.21-47.34513274346.7810.130.490252630183.6181996CS

ARDX - Frequently Asked Questions (FAQ)

What is the current Ardelyx share price?
The current share price of Ardelyx is $ 3.57
How many Ardelyx shares are in issue?
Ardelyx has 239,255,212 shares in issue
What is the market cap of Ardelyx?
The market capitalisation of Ardelyx is USD 875.67M
What is the 1 year trading range for Ardelyx share price?
Ardelyx has traded in the range of $ 3.21 to $ 8.06 during the past year
What is the PE ratio of Ardelyx?
The price to earnings ratio of Ardelyx is -21.64
What is the cash to sales ratio of Ardelyx?
The cash to sales ratio of Ardelyx is 2.54
What is the reporting currency for Ardelyx?
Ardelyx reports financial results in USD
What is the latest annual turnover for Ardelyx?
The latest annual turnover of Ardelyx is USD 333.62M
What is the latest annual profit for Ardelyx?
The latest annual profit of Ardelyx is USD -39.14M
What is the registered address of Ardelyx?
The registered address for Ardelyx is 2140 S DUPONT HWY, KENT, CAMDEN, DELAWARE, 19934
What is the Ardelyx website address?
The website address for Ardelyx is www.ardelyx.com
Which industry sector does Ardelyx operate in?
Ardelyx operates in the PHARMACEUTICAL PREPARATIONS sector

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ARDX Discussion

View Posts
rosemountbomber rosemountbomber 2 weeks ago
The stock had stopped dropping and firmed up over the last 2 weeks, but then Friday a big drop relatively speaking.  Wonder if that might be related to traders realizing UNCY approval would be negative for ARDX.  I may keep some ARDX as a hedge in case UNCY does not get approval.  Why is Mott buying?
๐Ÿ‘๏ธ0
Whalatane Whalatane 2 weeks ago
RMB. I may bail on ARDX as UNCY's OLC PDUFA date nears . I'd really like to know what Motts plan is .
Here we are going into June and no progress that I'm aware of getting Medicare coverage renewed for Xphozah .
The info I have on the TDAPA process is that if ARDX was to apply for TDAPA , they would have full coverage for 2-3 yrs and then 50% coverage for 3 yrs after that. . Thats a huge chunk of $ they aren't getting right now
Once UNCY's OLC is approved , they will immediately apply for TDAPA and have OLC on the market by end of year .
I can't see Mott doing nothing and just allowing UNCY to be the only new pho binder covered for Medicare patients .

Kiwi
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Whalatane Whalatane 2 weeks ago
RMB. I may bail on ARDX as UNCY's OLC PDUFA date nears . I'd really like to know what Motts plan is .
Here we are going into June and no progress that I'm aware of getting Medicare coverage renewed for Xphozah .
The info I have on the TDAPA process is that if ARDX was to apply for TDAPA , they would have full coverage for 2-3 yrs and then 50% coverage for 3 yrs after that. . Thats a huge chunk of $ they aren't getting right now
Once UNCY's OLC is approved , they will immediately apply for TDAPA and have OLC on the market by end of year .
I can't see Mott doing nothing and just allowing UNCY to be the only new pho binder covered for Medicare patients .

Kiwi
๐Ÿ‘๏ธ0
rosemountbomber rosemountbomber 4 weeks ago
If the price goes 20% below your purchase price, Mott, who currently has a full head of hair, will pull each and every one of them out!
👍️ 1
Whalatane Whalatane 4 weeks ago
yep Mott's still buying ...latest reported today
http://archive.fast-edgar.com/20250519/AWZ7322COM22UJ9Z222N2ZZ2R4K2Z22IZ272/

Lets hope he has a plan .
I'm holding to see what happens . But if it goes 20% below my purchase price , I'll be stopped out
Kiwi
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rosemountbomber rosemountbomber 4 weeks ago
Well stock price approaching area I had originally thought of dumping.  But seeing that Mott continues buy has made me sit tight for the moment
๐Ÿ‘๏ธ0
Whalatane Whalatane 1 month ago
I was stopped out at $4 on the way down .
Just bt back a small position to follow at $3.7
Reasons
Mott has been buying on the open market .
Theres still an EU deal out there
Mott may make a deal with CMS
Interest in other indications

Kiwi
๐Ÿ‘๏ธ0
Whalatane Whalatane 1 month ago
There might be a paper out on using Xphozah / IBSRELA in Parkinson patients who have problems with constipation
Constipation is a common non-motor symptom in Parkinsonโ€™s disease, affecting up to 70% of patients. It results from slowed gastrointestinal motility due to autonomic dysfunction and degeneration of enteric nervous system neurons, often predating motor symptoms.

