Unicycive Therapeutics Inc (UNCY)

I kinda laugh (or else I would have to cry) that it seems to me that when UNCY resubmitted the NDA, the very first thing the FDA needed to do was schedule an inspection. Not wait until the six months were up, not wait for label discussions.  

How low will they let the atm take this?
Just asking because the next warrant tranche ain't gonna happen for quite some time now, 2 to 6 months and Gupta gotta eat and buy more promos for himself.

It’s crazy if this 40 percent drop is solely because FDA didn’t find time to do it

But it seems so based on couple reports posted

I just added some.

The actual cash burn last qt was around $6m . They will have raised a similar amount thru the last 2 weeks before Friday ...thru their ATM .
Next catalyst is confirmation that this will be a Class 1 turnaround since the FDA inspection has apparently already been scheduled .
JMO
Kiwi

If they did hit it, it’s good news

They probably just need another 10mm to 15mm for buffer. They probably have that by now

I thought you were right with your call early this morning but nevertheless I went back to see what happened when CRMD got their 2nd CRL and could see reaction was muted and it bounced back quickly.  Didn’t want to sell anything in my retirement account (probably should have) to get cash to buy UNCY.  Then I guess the idea of buying continued to grow within me, I turned to my taxable and just bought more there. 

I use logic - fairy dust makes me sneeze

how u know there is ATM selling?

Nope ...you have your on site guys in India ( Shilpa etc ) give you daily updates . Has the FDA shown up today ? This is likely to be a surprise inspection .
Each day closer to the 29 th they haven't shown up is each day you sell some shares in your ATM to raise cash .
Cos U know you'll need that cash in case what happened ...actually happens .

Market is figuring out that this may be a fairly quick turnaround ...and Co has raised enough cash to see them thru .
JMO
Congrats on your buy earlier today
Kiwi

Massive volume so I'm guessing it's atm selling shares because don't know anyone willing to sell down here.

Yeah for sure.  Wouldn’t you have called the mfr to see if the FDA had been there?

Now, When did they know it? Seems mighty odd that we had massive atm selling both Friday and again today -

As a betting man I would say they knew much earlier than this morning but they wanted to move atm shares.

I hope the lawyers on the plaintiff's side can investigate the timing of the current fiasco and roll it into the pending case.

Totally agree Canes that this is on the FDA. Pure bullshite. Now to be honest, if it was me in the room conducting label discussions with someone from the FDA, I would have at some point reached across the table and said: "Have you Mfers completed the inspection of the facility?".. I know that for sure now - a third time,
I would definitely be asking the FDA if they had completed it if I am ever talking to them about anything.

Kiwi I appreciate your acknowledgment about my concerns regarding the FDA. I recall the entire staff that handled travel coordination for the inspectors was terminated and had to be rehired. They quickly realized they were invaluable. I’d like to remind everyone that European inspectors found no deficiencies at this plant a few days after our inspector raised concerns. Perhaps there were no legitimate issues. There’s no excuse for the FDA not getting the inspection done, period. They probably forgot. As far as UNCY knowing if the inspection had or hadn’t been performed what would you expect them to do? I’d imagine they’re inspecting fairly regularly. So, our management assumed it’d been accomplished. Besides it’s not UNCY’s purview to coach the FDA. The right thing for the FDA to do is complete the damn inspection in the next 60 days then give us our approval.

Thx. from Reuters
Piper Sandler's Yasmeen Rahimi called the CRL a "minor setback" and continues to see a high likelihood of OLC's approval, citing the absence of new FDA concerns about the drug's efficacy or safety.

Kiwi

Reiterate Buy @22/share. Per management, the FDA has communicated the inspection assignment to the vendor in writing, and management expects it to occur within weeks, given the agency's typical unnaounced scheduling for these visits. Once completed, the path to resubmission and a final decision is expected to be short, consistent with Class 1 type turnaround rather than a new cycle.

Thx for that Piper Sandler piece
Re the FDA ...my DD

The FDA has not publicly disclosed the specific, granular details of the facility deficiencies, which is standard practice for ongoing regulatory reviews.

However, because the FDA did not re-inspect the site before issuing this second rejection, the "persistent issues" are technically procedural and administrative open items rather than newly discovered manufacturing failures.
The regulatory loop explaining how this happened includes:

Official Status Remains Unresolved:
Under FDA rules, once a manufacturing site is flagged with deficiencies (often documented during an earlier inspection), its official compliance status is marked as non-compliant.
Until the FDA physically goes back to conduct a Pre-Approval Inspection (PAI) to verify corrections, those original deficiencies are legally classified as "unresolved" or "persistent".

