Unicycive Therapeutics Inc (UNCY) Share Price

Well theres last minute legal action from ARDX
From X Per court order, CMS has until noon on the 29th to respond to injunction request and $ARDX has until noon on the 30th to file a reply. Order signed by judges Katsas and Garcia. Katsas is a Trump appointment. Gacrcia is a Biden appointment.

So there may be a chance for a compromise re new Oral pho drugs and the dialysis bundle .....ie full coverage in TDAPA for 2 yrs and a 5 yr ( instead of 3 ) slide down to competing with generics .
Pure speculation on my part
ARDX might agree to lower the price for Xphozah since its over priced compared to Ibrsela per gm ( its the same drug )

Any deal ARDX makes , helps UNCY
JMO
Kiwi

What is driving UNCY and ARDX higher today?

new 13Gs filed

https://ir.unicycive.com/sec-filings/all-sec-filings

Xphozah is an adjunct therapy. Phosphate binders, ineffective though they may be, are Frontline therapies. Ardelyx was always going to be hurt the most by the KPA not passing in my opinion

Thanks Chevelle, that was good and supportive to the stock, but I am still surprised how well UNCY has held up with the realization that the KPA is probably not passing. Seems to have hurt ARDX much more.

https://ir.unicycive.com/news/detail/91/unicycive-therapeutics-announces-publication-of

RMB. IIRC There are no FDA approved drugs for Delayed Graft function ( a serious risk in kidney transplants )
UNCY completed a successful trial in healthy volunteers . Next step is for agreement with the FDA on the design of a P 2 trial for those undergoing a kidney transplant . Co doesnt have the cash right now to run such a trial so the options are ...sell UNI 494 to a BP or wait till OLC is approved for serum pho lowering and raise cash then ....to promote OLC and run a P2 UNI 494 trial .

Kiwi

Thanks.  Sounds like we are hanging on to this baby. 

Re change in valuation over the last 3 mths . Don't forget UNI-494 . My wife treats a lot of kidney transplant patients and between 30-50% of them experience Acute Kidney injury which can lead to loss of the new kidney ...devastating for the patient


About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease.

UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.
UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.
UNI-494 has completed a Phase 1 dose-ranging safety study in healthy volunteers.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease, end stage renal disease.


Kiwi

RMB. Well apparently theres a last minute push to get the Kidney Patient Act attached to some end of year funding bill . Next wk is the last wk of 2024 to act apparently. .
Passage would probably be a big boost to ARDX and UNCY as passage this yr seems a long shot and I think largely priced in .

Re market constantly mis pricing .
A lot a positive developments over the past 3 mths ...chk the history ...plus another hedge fund buying in
Successful UNI-494 trial in Acute Kidney injury
Presentations at Kidney wk including a video interview
Acceptance of NDA
etc

Kiwi

Was thinking the talk of passage of KPA and how it could boost stock prices here and ARDX. If passage of the bill would boost the stock prices, then the corollary is that there must not be much priced in? So, my question is if the KPA does not get enacted before the end of the year, can we assume that these current prices will not crater that much? How can UNCY's valuation be 3 times what it was a couple of months ago. The market constantly mis-prices stocks.

In Hellio Nephrology yesterday

Phosphate binder rule is disease-specific discrimination

Add topic to email alerts
In April, CMS issued guidance for the inclusion of oral-only drugs in the end-stage renal disease bundled payment. The directive included Xphozah as a renal dialysis service.

Xphozah, (tenapanor, Ardelyx) is a first-in-class phosphate absorption inhibitor approved to lower serum phosphorus levels for adults on dialysis. CMS intends to include the agent in the ESRD prospective payment system effective Jan. 1, 2025, but unlike calcimimetics and phosphate binders, tenapanor will have its own transitional drug add-on payment adjustment (TDAPA) and be excluded in the calculation for a permanent add-on payment. Under this guidance, tenapanor will be moved from Medicare Part D to Part B, and Part D pharmacies will no longer be allowed to fill prescriptions to Medicare ESRD beneficiaries.

Premila Bhat, MD, FASN, AHSCP-CHS, and J. Ganesh Bhat, MD, FASN
Tenapanor in phosphate control
Hyperphosphatemia and metabolic bone disease are the most challenging clinical issues facing nephrologists who treat patients on dialysis. Phosphates are ubiquitous in the diet, and normal kidneys excrete most of the phosphates absorbed from the gut. With the decline of kidney function, phosphates accumulate in the blood, leading to secondary hyperparathyroidism and metabolic bone disease.