Theres also this https://clinicaltrials.gov/study/NCT06481150?term=NCT06481150&rank=1&tab=history&a=2&b=3#version-content-panel

UNCY ...13F data out
Kiwi
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rosemountbomber rosemountbomber 1 month ago
Nice move this morning.  If there is anything behind it, we peons will be last to know
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Whalatane Whalatane 1 month ago
RMB. Congrats on the tech trades . Maybe more on ARDX and UNCY tonight as I have a date right now with my sewer line excavation project :--(
Hopefully you or anyone reading this, never has to do a sewer line replacement ...at least not in a hilly wooded area .

Kiwi
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rosemountbomber rosemountbomber 1 month ago
Thanks Kiwi. I wasn't thinking about the ramifications to ARDX from an UNCY approval. Since the time I woke up in my own bed Monday morning, it has been a whirlwind of things that I have been catching up on. Hopefully, there is some dead cat bounce in the stock where I can unload or at least lighten up.

Looking back over the last two days being home it has been a bit nuts. On my trip I decided that as soon as I got home I would take my RMD as soon as I got home. Kept thinking about all kinds of things on the cruise and began to worry that if something happened to me that my son/wife would miss the fact that my first RMD needed to be taken this year and whether death affects that or not, but I think it would still need to be taken. I know it typically makes more sense to take it late in the year so as to keep as much of the earnings sheltered.

Have to say (not bragging as you are well aware of the many stock disasters I have endured), but before leaving on the cruise in mid-April I scooped up a bunch of various tech/AI stocks and yesterday started to take profits. They can still go up but when I make that much so quickly, at my age, I need to harvest. (You know the old story about a frog into boiling water vs a frog in room temp water and then heated until boiling). Slow and steady rise I would still be holding but these parabolic moves have me running for the hills. As I told my wife the calendar may work differently this year but typically sell in May and buy in October, so we can do this again in a few months.

I have to say that if you did tell me your PLTR story, my aging brain has let it escape from its engrams. There are a number of stocks that I held in the past and got frustrated with either no movement or downside and I can think of names like PLTR, UPST, etc that I could have made a ton if I had just held on another year or two. Be interested to hear the PLTR story of yours.
๐Ÿ‘๏ธ0
Whalatane Whalatane 1 month ago
Actually here's a thought for U .
Mott should buy UNCY and work out a deal as follows .
Take Xphozah in the morning ...creates a "looser " stool which patients like ( makes them feel normal ) ...but only 1 dose a day so reduces risk of diarrhea .
Take UNCY's OLC for the remainder of the day ( or only at night ) ..less risk of nausea.

They have done studies with this combo ...patients like it ...best of both worlds to lower serum pho .

Would / could it actually happen ... probably not the way our healthcare system works
Kiwi
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Whalatane Whalatane 1 month ago
Cahones :--) So if UNCY's OLC gets approved on June 28th ..and Mott hasn't worked a deal with CMS by then ...what happens to ARDX ?
Xphozah is 2 small pills a day ...with major issues with diarrhea for some ( wife has patients stop using it for this reason ) ..OLC is 3 small pills a day ( no diarrhea but more nausea than with Xphozah
Kiwi
PS. Did I ever tell you about PLTR back in 2023 :--)
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rosemountbomber rosemountbomber 1 month ago
After earnings I decided that I was going to bail on the first uptick over $4.  That was last week.  Now looking at it, although not going up it seems to be stabilizing and stopping the slide, not to mention the continuous buying by Mott.  So today I actually added
๐Ÿ‘๏ธ0
Whalatane Whalatane 1 month ago
Hi Cosa. I no longer own the stock but I do note that the Chairman of the Board ...Mott. is still buying like crazy on the open market