The PDUFA Deadline Trigger:
The FDA is bound by strict Prescription Drug User Fee Act (PDUFA) action dates.
Because the regulatory clock ran out before the FDA could physically send investigators to re-verify the contract manufacturer in India, the agency was legally required to issue a rejection based on the last recorded official status of the plant.

Kiwi

So now sure if you guys have read the Piper/Sandler press release. While we were disappointed to see UNC Y receive a second CRL related to deficiencies previously identified at a third party manufacturing vendor management provided thoughtful commentary which instills us with confidence specifically during review dialogue the agency told unsi that the third party inspection could occur up to the last few weeks of the June 29th deadline unfortunately during the last hour the FDA informed UNCY that the inspection had not occurred and the only way for the agency to push the date was through a CRL. Notably management highlighted the inspection has now been assigned where they are prepared to resubmit OLC once the inspection is complete and the third party vendor is deemed to compliance UNCY can resubmit OC under type 1 NDA so the new PD UFA date should occur much quicker in three to four months october 2026 d Piper/Sandlers response.

"

How would the FDA know if its concerns about the 3rd party contractor had been corrected..... without inspecting the facility ?
Following the 2025 CRL the FDA terminated any further discussions with the Co over labeling ...not the case this time according to the Ceo

Unicycive said it resubmitted the application after concluding that the third-party manufacturing vendor had made sufficient progress in addressing the previously identified regulatory deficiencies.
The company had reviewed those remediation efforts with the FDA during a Type A meeting held in September 2025.

The company also noted that it remains engaged with the FDA on labelling and packaging matters, with its most recent communication from the agency arriving on June 29 regarding carton and container labels.


But yes ...worst case scenario it starts the 6 mth clock all over again ...which is what the market has priced in

Kiwi

And all his croonies - Time to bring in real professionals

Agreed- the best thing that could happen to this company would be to replace Gupta!!

Why would the fda need to go there again if it’s just a labeling issue….maybe last December uncy submitted a new label that they thought addressed the crl of June of 25….apparently the FDA didn’t like it thus another crl…Gupta and management fault they need to go …fired or resign over this latest failure

This management really doesn't give a crap about shareholders they have proven that time and time again.

No conference call?  That’s lame.  Help investors with at least some explanation as why the inspection didn’t happen.  Companies almost always do a conference call…

From Ai- Why the Delay Happens In many cases, an FDA inspection delay occurs because: The facility is located internationally and requires overseas travel logistics.There are unforeseen scheduling conflicts or resource constraints with FDA investigators.A third-party contract manufacturer (CMO) has outstanding compliance issues preventing the FDA from clearing them.How to Resolve ItTo push the application forward, the sponsor's next steps generally include:Requesting a Meeting: The sponsor can request a Type A meeting with the FDA to discuss the inspection logistics and get a timeline.Submitting an Amendment: Once the inspection is completed and any resulting Form 483 observations are addressed, the sponsor resubmits the application (which restarts a shorter PDUFA review clock, typically 2 to 6 months). So 2-6 months regardless??

good call so far. hard for me to add as I feel like I have no clue what's going on, after 1 year, the same issue and FDA didn't even bother to visit. and management seems no clue?

You have to remember one timportnt thing at this stage: Uncy still has that pending lawsuit and they will be very careful about making any press release that could affect that ourcome.following this new CRL.

Why $10 or $12 when they can buy up the atm at $4 and be a hostile takeover.

Maybe if all the pharma companies used US manufacturers many of these overseas issues could be eliminated and the higher mfg costs would be justified.
The company I worked for years ago providing packaging materials were right here in FL and had FDA licenses for many many drug components. One was Vitarich in Naples and Enzemedica in Venice or Fort Myers. Vitarich was a huge compounding lab as I remember, I don't recall who took them over.

US manufacturing means company officials could jump on a plane and be on-site within hours if need be. Here it seems Gupta was busy promoting himself while neglecting what he was being paid to do TAKE CARE OF THE BUSINESS THAT WAS PAYING HIM...... VERY VERY WELL I MIGHT ADD. Failure should get him a door and a kick in the azz out of it.

