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Update on the UNCY trial ( note earlier post on ARDX / UNCY )
https://classic.clinicaltrials.gov/ct2/show/NCT06218290
Not sure of the completion of trial date March 31st 2024 and I think they have increased the number in the trial from 60 to 90 patients .
Update on the UNCY trial ( note earlier post on ARDX / UNCY )
https://classic.clinicaltrials.gov/ct2/show/NCT06218290
Not sure of the completion of trial date March 31st 2024 and I think they have increased the number in the trial from 60 to 90 patients .
Well the market will be getting nervous if they don't announce their trial is fully enrolled fairly soon
They have always said trial read out in Q2 / 24
Trial is 6 wks ( I mistakenly said 12 wks in my prior post ) and they will need 4-6 wks to collect , double chk all the data etc before presenting the results .
So say a total of 12 wks starting March 1st ...takes us into June ( last mth of Q2 )
Kiwi
I sold my position in ARDX in the $4's...and was surprised by the guidance for IBSRELA......so definitely sold to early .
Kiwi
I sold my position in ARDX in the $4's....and have held a position in UNCY for some time.
ARDX's XPHOZAH (2 small pills a day ) is an obvious competitor to UNCY OLC ( 3 small pills a day )
The main reason I no longer own ARDX ( and I was surprised by the positive guidance on ISBRELLA ....basically the same drug just priced lower per gm ) is because of the pricing for XPHOZAH
ARDX has priced X at around $3,100 a month . Kaiser has X at Tier 5 which means a copay of around $1,000 a month to the patient
So without ARDX buying down the copay ...I doubt many of these dialysis patients ( who are often low / moderate income ) can afford it .
To date none of the 3 dialysis clinics my wife rounds are using XPHOZAH ...primarily because of the prior approval paper work and being unaffordable to her patients .
The Nephrologists are interested in X particularly for those considered intolerant to binders ...but PA's and cost are major hurdles.
UNCY has yet to announce their pivotal trial is fully enrolled ...that IMHO will be a major catalyst .
They need to carefully / slowly increase dosing of OLC to reduce serum phosphorous below 5 before the end of the 12 wk trial ......going slow will reduce side effects / AE's .
Assuming their pivotal trial succeeds I expect mgt / bod to sell the Co to a large Pharma already in the CKD space . If they go it alone they will raise capital ...and then on approval need to price OLC at a price patients and payers can afford.
JMO
No position in ARDX and currently long UNCY
Kiwi
Thoughts on ARDX and UNCY...informed opposing opinions welcomed
I sold my position in ARDX in the $4's....and have held a position in UNCY for some time.
ARDX's XPHOZAH (2 small pills a day ) is an obvious competitor to UNCY OLC ( 3 small pills a day )
The main reason I no longer own ARDX ( and I was surprised by the positive guidance on ISBRELLA ....basically the same drug just priced lower per gm ) is because of the pricing for XPHOZAH
ARDX has priced X at around $3,100 a month . Kaiser has X at Tier 5 which means a copay of around $1,000 a month to the patient
So without ARDX buying down the copay ...I doubt many of these dialysis patients ( who are often low / moderate income ) can afford it .
To date none of the 3 dialysis clinics my wife rounds are using XPHOZAH ...primarily because of the prior approval paper work and being unaffordable to her patients .
The Nephrologists are interested in X particularly for those considered intolerant to binders ...but PA's and cost are major hurdles.
UNCY has yet to announce their pivotal trial is fully enrolled ...that IMHO will be a major catalyst .
They need to carefully / slowly increase dosing of OLC to reduce serum phosphorous below 5 before the end of the 12 wk trial ......going slow will reduce side effects / AE's .
Assuming their pivotal trial succeeds I expect mgt / bod to sell the Co to a large Pharma already in the CKD space . If they go it alone they will raise capital ...and then on approval need to price OLC at a price patients and payers can afford.