1. Name and Address of Reporting Person *
MOTT DAVID M
(Last) (First) (Middle)
C/O ARDELYX, INC.
400 FIFTH AVENUE, SUITE 210
(Street)
WALTHAM MA 02451
(City) (State) (Zip)
2. Issuer Name and Ticker or Trading Symbol
ARDELYX, INC. [ ARDX ] 5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)
X Director 10% Owner
Officer (give title below) Other (specify below)
3. Date of Earliest Transaction (Month/Day/Year)
05/02/2025
4. If Amendment, Date of Original Filed (Month/Day/Year)
6. Individual or Joint/Group Filing (Check Applicable Line)
X Form filed by One Reporting Person
Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1. Title of Security (Instr. 3) 2. Transaction Date (Month/Day/Year) 2A. Deemed Execution Date, if any (Month/Day/Year) 3. Transaction Code (Instr. 8) 4. Securities Acquired (A) or Disposed Of (D) (Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 05/02/2025 P 381,377 A $ 4.224 (1) 2,396,871 (2) D
Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
(e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date (Month/Day/Year) 7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4) 8. Price of Derivative Security (Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Explanation of Responses:
1. Transaction was executed in multiple trades in prices ranging from $3.745 to $4.54, inclusive. The price reported in Column 4 above reflects the weighted average sale price. The Reporting Person hereby undertakes to provide to the Securities and Exchange Commission staff, the Issuer, or a security holder of the Issuer, upon request, full information regarding the number of shares sold at each respective price within the range set forth in this footnote
2. The Reporting Person holds 87,566 shares for the benefit of entities associated with New Enterprise Associates and disclaims beneficial ownership of such shares, except to the extent of his actual pecuniary interest therein.
/s/ Elizabeth Grammer, Attorney-in-Fact for David Mott 05/05/2025

That is a $1.6m open market purchase !!!!!

Kiwi
👍️ 1
Cosa Cosa 1 month ago
The only good thing is Ardelyx Assist gets patients Xphozah for $0, which is a blessing for those people in need. But it also translates to $0 for shareholders lol.
๐Ÿ‘๏ธ0
ErnieBilco ErnieBilco 1 month ago
They generally come to me eventually, will this one hit my $2 mark? Who knows but I set it there in december and see no reason to move it.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175468036
๐Ÿ‘๏ธ0
Whalatane Whalatane 1 month ago
Thx ..yes IBSRELA is fine ...the problem is XPHOZAH and the lack of Medicare coverage ....and no progress YTD in resolving that .
Kiwi
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aBeezlee aBeezlee 1 month ago
It doesn't sound horrible to me:

"Positive Points
Ardelyx Inc (NASDAQ:ARDX) reported a significant revenue growth of 61% year-over-year, reaching $74 million in the first quarter of 2025.

IBSRELA showed a 57% increase in net sales revenue compared to the previous year, indicating strong demand and market penetration.

XPHOZAH achieved a 30% revenue growth year-over-year, excluding one-time adjustments, demonstrating its importance in managing phosphorus levels for patients.

The company reaffirmed its 2025 guidance of $240 million to $250 million in net sales for IBSRELA, with a clear path to achieving over $1 billion in peak annual net sales.

Ardelyx Inc (NASDAQ:ARDX) maintained a strong cash position with $214 million in cash, cash equivalents, and short-term investments as of March 31, 2025, supporting its ongoing operations and strategic initiatives.

Negative Points
The loss of Medicare Part D coverage for phosphate-lowering therapies has caused significant disruption in the dialysis market, affecting XPHOZAH's market dynamics.

The company experienced a net loss of approximately $41.1 million in the first quarter, compared to a net loss of $26.5 million in the same period last year.

Research and development expenses increased to $14.9 million, reflecting higher engagement with scientific and medical communities.

Selling, general, and administrative expenses rose to $83.2 million, up from $53 million in the prior year, due to expanded commercial activities and corporate infrastructure growth.