The way I read this is that the contents of the NDA did not sufficiently address the FDA concerns about the 3rd party's to warrant a re-inspection.
This explains both the failure of the FDA to inspect the facility and the need for a completely new NDA.
This restarts the 6 month clock all over again. Just my take.

This would also be the time for a competent company that has management that knows how to launch a new product and is interested in olc to buy Uncy for 10-12$ while the stock is being hammered…..they can have my shares

Time to tell this India supplier to hit the road and go elsewhere

Because the 2-month timeline is too short to schedule, execute, and process an official pre-approval inspection (PAI),

Well, with regards to UNCY and its Indian manufacturer, it turns out 6 months is too short to schedule, execute and process an official pre-approval inspection!

Is there a Class 3 submission?

Totally unacceptable Gupta needs to go….wonder how many institutions well stick around for another year….maybe this is why the Vivo Capital dude resigned from the board months ago

Facility still has to be inspected ...it could fail that inspection .
If FDA insists on a Class 2 re submission ( 6 mths ) ...stock could tank.

The third avenue is an extension of the current NDA to give FDA more time to complete their re inspection .
Need to do some DD on that
Kiwi
If the FDA reaches the PDUFA deadline and a required inspection has not been completed (or if a facility is deemed unready), the agency will typically issue a Complete Response Letter (CRL).
A CRL acts as a rejection of the current cycle.
The sponsor must then resolve the inspection hurdles and resubmit the application, which triggers an entirely new review cycle (usually lasting 2 to 6 months).

Unicycive shares plunge after FDA issues Complete Response Letter for kidney disease drug (UNCY)June 30, 2026 8:42 AM
IH Market News Manufacturing issues delay regulatory approval Unicycive Therapeutics Inc. (NASDAQ:UNCY) shares fell 37% on Tuesday after the company disclosed that it had received a Complete Response Letter from the U.S. Food and Drug Administration for its resubmitted New Drug Application covering oxylanthanum carbonate. The FDA said the application remains affected by deficiencies at a third-party manufacturing facility that were first identified in a Complete Response Letter issued in June 2025. The agency did not inspect the manufacturing site during its review of the resubmitted application. Importantly, the FDA raised no concerns regarding the drug’s clinical safety or efficacy and did not request any additional clinical data from the company. Company continues discussions with the FDA Oxylanthanum carbonate is being developed as a treatment for hyperphosphatemia in patients with chronic kidney disease who are receiving dialysis. Unicycive said it resubmitted the application after concluding that the third-party manufacturing vendor had made sufficient progress in addressing the previously identified regulatory deficiencies. The company had reviewed those remediation efforts with the FDA during a Type A meeting held in September 2025. The company also noted that it remains engaged with the FDA on labelling and packaging matters, with its most recent communication from the agency arriving on June 29 regarding carton and container labels. Clinical package remains unchanged The New Drug Application is supported by data from three clinical studies, including a Phase 1 trial in healthy volunteers, a bioequivalence study and a tolerability study involving chronic kidney disease patients undergoing dialysis. The submission also includes preclinical findings together with chemistry, manufacturing and controls data. Unicycive Therapeutics stock priceThe post Unicycive shares plunge after FDA issues Complete Response Letter for kidney disease drug (UNCY) appeared first on US Editors. Original: Unicycive shares plunge after FDA issues Complete Response Letter for kidney disease drug (UNCY)

Uh Oh ...on more DD
The FDA will not inspect the facility during a Class 1 resubmission review.

By regulatory definition under the Prescription Drug User Fee Act (PDUFA), a Class 1 resubmission is strictly reserved for minor issues—such as final labeling, safety updates, or minor chemistry, manufacturing, and controls (CMC) clarifications—and triggers a brief 2-month review clock.

Because the 2-month timeline is too short to schedule, execute, and process an official pre-approval inspection (PAI), any resubmission requiring a facility inspection is automatically disqualified from Class 1 and must be categorized as a Class 2 resubmission, which carries a 6-month review clock.

Kiwi

So let me see if I understand correctly. The last time it was a Class 2 because the facility had failed an inspection. This time it would be a Class 1 because the inspection was only delayed. But doesn't it still go back to the failed inspection?

As far as tanking if a Class 2, if you look at the last one announced Jan 29, the stock dropped some but in a day was back above, so who knows.

Well Canes had posted on his impressions of the difficulties the FDA is now facing ...loss of staff etc .
I had posted on problems for drug manufacturers in India due to fuel rationing etc ...so I'm sure those FDA inspectors over there have had their hands full.

