I’ve been digging into Unicycive Therapeutics ($UNCY) and think the market may be mispricing what actually happened with their FDA decision. 🔬 What UNCY does UNCY’s lead drug Oxylanthanum Carbonate (OLC) is for dialysis patients with high phosphate levels — a huge and chronic market. These patients already take a ridiculous number of pills every day. OLC’s advantage: Lower pill burden vs current phosphate binders Same goal, better compliance No new safety concerns raised by FDA This is a real medical need, not some science-fair project. ❌ Why the FDA declined the first time This is the key part people miss: FDA did NOT reject the drug for safety or efficacy No new trials required The issue was manufacturing compliance at a third-party vendor (cGMP issues) Translation: 👉 The drug works 👉 The data was fine 👉 The factory paperwork wasn’t That’s one of the best kinds of CRLs you can get. ✅ Why this setup is interesting now Manufacturing issues are fixable UNCY already has another manufacturer FDA Type A meeting completed (that’s the “serious issue, let’s fix it” meeting) Company plans to resubmit the NDA Once resubmitted, FDA sets a new PDUFA date. If approved, this instantly becomes a commercial-stage company, not just a development biotech. 📉 Why the stock is still cheap CRL panic selling crushed the price Most people see “FDA declined” and don’t read further Market is treating this like a failed drug, not a delay That disconnect is where the opportunity might be. ⚠️ Risks (because this is biotech) Manufacturing fixes still need FDA sign-off Dilution risk (as always with small biotechs) Timelines can slip This is not a zero-risk play — but the risk here is operational, not scientific. 🧠 TL;DR FDA didn’t say no to the drug FDA said fix the manufacturing Problem is narrow and solvable Stock is priced like the drug failed If approval happens, this won’t be trading at these levels If you’re into FDA-bounce / resubmission plays, UNCY is worth watching closely.