UNCY Unicycive Therapeutics Inc

$UNCY On Oct 28, $UNCY Director Meredith Manning was granted 27k call options at a $3.76 strike. Why this matters: she was just CCO at Soleno Therapeutics—another single-drug 505(b)(2) company—and steered them to a $2.9B ($53/share) buyout by Neurocrine. She knows the exact playbook for this specific type of pipeline. $3.76 is her new baseline. So we are safe till 3.76

$UNCY (Unicycive), a kidney-disease biotech: FDA accepted its OLC phosphate-binder resubmission as a Class II, six-month review, PDUFA March 25, 2027, now using a new drug-product maker after two CRLs tied to the original plant. Worth ~$105.8M at $3.8 (16:00 ET Oct 20, 2026); $61.4M cash and investments at June 30, 2026, runway guided into 2H 2027. Risk: the company doesn't know if FDA will pre-inspect the new vendor, whose site got No Action Indicated in March 2024. If the original plant passes an inspection, it plans to seek a shorter timeline.

$UNCY USFDA audit started today of granules India which may be the site due to which CRL was received Do your own due diligence...however this is huge...

$UNCY this is a tricky one. Ole UNCY is caught in a mighty biopharma sell off. It's not just UNCY, it's just about every small cap biopharma. The market is spooked right now and risky assets are not in style. Sadly, until the drug is approved, this stock is a risk a lot of investors are pulling away from. This stock is different from a typical pdufa play at this point though. While it is possible we all have to wait for a pdufa date for approval. It's possible too that the FDA conducts the assigned inspection this week without problems. I have concerns about the drop and the pattern we are seeing, but at that same time, if you pull your money out right now, you may miss the one announcement we are all waiting on that could happen any day-inspection complete. With the short interest so high right now, an announcement like that could create a squeeze, maybe. Here's to hoping! I'm staying in, I'll either sink or float with this one

$UNCY For Q3, the update I’d watch for is whether the FDA has told Unicycive that the new site needs an OLC-specific inspection. Reports are around November 12 for earnings

$UNCY Stay away from shorters...no fundamentals changed for the companies....have a patience and faith in your instincts

$UNCY Bought more, I only believe my own research. No safety and efficacy issues, only facility inspection. Sooner or later, they will get it approved, and 2x my investment. 6 months, wonderful. 1-2 years, 2x, not bad.

$UNCY Granules inspection should be completed this week. Let’s hope to get positive news in November

$UNCY Must be debbie downers who are selling here 😆…this either does 2x/3x in 5 months or 1 month. If any manufactuing gets cleared approval chances are 90% or more.

$UNCY A Real circus act due to the FDA incompetence of not inspecting this Third party manufacturer in time of Review and subsequently issuing another CRL due to their incompetence. Then finally inspecting this facility and issuing 11 Inadequacy’s. Company already selected another Manufacturer and received a Review date for March. Again they are Relying on the Incompetent FDA to either approve the use of this facility which was inspected in 2024 or issue another CRL because they want to Reinspect this facility and don’t have the time before March. Drop to 3.25 in after hours reflects issues at old facility which probably won’t be worked out by March when New facility drama comes into focus. FDA SUCKS This is why small Bio suffers unnecessarily.

$UNCY Granules India earnings call 11/2/26 “The US FDA conducted a cGMP inspection of the facility from October 19 to October 30. This was the first FDA inspection since the Warning Letter issued in February 2025, following the 2024 inspection. The inspection concluded with a Form FDA 483 containing 11 observations. Based on our assessment, none of the observations relate to data integrity, cross-contamination, or facility upkeep. They concern investigations, change control, process and equipment qualification, visual inspection controls, and documentation practices. There is no impact on manufacturing or distribution of products from this site. We will submit a comprehensive response within the stipulated 15 business days, detailing our corrective and preventive actions. We believe these observations are addressable and remain focused on demonstrating the effectiveness and sustainability of our quality systems”

$UNCY The top holder with 4.8M is RA Capital Management & Vivo Capital: These are venture and growth funds. They typically back small cap biotech companies through pivotal Phase 3 trials and NDA filings with the primary thesis of catalyzing an acquisition by a mid to large cap pharmaceutical firm upon FDA approval. I believe Gupta will sell immediately after fda approval. He is also ex Wall Street ! Let’s make some quick money in few months !

$UNCY two good days and talk about a vibe shift on here 😂 I'm here for it though! Finally!

$UNCY So I looked into this. Seems like a large market can indeed be captured here. Like I said will keep buying under 3.5 we should be going north very fast if any of the manufacturing clears.

$UNCY The next 30 will bring wealth or despair. My hope is wealth for my friends still invested in this! The projected price target range in this time frame is between $1–$6 based on IV of 211.18%. Closing stock price: $3.77 Annualized IV: 211.18% Time: 30 days Expected move formula: Expected move = $3.77 × 211.18% × √(30/365) = ±$2.28 Projected range: Low: $3.77 − $2.28 = $1.49 High: $3.77 + $2.28 = $6.05 Implied 30-day range: $1.49–$6.05. 📊

$UNCY adding here soon. Couple weeks away from the FDA acceptance and the new PDUFA date PR.

$UNCY if granules is facility, they reported in earnings call today that they believe observations will be resolved in 90-100 days. Kind of what I thought. I don't believe the inspection was sufficient to move up the uncy NDA timeline, but it will be a good fallback if something weird happens with the current facility on the pending NDA.

$UNCY this will drop even further once UNCY makes the announcement that their orginial manufactur failed inspection again. So now your money will be tied up for another 4-5 months until this starts running before approval at the end of March. SO frustrating.

$UNCY Broker conf presentation early next week, would be great to get some details whats going on instead of speculation and selling on every Indian generic stumble...

$UNCY Congrats! This is what we were waiting for. PDUFA ~5 months out. This can get very interesting. Cheers!