JMO
No position in ARDX and currently long UNCY
Kiwi
I sold my position in ARDX in the $4's....and have held a position in UNCY for some time.
ARDX's XPHOZAH (2 small pills a day ) is an obvious competitor to UNCY OLC ( 3 small pills a day )
The main reason I no longer own ARDX ( and I was surprised by the positive guidance on ISBRELLA ....basically the same drug just priced lower per gm ) is because of the pricing for XPHOZAH
ARDX has priced X at around $3,100 a month . Kaiser has X at Tier 5 which means a copay of around $1,000 a month to the patient
So without ARDX buying down the copay ...I doubt many of these dialysis patients ( who are often low / moderate income ) can afford it .
To date none of the 3 dialysis clinics my wife rounds are using XPHOZAH ...primarily because of the prior approval paper work and being unaffordable to her patients .
The Nephrologists are interested in X particularly for those considered intolerant to binders ...but PA's and cost are major hurdles.
UNCY has yet to announce their pivotal trial is fully enrolled ...that IMHO will be a major catalyst .
They need to carefully / slowly increase dosing of OLC to reduce serum phosphorous below 5 before the end of the 12 wk trial ......going slow will reduce side effects / AE's .
Assuming their pivotal trial succeeds I expect mgt / bod to sell the Co to a large Pharma already in the CKD space . If they go it alone they will raise capital ...and then on approval need to price OLC at a price patients and payers can afford.
JMO
No position in ARDX and currently long UNCY
Kiwi
DAR53. thx for the info .
I know you are trying to help but IMHO don't push Vascepa to hard in this situation .
His Cardiologist has prescribed him a blood thiner so is unlikely to prescribe Vascepa as well .
Since he was also prescribed a beta blocker ( something my wife prescribes for her CKD/CAD patients ) they may also be concerned about Afib ...another reason they may not prescribe Vascepa .
Re Beta Blockers
https://www.bhf.org.uk/informationsupport/heart-matters-magazine/medical/drug-cabinet/beta-blockers#:~:text=In%20people%20who%20have%20had,should%20usually%20continue%20for%20life.
Good luck
Kiwi
Well of course ...who needs email when we have the post office ? Who needs google search when we can go to a library ?
The only constant ...is change .
AI will help us accelerate research ..including on the uses for Vascepa .
JMO
Kiwi
If U are looking for a catalyst ...look for data that supports Vascepa use in Long Covid
https://www.science.org/doi/10.1126/science.adl0867
Something for U Seve
Seve. AI is not a bubble. I've used and still use ChatGPT in discussions about Vascepa , heart disease , eye disease and kidney disease .
We are at the beginning ...ala 1995 with the internet ....not 1999
As regards biotech in general. There are several drugs approaching critical clinical readouts . I've mentioned them before, VERA on this board and UNCY, RZLT on those boards ...or on Dews board .
AMRN is reliant on script growth and management controlling cost and right now script growth is a slow grind higher .
Script numbers from Spain may be the next near term catalyst .
Kiwi
DAR53 I'm not an MD but have had an angiogram / angioplasty with identified coronary plaques ...not bad enough that I needed stents ..but did require max medical therapy . I'm in my 70's and these posts are just my opinions .
To clarify an earlier post referring to calcified coronaries. I'm referring to soft plaque that has become calcified. Calcified coronary plaque makes it difficult to deploy stents properly . Shockwave therapy ( SWAV ) has the technology to deal with this problem.
Many patients are hesitant to have stents deployed . A common practice in Japan is to use the SWAV therapy ..IVL ...to crack the calcified plaque and use a drug eluting balloon to expand the artery to increase the blood flow ....and stop there ...no stents .
So you might want to ask if the interventionist Cardiologist identified the form of coronary plaques .
Vascepa is unlikely to have any effect on calcified plaques but may provide benefit in over all coronary health via its effect on the endothelial cells lining the coronary arteries.
