Ardelyx Inc (ARDX)

Breaking Barriers: How 2026's Top Clinical Leaders Are Disrupting Chronic Disease MarketsJanuary 26, 2026 3:16 PM
PR Newswire (US)

Issued on behalf of Avant Technologies Inc.Equity Insider News CommentaryVANCOUVER, BC, Jan. 26, 2026 /PRNewswire/ -- The medical world is shifting as the global market for next-gen treatments heads toward $88.85 billion by 2030[1], driven by a surge in funding for high-tech cures for long-term illness. A major FDA move at the beginning of the year[2] is now making it much easier to build these advanced platforms, clearing a path for companies that can treat diseases internally without the harsh side effects of traditional drugs. This regulatory shift positions Avant Technologies, Inc. (OTCQB: AVAI), MannKind (NASAQ: MNKD), Vertex Pharmaceuticals (NASDAQ: VRTX), Fate Therapeutics (NASDAQ: FATE), and Ardelyx (NADSAQ: ARDX) at the center of a massive transformation in chronic healthcare.  Smart investors are preparing for a major 2026 rebound as capital flows into the most innovative and results-driven medical platforms[3]. With the total biotech sector projected to reach $9.06 trillion by 2035[4], the biggest opportunities are in companies solving massive issues like diabetes and kidney disease with better clinical execution. In 2026, the market is favoring 'ready-to-go' platforms over early-stage speculation, rewarding the companies that have built the infrastructure to dominate the next generation of medicine.Avant Technologies, Inc. (OTCQB: AVAI) is tackling some of healthcare's biggest challenges with a novel approach: genetically modified cells that produce therapeutic proteins inside the body, protected by a proprietary shield that keeps the immune system from attacking them. The company operates through two joint ventures targeting markets worth hundreds of billions of dollars.The core innovation is a cell encapsulation technology that solves a fundamental problem in regenerative medicine. When doctors transplant therapeutic cells into patients, the immune system typically destroys them within days or weeks. The traditional solution requires lifelong immunosuppressive drugs that cause serious side effects including infection risk, organ damage, and elevated cancer risk. Avant's technology eliminates this problem by creating a protective barrier around the cells while still allowing nutrients, oxygen, and therapeutic proteins to pass through freely.The first venture, Insulinova, Inc., partners with SGAustria Pte. Ltd. to develop treatments for type 1 diabetes and insulin-dependent type 2 diabetes. The approach uses genetically modified cells that produce, regulate and store insulin, essentially creating a bio artificial pancreas that restores natural glucose control without immunosuppressive drugs. The diabetes market opportunity is substantial: 589 million people globally live with type 1 and insulin-dependent type 2 diabetes, projected to reach 853 million by 2050 according to the International Diabetes Federation."Cell encapsulation is a game changer in the field of regenerative medicine," said Chris Winter, CEO of Avant Technologies. "By partnering with SGAustria, we're ensuring that genetically modified insulin-producing cells can thrive in the body long-term and offer the potential of restoring natural glucose control and dramatically improving patients' quality of life. This technology not only minimizes risks like immune rejection but also prevents potential complications such as cell escape or tumor formation, making it a cornerstone for safe and scalable diabetes therapies."Avant's second venture, Klothonova, partners with Singapore-based Austrianova to develop therapies for both age-related diseases and anti-aging therapies using cells that produce the Klotho protein. Research from the Mayo Clinic links declining Klotho levels to arterial stiffness, endothelial dysfunction, and vascular calcification.Both platforms are backed by over 50 peer-reviewed publications representing decades of development. The addressable markets span multiple areas: Alzheimer's disease ($32.8 billion by 2033), cardiovascular disease (32% of global deaths), and kidney disease (850 million affected worldwide).The strategic advantage lies in platform versatility. The same encapsulation technology that protects insulin-producing cells can theoretically protect cells producing other therapeutic proteins, potentially opening pathways into additional disease indications. This positions Avant at the intersection of multiple high-value healthcare markets with a single core technology that addresses the immune rejection challenge across different applications.CONTINUED... Read this and more news for Avant Technologies at:
https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/ MannKind (NASDAQ: MNKD) provided business updates outlining anticipated growth drivers for 2026, including progress across commercial programs and clinical development initiatives following a record-setting fourth quarter surpassing $100 million in net revenue. The company expects two high-potential launches on the horizon with FDA decisions anticipated for Afrezza label updates and FUROSCIX ReadyFlow Autoinjector."MannKind closed 2025 on a high note, marked by milestones that reinforce our growth trajectory—including the acquisition of scPharmaceuticals and a record-setting fourth quarter surpassing $100 million in net revenue," said Michael Castagna, PharmD, CEO of MannKind Corporation. "With two high-potential launches on the horizon, 2026 is shaping up to be a catalyst-rich year that positions MannKind for long-term value creation."Major catalysts include an FDA decision on Afrezza dose conversion with PDUFA date of January 23, 2026, and review of the supplemental BLA for Afrezza in pediatric patients with PDUFA date of May 29, 2026. MannKind also continues advancing its pipeline including nintedanib DPI with first patient enrollment in the INFLO-1 Phase 1b study completed in December.Vertex Pharmaceuticals (NASDAQ: VRTX) provided pipeline and business updates ahead of the J.P. Morgan Healthcare Conference, highlighting strong commercial execution and rapid R&D progress setting up continued growth and important milestones for 2026. The company increased estimates for people with CF in all target markets to approximately 112,000 including approximately 97,000 in core markets, while CASGEVY realized greater than $100 million revenue in 2025 reflecting more than 60 patient infusions."2025 was a year of strong commercial execution and rapid R&D progress, setting up the company for continued growth and many important milestones in 2026," said Reshma Kewalramani, M.D., CEO and President of Vertex. "Building on this momentum, we are focused on expanding our commercial reach in multiple disease areas; advancing the emerging renal franchise, including the potential near-term launch of povetacicept; and progressing our mid- and late-stage clinical pipeline."Vertex expects to complete the rolling BLA filing for U.S. accelerated approval of povetacicept in IgAN in the first half of 2026 using a priority review voucher to expedite review from ten months to six months. The company also plans to complete enrollment in both Phase 3 studies of suzetrigine in diabetic peripheral neuropathy by end of 2026, with more than 500,000 JOURNAVX prescriptions written and filled in 2025.Fate Therapeutics (NASDAQ: FATE) presented updated Phase 1 clinical data of FT819 off-the-shelf CAR T-cell product candidate demonstrating meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus patients now treated and first systemic sclerosis patient dosed. The company continues to advance preparations for a pivotal study and is engaged in discussions with the FDA under its RMAT designation regarding plans to initiate registrational trial in 2026."We are very pleased with the accelerating patient enrollment, the expansion of U.S. clinical sites, and the addition of international clinical sites, which together are enabling broader access to FT819 for patients suffering with lupus," said Bob Valamehr, Ph.D., M.B.A., President and CEO of Fate Therapeutics. "The updated FT819 clinical data continue to demonstrate meaningful and durable responses with the use of less-intensive conditioning chemotherapy and a differentiated safety profile."Preliminary data in Regimen A showed mean SLEDAI-2K score decreased progressively from baseline with DL1 dropping 50% at month 3 and 70% at month 6, while DL2 decreased 65% at month 3 and 78% at month 6. Clinical SLEDAI-2K of 0 was achieved in 5 out of 10 patients with no Grade >2 CRS, ICANS, or GVHD reported.Ardelyx (NASDAQ: ARDX) presented real-world evidence studies of XPHOZAH (tenapanor) demonstrating patient satisfaction and reduction in serum phosphate at the American Society of Nephrology's Kidney Week. The first real-world study showed patients prescribed tenapanor experienced a reduction in serum phosphate of nearly 1 mg/dL on average, with 45.3% experiencing at least 1 mg/dL reduction."We are excited to present new data on XPHOZAH at ASN's Kidney Week, including the first results from our prospective, observational cohort study designed to evaluate the impact of an XPHOZAH-based regimen in a real-world setting," said Edward Conner, Chief Medical Officer. "Our results show the impact XPHOZAH can have in reducing serum phosphorus levels for these patients."Real-world survey data collected through the ArdelyxAssist patient services program showed that 63% of patients reported their phosphate levels were better since starting tenapanor. Among patients who reported a change in serum phosphate levels, 69% indicated their outlook on serum phosphate control was better, with improvements attributed to better control, improved bowel movements, and lower pill burden.Source: https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors- need-to-know/ CONTACT:
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Original: Breaking Barriers: How 2026's Top Clinical Leaders Are Disrupting Chronic Disease Markets

There are market rumors suggesting that Ardelyx (NASDAQ: ARDX) may be acquired by Zydus Life.