Since dialysis became a routine procedure for patients with ESRD, traditional management of elevated phosphorus has been through oral drugs that bind phosphates and prevent absorption. Aluminum hydroxide gel and calcium-containing compounds, such as calcium acetate or citrate, were the mainstay for controlling hyperphosphatemia in dialysis. Aluminum toxicity and concerns about calcium burden led to the introduction of other phosphate binders, such as sevelamer carbonate, sevelamer hydrochloride, lanthanum carbonate and iron-based phosphate binders.

Premila Bhat, MD, FASN, AHSCP-CHS
Premila Bhat
J. Ganesh Bhat, MD, FASN
J. Ganesh Bhat
Dietary restriction and dialysis using currently available dialyzer membranes alone are insufficient to maintain phosphate balance; hence, there is a need to bind phosphate in the gut to prevent absorption. Compliance with conventional phosphate binder therapy is difficult and directly attributable to the “pill burden” and need to take the medication with or soon after meals multiple times a day. Gastrointestinal adverse events and intolerance to the binders further complicate the matter.

Many patients on dialysis cannot maintain a serum phosphorus level between 3.5 mg/dL and 5.5 mg/dL even when using medications to manage the condition. The addition of tenapanor as an add-on therapy for patients who have an inadequate response to phosphate binders or intolerance to any dose of phosphate binder would make these goals easier to achieve and prevent complications due to secondary hyperparathyroidism.

Legal action
In July, Ardelyx started legal action arguing that CMS did not have the authority to include oral-only drugs, such as phosphate binders and phosphate absorption inhibitors, in the bundled payment system. From a mechanism-of-action point of view, Ardelyx argued, these drugs should not be labeled as renal dialysis services because the drugs are not administered either orally or parenterally during dialysis treatment, and a parenteral form of phosphate binder or absorption inhibitor is unlikely to be developed.

The judge dismissed the case on Nov. 8. CMS will move the drug from Medicare Part D to Part B as planned on Jan. 1, 2025. Ardelyx has yet to accede to CMS’s request for it to apply for a Healthcare Common Procedure Coding System code and TDAPA status, leaving dialysis providers with no clear pathway to be reimbursed.

CMS stated that moving phosphate binders from Medicare Part D to Part B improves beneficiary access to these medications. Medicare Part D enrollment among patients with ESRD had increased to almost 80% in 2021, and twice as many patients with ESRD qualify for low-income subsidies as those without ESRD. Medicare seeks to improve access to these drugs to all patients with ESRD under Part B, and moving phosphate binders to Part B from Part D would have a negligible impact on access to these drugs. However, this change would burden dialysis providers to procure the drugs be the gatekeeper, keeping an eye on the cost.

Equity in ESRD
ESRD is one of the clearest examples of racial and ethnic disparity in health care in the United States. Black and Latino patients are affected by ESRD four times and 1.3 times more, respectively, than white patients. Furthermore, poverty, as measured by dual eligibility status and low-income subsidies, makes ESRD the poster child for disparity in health care in the country. Since the introduction of the ESRD bundle, CMS has experimented with ineffective ideas, such as TDAPA and transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) and mandatory ESRD Treatment Choices model, which have an enormous and often negative impact on the lives of patients with ESRD.

Under the current method used by CMS, innovative drugs and technologies are less attractive to innovators and investors, limiting access of patients with ESRD to the advantage of these drugs and technologies in stark contrast to patients who have cancer or heart disease.

For example, Korsuva (difelikefalin, Cara Therapeutics) is a novel anti-pruritic drug that could have treated severe itching for one of six patients on hemodialysis. After the TDAPA period for the drug ended, CMS adopted a 3-year adjustment that spread the cost of it across all Medicare treatments. To recover the cost of providing the drug to a single patient, a facility would have to treat hundreds of patients who do not require it. No facility has a sufficient patient population to make that equation work. Consequently, only a fraction of patients who would have benefited from the drug are now receiving it, and its future availability remains uncertain.

Under the current bundled payment and drug designation process, CMS has reinforced systematic discrimination against patients with ESRD that the administration has indicated it seeks to end. The current system stifles innovation and puts the financial burden on dialysis providers to bear the full cost of providing these expensive drugs and technologies to patients without adequate reimbursement.