Again ...this is not a failed inspection ...its a delayed inspection
JMO
Kiwi
Next catalyst ...IF UNCY says they have a Class 1 re submission . If its a Class 2 , stock will tank again

Ok fine. But assuming a class 1 resubmission will it still take UNCY 3 months to resubmit and if the FDA could not schedule an inspection in 6 months will they be able to do it in 2 months?

What I don't understand, is if the FDA has had on their TO DO list for the last 6 months to do an inspection which they haven't done yet, why don't they tend to that rather than putting the inspection on another schedule only after another NDA is submitted?

I do think the stock will be higher some time in the future so broke my rules and picked up more in my taxable account. Can't do it in retirement as no loose change and without an earned income can't send money in.

Remember this day IF they get a class 1 re submission ....and then PASS that re inspection .
Thats the bet
Not investment advice
Everyone should know their risk tolerance
JMO'
Kiwi

Another thing. Don't these analysts talk to company management? This is what a Wainwright analyst put out recently:

H.C. Wainwright said it remains bullish on the upcoming PDUFA and recommends taking advantage of any stock weakness prior to approval.

The FDA takes either 2 or 6 months to review and respond to a resubmitted New Drug Application (NDA).
The timeline is set by the Prescription Drug User Fee Act (PDUFA) and depends on the complexity of the changes made:

Class 1 Resubmission (2 Months): Reserved for minor changes or easily addressed deficiencies, such as minor formatting updates, safety updates, or minor chemistry/manufacturing revisions.

-------------
We are hoping for a Class 1 re submission . This is a scheduling issue ( so far )

Kiwi

I think it would help me and buoy my spirits if you tell me that my understanding is wrong. Here is what I seem to think:

3 months for company to resubmit another NDA
They are given a new PDUFA date 6 months out from application. So are we not looking at 9 months?

Taking longer than 3 mths ?...yes thats the risk. . And they could also fail the re inspection when it takes place .
However ...assuming CEO isn't lying and the labeling discussion are still on going and another Type A meeting to discuss manufacturing issues etc is NOT being considered ...its down to scheduling .
Primarily the FDA's schedule to actual complete an inspection .
Remember form 483 ...if they are issued ..are usually issued on date of inspection . So we should know very quickly if they failed ...when that inspection takes place

Kiwi

Not to argue, and not knowing all the ramifications, but UNCY says they will have to resubmit an NDA:

“We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA.”

So to me it is not as simple as having the inspection and then FDA saying you have approval. Sounds a little lengthier to me.

Like why the Hell do they have to resubmit an NDA. Can't the FDA hold on to the current on and sign off on it after the inspection?

Unicycive understands that the FDA has not yet conducted its inspection of that third-party manufacturing vendor as part of the review process of the resubmitted NDA.

This is IMHO a delay .....NOT a failed re inspection.

Yes there is a cost but its manageable IF they can get the re inspection completed and passed with in the next 3 mths
JMO
Kiwi

Kiwi I follow your logic and came to the same conclusion that buying here under $4 might make sense. Only thing you would lose would be time waiting for the stock to recover. But from a money management position for me I would be going into it too heavy but definitely will not be selling at this price. Good luck to us all.

You don't have to tell me about CRMD as I have been in that stock for a long time.

I understand and have no problem about being tougher on overseas manufacturers, but they accepted the NDA gave a PDUFA date of June 29 that would include re-inspection of the facility. Tougher - fine. But you must inspect to be tougher.

The fda has gotten a lot tougher when it comes to overseas
manufacturers, including those in India... This stance has been
known for some time now. Note, I have been aware of this issue
for some years now because of issues CRMD had with a manufacturer
in Spain.. that cost them 4 years of delays and me a hell of a lot of LOST
profits... (primarily dilution killing off the target price)


https://bla-regulatory.com/fda-surprise-inspections-foreign-facilities-2025/#:~:text=On%20May%206%2C%202025%2C%20the%20U.S.%20Food%20and,and%20other%20regulated%20products%20for%20the%20American%20market.

Why This Policy Matters Now for Overseas Facilities
Increased Scrutiny for Exporters — The FDA is prioritizing sites supplying high-volume or high-risk products to the U.S. market.
Pilot Program Lessons — India (2022) and China (2023) pilots uncovered more data integrity and quality violations when inspections were unannounced.