Huge gain today!! 😀

I got lucky on those! it ran up hard like a month after I got them. Exited most on that run, hanging on to some. I thought that gap down at $4.40 was going to fill, so I put in new orders for more calls. Didn't even come close to filling.

Guess those calls are doing good today!

Sup guys. I haven't posted for a while. Tutes in control at around 85% now and they are quick to lend their shares out to keep price suppressed. It's a waiting game till the next run. Still holding and bought 2027 $4 calls. I'm hoping we have a good 2026.

They have Ardelyx Assist to try and help those who dont have commercial insurance .....but dont think they make any $ off it .
Ibsrela is going great and getting $25m rev from only 10% of the dialysis population ...Xphozah ..is impressive .
So Mott buying all those times worked out .
Gr8 hedge for UNCY .
If ARDX is ever able to get CMS to change their stance on the new binders in the dialysis bundle ...ie extend reimbursement beyond the first 2 yrs in TDAPA ....would be a huge win for ARDX and eventually UNCY .
Their case vs CMS is under appeal ...hearing later this yr
Kiwi

Haven't had a chance to do a deep dive but wasn't ARDX offering some kind of a deal to patients and covering most of the cost of the drug?

Sorry ..yes I saw the report on VRTX ...no position
I'm stunned ARDX sold $25m of Xphozah with no / little access to Medicare ..in Q2 ...90% of the dialysis population is on Medicare .
It makes me want to go very long on UNCY when I see for certain , the road to approval ...as they will have 100% reimbursement on Medicare for at least the first 2 yrs
ARDX's number for Ibsrela were great

Kiwi

I meant to add that I was a bit distracted from ARDX tonight as I had my disaster du jour (the unstated perils of diversification) with CRSP.  Their earnings beat expectations although they are not at a stage yet to make any money but no danger of dilution. Most of it I think relatex to a poor report from major partner VRTX.  I thought the road here was clear as an insider bought a ginormous amount of stock a few weeks ago.  Oh well. 

I kept some thinking it wouldn't be a bad idea as a hedge with UNCY - but I guess I should have kept all my shares.  Hindsight I guess 

Did you keep ARDX ...great qty results especially for Ibserla

Kiwi

$ARDX -
(Bloomberg) -- Ardelyx shares are up as much as 11%, the most intraday since May. Jefferies analyst Dennis Ding says an update on the firm's ongoing lawsuit with the US government, could be a reason for the stock's move.
-Last year, Ardelyx sued the US Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) over how the company's drug for kidney-dialysis patients, Xphozah, might be reimbursed.
-A federal judge ruled against the drugmaker in November
-Ding says there was an update on the firm's appeal, "which we've been flagging as a significant call option not in buyside expectations"
-Says a new court docket update set Sep. 25 as the date for oral arguments
-A positive appeals decision by year-end "could restore Part D for Xphozah and add back a large growth driver for the stock"
-"Expectations for Xphozah are zero right now, which makes this a very interesting call option"
-Maintains buy rating on ARDX, PT $8

ARDX has 11 buys, 1 hold, 0 sells; avg PT $10.73: data compiled by Bloomberg

Kiwi

Mott's picked up another 400k shares in the last 10 days.

Thinking about dropping my $2 bid down to a buck - always thought the insiders feed themselves excessive amounts of shares.

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?

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

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

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!

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

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

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

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 Parkinson’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

Nice move this morning.  If there is anything behind it, we peons will be last to know

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

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.

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

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 :--)

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

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

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.

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

Thx ..yes IBSRELA is fine ...the problem is XPHOZAH and the lack of Medicare coverage ....and no progress YTD in resolving that .
Kiwi

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."

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

You were lucky! It's under $4 now...

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

That was a terrible Q1!! negative quarter over quarter. Not good...

That's when I'll be buying more lol.

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

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

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

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 it’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 what’s best.

As much as you are correct in your assessment, depending on politicians is not a great business strategy.

100%
It’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.

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

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.  

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.

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

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

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