Ardelyx Inc (NASDAQ:ARDX) has not yet provided formal revenue guidance for XPHOZAH due to the fluid market environment and ongoing access complexities."
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Whalatane Whalatane 1 month ago
Haven't followed it closely lately but did the Ibsrela sales disappoint ?

I think Mott is still buying on the open market ...so hopefully he has a plan some where ...like a deal for the EU market
Good luck
Kiwi
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aBeezlee aBeezlee 1 month ago
You were lucky! It's under $4 now...
๐Ÿ‘๏ธ0
Whalatane Whalatane 2 months ago
Yep ...out of my position a month ago .
In the renal space chk UNCY ..pdufa date June 28 , and VERA with important data in Q2
Kiwi
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Cosa Cosa 2 months ago
That was a terrible Q1!! negative quarter over quarter. Not good...
๐Ÿ‘๏ธ0
Cosa Cosa 3 months ago
That's when I'll be buying more lol.
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Whalatane Whalatane 3 months ago
As long as DOGE and Kennedy dominate CMS spending ...its tough for me to see them willing to pay for Xphozah at the current price ARDX is charging .
I'll probably stop loss my position at around $4 and just let it play out , one way or the other
Kiwi
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rosemountbomber rosemountbomber 3 months ago
Thanks for catching and posting.  Now it is a question of if and when votes can be scheduled.  We came so clise with the KPA last year and didn't get it over the finish line it is difficult to raise hopes too soon here.  We shall see
๐Ÿ‘๏ธ0
Whalatane Whalatane 3 months ago
https://kidneycarepartners.org/press/house-reintroduction-of-the-restore-protections-for-dialysis-patients-act-commended-by-kidney-community/
Considered positive for ARDX
The bill ensures dialysis patients can continue receiving the life-sustaining care they need without disruption by maintaining access to private insurance coverage for the full 30-month coordination period before transitioning to Medicare as their primary payer.
Kiwi
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Cosa Cosa 3 months ago
IMO It should be extended for the life of patent until generics are available.

The patient should have access to whatever drug works best for them. Whether itโ€™s a binder or blocker. The government is over stepping their boundaries from political lobbying in favor of companies to profit. Rather than letting professional rheumatologists and nephrologist do whatโ€™s best.
👍️ 1
Cosa Cosa 3 months ago
As much as you are correct in your assessment, depending on politicians is not a great business strategy.

100%
Itโ€™s the revenue growth that is making me bullish here. They did $300M+ in 2024. They crushed all analyst predictions. With the CMS bs, need to see Q1 numbers to see how much revenue growth slows down. Ironically Xphozah started out pacing Ibsrela out the gate but last quarter showed strong Ibsrela growth. Which could be off label subscriptions as Kiwi brought up.
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Whalatane Whalatane 3 months ago
Cosa. I agree that drug Co's must be incentivized to develop new drugs .
One win win is for ARDX to lower the price of XPHOZAH and the CMS to extend the TDAPA time line so that the Co recoups their costs and hopefully makes some $ .

Binders vs blockers
Patients dont care .
All they care about is
1) does it work and can I tolerate it
2) is it available and can I afford the copay

Kiwi
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rosemountbomber rosemountbomber 3 months ago
Cosa - "So politicians need to fix it" - you said a mouthful there.  Were you following the Kidney Patient Act last year? So many sponsors and so many groups lobbying for it and they couldn't get it across ghe finish line last year. 

As much as you are correct in your assessment, depending on politicians is not a great business strategy.  
👍️ 1
Cosa Cosa 3 months ago
Its not a great deal if you have spent millions running clinical trials for use in dialysis patients ...thats why they are fighting it .

Exactly... So politicians need to fix it. They're causing the lack of access to new drugs.

The price is fair for the newest FDA approved drug for that condition. It doesn't matter if it is the same drug, they spent millions of dollars on trials and studies to get it there. If these studies were not done, no one would know it could be used for that.

They need to fight the fight or new drug discoveries is done. Do you think there will be new studies for lowering serum pho another company stands to lose millions of dollars? No. This will be the last FDA approved drug if that's the case. ARDX is in a position of strength. There will be no new discoveries.

