UNCY Unicycive Therapeutics Inc

$UNCY Well finally they have a second third party manufacturing facility. The Sec. email didn't mention who or where the third party manufacturing facility is. But it did say it has already passed the FDA inspections previously. Also they just hired a new person who has several FDA drugs in various companys join Uncy in Oct. Things might be looking a lot better.

$UNCY before the last CRL, share price was around 9. Approaching the will be assigned new PDUFA, 9 will be the minimum expected since the manufacturing issues will be finally gone.

$UNCY After back-to-back CRL disasters, I strongly suspect this could be the bottom.I believe the risk of a 3rd CRL has decreased now that the company has finally decided to work with a third-party manufacturing vendor currently being inspected by the FDA.FDA's filing acceptance of the resubmitted NDA could trigger an upward price movement (waiting for FDA's NDA filing acceptance before entering seems more reasonable). However, it shouldn't be forgotten that despite all these positive developments, the company still carries binary risk. For this reason, I will try not to over-allocate my position size. Good luck to all

$UNCY pure speculation: surprise inspection news will come this month for the original manufacturer, UNCY files amendment and gets a class 1 review. Approval by Xmas. Everyone selling makes sense. Can’t have money tied up in this until January/February when it starts to pump before approval. However, they’ll miss the jump when they announce the inspection and class 1 review soon!

$UNCY Unicycive Therapeutics announced today the appointment of Meredith Manning to its Board of Directors. Manning brings over 25 years of biopharmaceutical industry experience to this clinical-stage biotechnology company, which focuses on developing therapies for patients with kidney disease. She will serve on the Audit, Compensation, and Nominating and Corporate Governance Committees, and will chair the Nominating and Corporate Governance Committee.

🔥 $UNCY TOTAL GAME CHANGER RE-SUBMISSION TODAY! 🔥 The market panicked in June for NO reason! Today’s NDA text proves the 2026 CRL was a pure FDA travel/scheduling lag, ZERO clinical safety or efficacy issues. THE MASTERSTROKE: Unicycive just added a VENDOR B for OLC with top-tier FDA "No Action Indicated" (NAI) cGMP status + 12-month stability data already DONE. Approval is now mathematically de-risked. Standard PDUFA timeline is 6 months, BUT the original vendor (Granules/Shilpa) visit is officially ASSIGNED. If FDA completes it soon, UNCY triggers a shorter approval track! Supply redundancy secured. Cash runway into 2H 2027. Shorts are completely trapped. LFG!! 🚀🚀

$UNCY a. Selection is based on extensive research of the inspection history, only the one with the cleanest and recent inspection will be selected. b. They need to re-do PPQ, which should not take long (days can be done) c. They need stability to determine the shelf-life of the products manufactured from the new facility, which takes time. However, they can leverage early stability data once a comparability between the old vs new facility can be established. Overall, a good strategy but investors need to wait for a little bit longer, but is much better than sticking to the same facility. Much much better

$UNCY The strongest development is that on August 12, Unicycive said its third-party OLC manufacturer had received written FDA notification that the facility inspection had been assigned. That is materially further along than simply waiting for FDA to decide whether to inspect. Unicycive also said it intends to promptly resubmit the OLC NDA after a successful inspection.

$UNCY will add more along the way to approval to accumulate more shares. Previous CRLs are purely due to facility inspection issues. Now these issues are gone for the new facility. Approval> 90%

$UNCY Some good news, PDUFA will be much quicker as its just factory that needs inspection, fed will not make them wait long.

My DD on $UNCY OLC manufacturing: The 2020 contract with Shilpa Medicare for Oxylanthum Carbonate points to a key third-party partner: Granules India's high-volume Gagillapur facility. Shilpa provides the complex nanoparticle API, while Granules handles massive tablet compression (MOQ >5M). The FDA CRL was strictly a scheduling issue for a pending reinspection, NOT new manufacturing failures. In fact, Danish health authorities (EMA standard) recently audited the plant with zero major issues. The facility is fully validated under strict European standards. Once FDA completes the assigned site visit, approval is on a fast 2-month track. Bullish. 🚀

$UNCY A few early findings from the FDA CRL dataset I’ve been building: Since 2022, I’ve identified 726 unique NDA/BLA applications and 213 searchable CRL events. Of applications receiving an observed CRL: • 69.4% involved CMC/product quality or facility issues • 52.2% involved facility/cGMP/inspection issues • 16.1% received a second observed CRL • Of those receiving a second CRL, just 13.8% (4 of 29) went on to receive a third, only 2.2% of all CRL applications in the cohort • Median time from first CRL to approval was 12.1 months That context matters for $UNCY. The CRL was tied to a third-party manufacturing vendor/inspection issue, not clinical efficacy, safety, or the drug substance. That type of problem is far from unusual in the FDA data. Prelim figures, still burning though data tokens compiling the data. What is a clear signal so far is U.S. ownership and manufacturing correlates to a measurable reduction in the risk of a CRL compared with foreign issuers and manufacturing. More to come.

$UNCY here is the big picture ; FDA has raised no efficacy or safety concern and requested no additional clinical data. UNCY’s regulatory update⁠ * Gupta said no product, labeling or packaging issues remain. * Shilpa—the primary manufacturer—was reportedly inspected and found compliant. * The problem is confined to Shilpa’s fill-finish/drug-product subcontractor. * The original vendor continues supplying commercial products to the United States, according to Gupta. * Management expects a Class 1 resubmission based on regulatory guidance. * The backup vendor is already inspected and compliant, has produced OLC, and the stability data and submission package are reportedly ready. * Piper Sandler also characterized the second CRL as a minor setback and continued to see a high likelihood of eventual approval.

$UNCY latest update says cash runway is into 2027. Wonder if they need cash soon as it’s cutting it close with still no clarity on inspection and the eventual BLA submission.

$UNCY really not much additional information during the webcast, but I felt this time he was very forthcoming and seems very optimistic. I was pleasantly surprised when he mentioned they expect a class one resubmission.

$UNCY fda is saying it will be a surprise inspection, and Gupta has no idea when it will happen. He is saying type 1 resubmission.

$UNCY with all the time passed since the first CRL, UNCY would have been better off with another partner than Shilpa/CMO and cld re-file with another party? Exclusivity seems to hinder progress...

$UNCY Inspection has been completed and discussion with FDA about the NDA resubmission is underway.

$UNCY is anyone still buying shares or all yhe 5 people in here burned out from this 2 year nightmare

$UNCY maybe some one got some insider information, btw which is totally legal in the united states