Patients with ESRD are discriminated against with regard to access to novel therapeutics, devices and diagnostics compared with their peers without ESRD. Oncology, cardiology, diabetes and patients with other rare diseases enjoy a rich innovation pipeline due to a reimbursement system that rewards companies for innovating in these therapeutic areas. It is time for Congress and other policymakers to revisit how innovation is sustainably paid for in ESRD to ensure brave patients are not left behind.

For more information:
Premila Bhat, MD, FASN, AHSCP-CHS, is CEO of Tidal Home Dialysis LLC, and a partner at NY Kidney Hypertension Medicine in Ridgewood, New York. She can be reached at pbhat@atlanticdialysis.com.
J. Ganesh Bhat, MD, FASN, is a principal at Atlantic Dialysis Management Services LLC, in College Point, New York. He can be reached at jbhat@atlanticdialysis.com.
Published by:
nephrology news and issues logo
Sources/DisclosuresCollapse
Disclosures: The authors report no relevant financial disclosures.


Kiwi

There was an article yesterday in Helio penned by 2 Nephrologists explaining how the current CMS dialysis bundle system for dialysis patients ....stifles new innovation , punishes Co's that develop new drugs for CKD patients ...especially dialysis patients ...and discriminates because most on dialysis are people of color .
They pt out that the Cardiology community by contrast has far better access to new drugs than the CKD dialysis community .
They say the whole CMS TDAPA program for dialysis patients needs to be changed .

Kiwi

I see that UNCY has come alive today but trying to figure out why.  Any news on Kidney Act?

It's Alive ....:--)
Kiwi

Yep. The market is probably pricing in a high chance of failing to pass the Kidney Patient Act this yr . Eventually I think the ARDX issue will be resolved like Amgens introduction of Repatha
At first they wanted $14,000 a yr ....few scripts were accepted for coverage
2 yrs later they dropped the price to around $6,000 a yr in exchange for wide coverage ...now its widely used ..I'm on it
Kiwi

Kiwi, I understand the reasoning as to why ARDX would have the most immediate benefit if the KA passes.  But I would assume by the same logic that if the KA fails to be passed that UNCY would drop less than ARDX?

3 new co sponsors ( 1 is Republican ) for the Kidney Patient Act . Total of 43 cosponsors now . An informed opinion I'd read on these bills is that you need at least 50 co sponsors to tilt the scales towards passing the Act
Still about a week and a half before they shut down for the yr

ARDX will see the most immediate benefit if this pass's ...but UNCY should benefit also and maybe push the PPS over $1
JMO
Kiwi

Hope so I’ve been accumulating UNCY the last few months …..got a decent position and still adding here and there

Yep ..it applies to Medicare patients on dialysis . ARDX did not apply to the TDAPA process which determines pricing because CMS wants Xphozah in the dialysis bundle which would mean in about 5 yrs Xphozah would have to compete with generic pricing .
Their view is ...why spend the time and $ running trials etc if CMS mandates the new drug to generic pricing in 5 yrs . It's rare for a Co to even breakeven in the first 2 yrs of launch .
On the other side ...ARDX over charges for X relative to Ibserla ( as explained previously ) so CMS is basically saying FU to ARDX
Meanwhile Medicare dialysis patients look to be the loser at least near term as their scripts may not be renewed .

UNCY is also a big winner if a deal is worked out favorable to ARDX.... as it will apply to all new oral pho binders

Kiwi

Xphozah is shown to still be available by ardelyx but the company has not chosen to file a specific payment program under Medicare …that will restrict patients access to the drug…unless of course legislation changes that

I think what might be firming up the price this week are the two conferences. One today and one Thursday. Depending how high the stock price gets to and what action/inaction on Kidney Act in the Senate, I may look to book some profits. Not a bunch but at some maybe.

it's good for me!

I got my average down enough for a healthy profit if it hits $1. I was just being greedy I suppose.

Shame about Xphozah. Sounds like it needs a miracle to thrive in 2025

it's good for me!

I got my average down enough for a healthy profit if it hits $1. I was just being greedy I suppose.