OLC is still a phosphate binder. Xphozah is not a binder it is a blocker. Big difference.
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Whalatane Whalatane 3 months ago
The current TDAPA process works roughly as follows . For the first usually 2.5 yrs ( at least 2 yrs ) ARDX gets full price for Xphozah . For the following 2-3 yrs the price paid gets tapered down closer to existing generics .
Its not a great deal if you have spent millions running clinical trials for use in dialysis patients ...thats why they are fighting it .

If they do nothing ....are unable to get a comprise from DMS such as extending the TDAPA process or simply refuse to start the current TDAPA process...they lose the Medicare dialysis patient population almost completely . Medicare dialysis patients are roughly 60% if the total dialysis population.

ARDX can lower the cost of Xphozah ( its way over priced compared to IBSREA which is the same drug just different dose ) in exchange for an extended TDAPA process . Amgen ? did this years ago with Repatha ....cutting the price roughly in half in exchange for wider access.

If it was up to patients ...based on the feedback I get . The ideal combination is one Xphozah pill in the morning and one OLC pill at night .
OLC is the most effective at lowering serum pho but some nausea at full dose .
Xphozah at full dose causes many to experience diarrhea ....half dose it relieves the constipation many of these dialysis patients complain of ...but little to no nausea.

Meanwhile ...if you can't get Medicare to cover you for Xphozah , get your Nephrologist to write you a script for IBSRELA with a pill cutter . Take half of 1 pill in the am and the other half in the pm and save everyone a lot of $.
Of course ARDX would be selling a lot less Xphozah ...but IBSRELA scripts will jump ( however ARDX would make less $ then if it was full priced Xphozah )

Kiwi
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Cosa Cosa 3 months ago
How is this good?

Once TDAPA ends and the drug is incorporated into the bundle without a rate adjustment, facilities may have financial incentives to limit use of costlier new drugs
๐Ÿ‘๏ธ0
Whalatane Whalatane 3 months ago
ARDX /Mott. needs to make a deal with CMS to get Xphozah covered for Medicare dialysis patients . Right now they aren't getting $ for these patients ...unless they are in their Assist program ...which may mean ARDX if giving Xphozah for almost free just to keep them on X .
So if ARDX does not make a deal with CMS , refuses to go into the TDAPA program as its currently designed ...they will have wasted millions of $ on this drug which never reaches roughly 60% of the dialysis patients that could use it .

CMS could just wait them out . Which appears their current strategy . ARDX / Mott eventual cave , start the existing TDAPA process ...and lose the income they would have received already if they had started TDAPA when scheduled.

Kiwi
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Cosa Cosa 3 months ago
Revenue will also send this higher. Q1 numbers in May will be important.
๐Ÿ‘๏ธ0
Whalatane Whalatane 4 months ago
Mott keeps buying in the open market ...main reason I keep my small position .
Any deal with CMS will send this significantly higher .
A small select group of patients ...those that have serious constipation problems ...love Xphozah for serum pho control ...so there is a small well defined market of Medicare patients

Kiwi
👍 1
rosemountbomber rosemountbomber 4 months ago
Basically increases shares owned by 50% in one fell swoop.  Not much shame.  Lowering my target on this.  I am sort of thinking of this investment as partially a binary coupling with UNCY.  If UNCY is successful and steals sales from ARDX it will be like a hedge for me. 
๐Ÿ‘๏ธ0
Whalatane Whalatane 4 months ago
Holy sh#t ...the RSU's these guys award themselves
http://archive.fast-edgar.com/20250227/AMZZC62CO2228ZBZ2M2O2ZZ2RG5AZ22IZ472/
These vest over 48 mths ...even at $5 a share ...do the math !!!!