JMO
Good luck
Kiwi
DAR53 ...forgot to mention risk of Afib ...if the patient has any history of Afib they may advise against adding Vascepa
Good luck
Kiwi
CMO buying
http://archive.fast-edgar.com/20240221/AP22V222E22252T2222D2CO2PM7AU222B262/
His and the CFO's were open market purchases
Kiwi
DAR53. I'm not a medical personnel but my wife is. I have had an angiogram which identified blockages in coronary arteries ( inherited condition ...He FH ) and am on max medical therapy ...Repatha , max dose Statins and Vascepa .
I'm sorry to read the extent of the coronary blockages you identified. Once coronaries are 90% blocked the patient usually has stents inserted ...or if blocked by a buildup of calcium ..IVL treatment ( SWAV ..stock symbol ) . You may want to find out what kind of blockage ....soft plaques or harden calcified plaques.
There is no down side to adding Vascepa UNLESS the patient has a history of bleeding .
What is the patients LDL cholesterol number ?
It needs to be under 50 mg/dl .
Given the age ...84 yrs old ...difficult situation .
Best of luck
Kiwi
Thx ...the more DD the better ...including informed opposing opinions
Re price targets ...I'm the last person to ask that .
I owned SLNO in the $ 2's . Thought it might triple on good P 3 results . In fact it ran up to $20 ,,,,at which time I sold .
It's now trading at $48 a share !!!!!
You might look at UNCY also . My wife rounds dialysis clinics. None of her patients are at serum phosphorous goals as they hate the current meds
Near term catalyst will be Co announcing pivotal trial is fully enrolled.
VERA is another Co I'm invested in. They appear to have a functional cure for IgAN ( kidney disease ).
All the above are very speculative and are vulnerable to sell off's on any increase in interest rates ...let alone bad data readouts .
Let me know if U look at UNCY
Kiwi
Well congrats if you are in EYPT . There are some differences between DME and wAMD ...from ChatGPT
Thx Dew ...appreciate the DD
Kiwi
RZLT follow up ...CFO buying
http://archive.fast-edgar.com/20240220/AP27R222E222H2S2222A2CO2NABDZ222B262/
Kiwi
RZLT. ...my pitch ...informed opposing opinions welcomed
RZ402 is the near term catalyst . P2 data on DME ...with 3 doses 50mg, 200 mg and 400mg .
The 50mg and and 200 mg dose were shown similar to placebo in safety profile. Believe this is the first time using 400 mg dose .
Trial is fully enrolled with 94 patients
12 wk trial followed by 4 wk follow up
Data mid / late Q2 2024.
High risk spec , some talented people in / advising the Co
Kiwi
RZ402 is the near term catalyst . P2 data on DME ...with 3 doses 50mg, 200 mg and 400mg .
The 50mg and and 200 mg dose were shown similar to placebo in safety profile. Believe this is the first time using 400 mg dose .
Trial is fully enrolled with 94 patients
12 wk trial followed by 4 wk follow up
Data mid / late Q2 2024.
High risk spec , some talented people in the Co
Kiwi
Dew. some background
https://www.sec.gov/Archives/edgar/data/1509261/000110465921060677/tm2115088d1_ex99-1.htm
Kiwi
Dew. Thx for looking at this ...always appreciate your opinions
They are hoping this may have benefit in the early stages of DME thru the drugs broad spectrum of anti inflammatory and anti leakage MOA's
https://ir.rezolutebio.com/news-events/press-releases/detail/313/rezolute-kol-event-highlights-significant-unmet-medical
RMB re RZLT The P2 results due in Q2 is for DME ( diabetic muscular edema ) currently treated with eye injections . So this indication is not ultra rare and haven't looked into the trial enough to gauge any chance of success . Thats RZ402
RZ358 is for the ultra rare disease for hyperinsulinism ...P 3 data mid 2025
Hyperinsulinism can result in the removal of the pancreas and life expectancy drops fairly fast afterwards .....