Shame about Xphozah. Sounds like it needs a miracle to thrive in 2025

Is that good or bad for U ? I thought you were hoping for a pull back to 50c... to load up ?
You were right about the pull back after the NDA was accepted ....definitely a good buying op . .
The sh#t is about to hit the fan on Xphozah ( ARDX ) . My wife wrote 2 scripts for it today . Both were rejected on the basis the drug will no longer be available ( as it currently stands ) Jan 1.
The patients on it and the Nephrologists prescribing it ..... are pissed off to say the least .
Kiwi

Is that good or bad for U ? I thought you were hoping for a pull back to 50c... to load up ?
You were right about the pull back after the NDA was accepted ....definitely a good buying op . .
The sh#t is about to hit the fan on Xphozah ( ARDX ) . My wife wrote 2 scripts for it today . Both were rejected on the basis the drug will no longer be available ( as it currently stands ) Jan 1.
The patients on it and the Nephrologists prescribing it ..... are pissed to say the least .
Kiwi

This may get back to a $1 pretty soon.

So on a quiet holiday half day, UNCY will do more than average volume. Definitely looks like this will work out. (Of course after I say that I hope I don't jinx it). Those senators need to move their butts and get it done.

Right back at ya.  Man I must be really declining not spelling there correctly.  

Thx for the info
Happy Turkey day
Kiwi

Not sure about today, but their was news today of fund diving in in the 3rd qtr.

https://www.marketbeat.com/instant-alerts/great-point-partners-llc-buys-shares-of-8559000-unicycive-therapeutics-inc-nasdaquncy-2024-11-27/

Uncy has two conference presentations next week…12-3 and 12-5…..hoping for continuation of share price momentum from these

Re ARDX ..the only news I have is that ARDX filed a request for a stay on the judgement . Judge has agreed to hear that request on Dec 13th IIRC
Congress is out this wk isn't it ?

From the opinion I read on ARDX's challenge to CMS . They lost on a technicality similar to case case you know about ...Marjac / AMRN
Kiwi

I notice even ARDX up pretty strong.  Any news maybe about Senate scheduling a vote?

Up 22% as I type ...on very heavy volume ...whales wading in
JMO
Kiwi

RMB Ah yes the poutine industry :--)
Re market due for profit taking . I think at this time of year the risk for UNCY is more the harvesting of loss's for tax write offs . Profit taking ( and the tax consequences ) seem less of a risk ....JMO
Re nervous about the market ...always a good sign . Whenever one is confident theres no risk ...is when theres the most risk

I added to UNCY this am . Not suggesting anyone do likewise .
I think the video link I posted the other day was very interesting as it showed the interviewer ( Dr Topf ) recognizing the significance of IIRC 91% in the trial getting to serum pho goal ...plus his interest in UNI -494 re Acute Kidney injury / delayed graph function .

I think the FDA has granted them Orphan drug designation for delayed graph function . Delayed graph function is a real risk in kidney transplants where the new kidney is slow to start working or begins to fail .
UNI-494 appears to reduce that risk

But high risk spec . Will feel better if / when they get the PPS over $1 for 10 days and remove the R/S risk
Kiwi

Thanks for posting Kiwi. Rather positive for our little UNCY.
UNCY to be involved in two other conferences next week:
https://charts.stocktwits-cdn.com/production/original_594030670.jpg

On other news, I am beginning to get nervous. Just as things were looking very good for my small bios, with a typically good month or two for small caps coming up, I am now concerned that the overall market, which is due for at least some profit-taking, might take a real dump.

News this afternoon about across the board tariffs on Mexico and Canada starting Jan. 20. This kind of stuff spooks the market, generally. Only positive, would be for the fledgling American poutine industry.

My first thought was whether this would violate the USMCA, which was signed 6 years ago, after tearing up the NAFTA agreement. I can't get away with not paying a parking ticket.

Following Kidney Wk
Medical Research Analyst positive
The clinical trial results for OLC represent significant progress in treating hyperphosphatemia in CKD patients on dialysis. The 90% success rate in achieving phosphate control with OLC, particularly with 69% of patients requiring ≤1500/day, demonstrates strong efficacy. The favorable safety profile and recent NDA submission position OLC well for potential FDA approval.

The combination study of OLC with tenapanor showing synergistic effects (3.3x greater than tenapanor alone) suggests potential for enhanced treatment options. The Phase 1 results for UNI-494 also show promise, with therapeutic levels achieved and good safety profile, setting the stage for Phase 2 trials in kidney injury prevention.