At least the Chairman of the Board Mott is still buying in the open market

Kiwi
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Whalatane Whalatane 4 months ago
Hi RMB. I think it's up to their Chinese partner to get govt reimbursement lined up and the drug launched . ARDX will only receive royalty payments when /if that happens .
Pressing issue is Xphozah and Medicare patients / CMS stance .
Currently Medicare dialysis patients aren't covered so Co is providing an Assist program ...Dont know how well thats used or even if Co breakevens even on it .
CMS ( JFK jnr ? ) will probably play hard ball .
Why pay extra for Xphozah when the same drug in IBSRELA form is so much cheaper .
If they at least started the TDAPA process they would get full payment for at least 2 yrs ....maybe 2.5 yrs ...and then a decline in reimbursement for the following 3 yrs .
Right now ARDX gets nothing from the CMS / Medicare dialysis patients beyond their assist program ( which may actual cost them or be break even )
Meanwhile UNCY is on track for its June approval of OLC ...and they have already said they will start the TDAPA process as soon as possible.....and be the new serum pho binder available to Medicare dialysis patients .

Been spending more time on APP lately so visit me on that board if U like and I can explain whats going on there

Kiwi
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rosemountbomber rosemountbomber 4 months ago
Thanks.  Not seemingly doing much for the sp 
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Whalatane Whalatane 4 months ago
From X Approval in China

Frank
@justfactstruth
ยท
1h
$ARDX -CHINESE APPROVAL !!!!!
-On February 25, the official website of the National Medical Products Administration (NMPA) showed that Fosun Pharma's innovative drug Tenapanor (tenapanor hydrochloride tablets) has been approved for the control of hyperphosphatemia in adult
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Followed by some accounts you follow

BioPharm_the_Magnificent
@crypto_biotech
$ARDX

### Milestones
- **Upfront Payment**: Ardelyx received an initial payment of $12 million upon entering the agreement in December 2017.

- **Developmental and Commercialization Milestones**: Ardelyx is eligible to receive up to $110 million in additional milestone payments tied to development and commercialization achievements. A notable example includes a $2 million milestone payment triggered by the acceptance of the New Drug A.

Further milestones would likely be linked to regulatory approval ( DONE ✅ ) and subsequent commercial successes, though specific amounts for each milestone beyond the $2 million are not publicly detailed in fixed increments.

### Royalties
- **Tiered Royalty Payments**: Ardelyx is entitled to receive royalties on net sales of tenapanor in China, ranging from the mid-teens to 20 percent. The exact royalty rate within this range depends on sales performance, with higher sales potentially yielding rates closer to 20%.

### Context of China Approval
Fosun Pharma NOW HAS exclusive rights to market and sell tenapanor in China, Hong Kong, and Macau for this indication, as well as other indications approved in the U.S. Successful approval and commercialization would unlock additional milestone payments and begin the royalty stream based on sales.

In summary, Ardelyx has already secured $14 million ($12 million upfront + $2 million NDA acceptance), with up to $96 million more possible in milestones (from the $110 million total) , plus tiered royalties from mid-teens to 20% on net sales following approval and market launch by Fosun Pharma.

Kiwi
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Whalatane Whalatane 4 months ago
Unicycive Therapeutics (UNCY) has published preclinical data in the ASN journal Kidney360 demonstrating synergistic benefits of combining oxylanthanum carbonate (OLC) with tenapanor for phosphate management.

The study showed that the combination therapy achieved a 41.3% reduction in urinary phosphate excretion compared to vehicle, significantly outperforming both individual treatments.

Key results showed tenapanor alone achieved a 12.5% reduction, while OLC monotherapy demonstrated a 17.7% reduction in phosphate excretion. The combination proved statistically significant (p=0.009 for 0.75% OLC + tenapanor).

This research is particularly relevant as approximately 75% of dialysis patients fail to meet serum phosphate targets set by KDIGO guidelines.
The study suggests OLC's low pill burden and palatable formulation, combined with tenapanor, could improve patient adherence and clinical outcomes in hyperphosphatemia treatment.

Kiwi
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Whalatane Whalatane 4 months ago
Post the highlights of the CC if U have time . Any details on a EU partnership / launch .
As U may have noticed in an earlier post I wrote ...I suspect some Medicare dialysis patients are trying to get scripts for IBS-C to use IBSRELA if XPHOZAH is unavailable..
The downside of this is that ARDX sells IBSRELA for far less per gm of Tenapanor compared to XPHOZAH ...So ARDX will be making less profit if CMS continues to play hard ball and cover XPHOZAH for Medicare , only if it's in the TDAPA dialysis bundle .