Just starting my DD on this so above views may need correction / clarification
Poster North might have some insight re hperinsulinism .
Others here know more about DME and may offer an opinion on chance of P2 success.
Kiwi
Canes Glad ARDX worked for you . I of course sold the news ( FDA approval of Xphazoh )...and its doubled since then :--(
I think it's doubled on IBRESLA sales but we'll see in the earnings report.
Will be interesting to see how fast sales for Vascepa increased in Spain ...in the next ER
Are U still in VKTX ?
Kiwi
RZLT
Hi North ... IOVA ...shoot me now :--) I sold my position on approval .."sell the news " which has turned out to be a mistake lately ( altho it wasn't on R-IT approval Dec 2019 ) . Saw it trading up 25% plus after hrs. . Markets closed on Monday isn't it ...so I'll wait til Tuesday to shoot myself.
Suggest you chk out UNCY and RZLT ....Vivo Capital and Nantahala are in both in size ...and so is Stonepine Capital who were invested in AMRN back in the day .
Be well
Kiwi
PS I remembered you are a T1 diabetic ...so I'd be interested in your opinion on RZLT ...addressing forms of hyperinsulinism
UNCY is targeted to most of the dialysis patients my wife prescribes to
Vivo Capital and Nantahala Capital each have significant positions in SLNO, UNCY and RZLT
There are some common features to the diseases both SLNO and RZLT treat ...Insulin production appears to be a key factor .
SLNO was a huge home runs for these funds ...hopefully UNCY and RZLT can do similar
Kiwi
Nantahala Capital ...the previous post was from Fintel data . Not sure how accurate it is . It may be reporting increases in shares throughout 2023 .
Anyone with more accurate data , please post
Kiwi
UPDATE. There is Nantahala Capital mgt and Nantahala Capital partners .. Increase is in Capital partners .
I think trying to keep each under 10% to reduce filing / disclose requirements
Nantahala Capital Management, LLC
UPDATE
2024-02-14 13G/A UNCY / Unicycive Therapeutics, Inc. 1,207,416 ( previous number of shares ) 3,475,713 ( new number of shares ) ...almost tripled their position
Kiwi
RMB The potential is over $1B in the US market ...$2B worldwide
I should emphasize POTENTIAL
First they have to show side effects close to Fosrenol ( its bioequivalnt ) in a dialysis population ....pivotal data due Q2 ...next catalyst is the Co announcing the trial is fully enrolled
Then they have to price it so patient copays are reasonable.......something ARDX failed to do with Xphazoh
Note about the trial . Goal is to get serum phosphorous below 5 .
I think they will go slow ( increase dose slowly ) to minimize side effects .
My wife currently prescribes some Fosrenol , and thinks OLC could be a game changer as its one small pill with meals that can be swallowed not chewed .
Patients hate having to chew phosphate binders following a meal. ....so adherence is poor .
Re pricing . Most dialysis patients are on limited income ...they are in a dialysis chair 3 days a week ... 4 hrs at a time ...so 2 of those days are work week days .
So most rely on generics ...Sevelamer for instance ...but hate them as large pills etc etc .
So if approved pricing must be affordable.
Vivo Capital own about 10% of the Co . They are huge in SLNO that I told U about , and also significant position in RZLT ( think I'll start a position )
VKTX ...I have a position in that . Current take over spec , data due soon .
Good luck
Not investment advice etc etc
Kiwi
North. re HSCS. are you aware of their competition ...first mover advantage etc
https://anumana.ai
No position in HSCS or several of the others you mentioned.
Good luck
Kiwi
Hey we're human. I owned IOVA and sold on FDA approval ...now up 30% plus after hrs :--(
Hope U are well
Kiwi
Capt ..gr8 DD
Kiwi
Actually walked by that hotel back in the day
Kiwi
" When life looks like easy street ...theres danger at the door "...thx for that link
Kiwi
Well what did U expect ...once I had sold it :---)
Thx for your DD
Kiwi