Market Research Analyst positive
This comprehensive data presentation strengthens Unicycive's market position in the nephrology space. With an NDA submitted for OLC and positive Phase 1 results for UNI-494, the company is advancing two potentially valuable assets. The hyperphosphatemia market represents a significant opportunity, as millions of CKD patients on dialysis require phosphate control. The demonstrated efficacy and lower dosing requirements could provide competitive advantages over existing treatments.

The successful development of both products could significantly impact the company's 38.27M market cap, particularly if OLC receives FDA approval. The positive reception at ASN Kidney Week adds credibility to their clinical development program.

Kiwi

I think it may be hard to pull forward scripts of Xphozah since pharmacies may only dispense 1 mth at a time .
This is a problem my wife runs into with her dialysis patients . Many want pharmacies to dispense 3 mth scripts of various drugs so as to get a discount and also for convenience but the pharmacies often refuse and allow only 1 mth fills.
ARDX says if the Kidney Patient Act doesnt pass this yr they will provide Xphozah free to Medicare patients for the first 2 mths in 2025 ....meanwhile theres a major patient advocate movement underway to sort this mess out to enable continued access .

I agree that UNCY is less effected ...but will also be a winner if any deal or delay is worked out re new Oral pho drugs and the dialysis bindle

Kiwi

Not to be contrarian but I actually expect a big pull forward in Q4 for Xphozah. Wouldn't surprise me to see Ardx kill it in that quarter and post monster results.

I have, however, transitioned most of my kidney money to UNCY as I think they'll be less affected by the bundling. I actually wanted a flush under 50 cents to finish averaging down

From the recent kidney conference .
Interviewer starts off poorly prepared but recovers


Kiwi

Yes There will be less of a reaction in the UNCY stock for the reason you mentioned
ARDX is saying they will supply Xphozah free of charge to Medicare patients who lose coverage in Jan ...for the first 2 mths only
Nephrologists are probably already pulling back from starting Medicare patients on Xphozah if they think access to the drug is uncertain in Jan .
So biggest reaction will be in ARDx's stock if the Kidney Patient Act pass's before Jan 1st .......but that may still be a long shot despite the effort they are making now
Kiwi

Do you think, assuming the Kidney Act, that there would be less of a reaction in UNCY's stock price compared to ARDX's since UNCY won't receive approval for another 6 months or so?

UNCY will benefit if the Kidney Patient Act pass's ...new push in Congress

https://higherlogicdownload.s3.amazonaws.com/NRAA/8eb5e347-a0f4-4216-aac1-f22e0d697983/UploadedImages/Content/2024/RHA_Advocates_to_Protect_Access_to_Phosphate-Lowering_Therapies_11_21_24.pdf

Kiwi

Benchmark analyst Bruce Jackson reiterates Unicycive Therapeutics (NASDAQ:UNCY) with a Speculative Buy and maintains $3 price target.
9:38 AM EST, November 22, 2024 (Benzinga Newswire)
Write to Benzinga at editorial@benzinga.com

Well as contrarian sentiment indicators go ...this is me at my most bearish recently
Whalatane
11/14/24 10:24 AM
#543 RE: ErnieBilco #542
So a reverse split seems inevitable ?
I sold most of my position when the stock sold off after the FDA accepted the NDA...PPS acted the opposite to what I expected .
IMHO the only thing that saves this Co is passage of the Kidney Patient Act ...and thats no sure thing
Good luck
Kiwi

Been up since this post ..:--) forcing me to buy back what I sold :--(

Vivo Capital still report owning 9.99% of the outstanding shares

Kiwi

Looks like the market agrees with you . Good PPS action lately
Kiwi

You beat me to the punch Kiwi, as I was making dinner when I read Mr. Mister's post. This was pretty easy to verify. Hoping we can get more representatives on board asap. I have written to mine. Even tried writing to my old one in Florida. Not sure if you saw the other bill I was interested got passed in the House this past week and is awaiting action in the Senate. It had over 200 sponsors. The one eliminating the WEP and GPO for SS.

https://www.congress.gov/bill/118th-congress/house-bill/5074/cosponsors

Now 41 cosponsors /. Apparently 50 co sponsors is the tipping pt ( more likely vs less likely to pass ....not guaranteed )

My guess is the PPS of ARDX and UNCY will track the progress in getting more co sponsors by EOY .
Insider at ARDX just made a large insider purchase

Kiwi

Thanks for the note though I wonder how trustworthy this guy actually is. Several weeks ago, he posted about a large wall street bank predicting $ARDX would win its lawsuit against CMS.

Well, we all know how that turned out.