So I think CMS and Kennedy's FDA are going to have real issues paying what ARDX wants for XPHOZAH compared to what they pay for IBSRELA ...it's the same drug just different doses.
I also think the real world issues with diarrhea may be worse than reported in the clinical trials .

On a positive note Chairman of the board had been buying stock open market ...at least late 2024

Kiwi
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rosemountbomber rosemountbomber 4 months ago
Fairly decent earnings this morning but stock taking it on the chin in premarket.  Waiting for call to see if they say anything about current qtr or anything going forward. 
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Whalatane Whalatane 4 months ago
Yep. If you are a dialysis patient will poorly controlled serum pho ...just get your Nephrologist to prescribe you IBSRELA instead of Xphozah ...it's the same drug just packaged in different doses .
Covered I believe by Medicare at significantly lower cost ...just one 50 mg IBSRELA pill a day cut in half ....half with breakfast , half with dinner .
Kiwi
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Cosa Cosa 4 months ago
I think you're right which is why Ibsrela had a great Q4. Off label prescription
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Whalatane Whalatane 4 months ago
Well I suspect some dialysis patients are doing a work around using IBSRELA and a pill cutter


What is the daily dose of Tenapanor in Ibsrela vs Xphozah
Answer
The daily dose of tenapanor differs between Ibsrela and Xphozah:
For Ibsrela:
The recommended dosage is 50 mg twice daily, for a total daily dose of 100 mg14. This is typically taken immediately before breakfast and dinner7.
For Xphozah:
The recommended dosage is 30 mg twice daily, for a total daily dose of 60 mg25. This is also taken before the morning and evening meals5.
The difference in dosing is due to the distinct indications for each medication:
Ibsrela is used to treat irritable bowel syndrome with constipation (IBS-C) in adults1.
Xphozah is used to reduce serum phosphorus in adults with chronic kidney disease on dialysis5.
It's important to note that these medications should be taken as prescribed by a healthcare provider, and dosages may be adjusted based on individual patient needs and responses to treatment.

What is the cost of daily dose of each

The daily cost of Ibsrela and Xphozah differs based on their recommended dosages and pricing:
For Ibsrela:
The recommended dosage is 50 mg twice daily, totaling 100 mg per day5. A 60-tablet supply (30-day supply) costs around $1,9671. This translates to a daily cost of approximately $65.57.
For Xphozah:
The recommended dosage is 30 mg twice daily, totaling 60 mg per day6. A 60-tablet supply (30-day supply) costs around $3,3162. This results in a daily cost of approximately $110.53.
It's important to note that these prices are for cash-paying customers and may vary depending on factors such as insurance coverage, pharmacy location, and available discounts or coupons37. Patients with commercial insurance may be eligible for savings programs, potentially reducing their out-of-pocket costs4.


You can get 50 mg of Tenapanor ( IBSRELA ) for $33 per day , if you can get a script written for IBS-C
60 mg dose of Tenaapanor ( XPHOZAH ) will cost dialysis patients $110 per day.

So if you're a dialysis patient that hates the available pho binders ...get your Nephrologist to write you a script for IBSRELA ...for IBS-C ( which is a lot less expensive then a script for XPHOZAH ...and I think CMS / Medicare covers IBSRELA )

Be interesting if we see a big uptick in IBSRELA scripts this quarter .

Kiwi
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Cosa Cosa 4 months ago
No, no deal with CMS. They need to keep doing what they are doing.

OLC is probably going to run into the same politics as Xphozah. The FDA is going to find some BS delaying it for a year or two.
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Whalatane Whalatane 4 months ago
Cosa Xphozah is way over priced per gm compared to Ibsrela ...it's the same drug Tenapanour . They can always try and negotiate a deal ....access to market in exchange for lower price ...just as Amgen did with Repatha .
ARDX's mgt will be under pressure to make a deal before UNCY's OLC is approved ( mid year ) .
UNCY will apply for TDAPA so OLC will be the new pho lowering drug on the market around late 2025 ....UNLESS. ARDX makes a deal with CMS first .
JMO
By the way ...a new trial has been launched using Xphozah for those with Parkinson's experiencing constipation .

Kiwi
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