Unicycive Therapeutics Inc (UNCY)

$UNCY institutional investirs are loading slowly 💪💪🏋️‍♂️

$UNCY Seems like sell the news event and probably some heavyweight didnt wanna be tied up for another 5 month till FDA decision. Now people are coming back to their senses.

$UNCY Unicycive Therapeutics UNCY PDUFA Date Summary 02Feb2026 https://youtu.be/qzRT0dmpssk Well that turned out to be a good buy for the 2nd time, in the summary we will look at everything going on, but I feel like we are fairly derisked with this stock!

$MIST To my Milestone longs, a question. Has anyone been following or have an active piece of $UNCY? Is this a similar situation? Trying to get so DD on that symbol.

$UNCY onyl inspection is needed. In other words, it is over as long as the factory inspection schedule is set. There are no other documents to review. Move like $SVRA

$UNCY Does the receipt of the class 2 crl make UNCY a more attractive company for buyout or partnership opportunity? And if bought what kind of share price could we expect?

$UNCY is most hated stock, no management credibility, failure after failure, I am holding until June pump to $8

$UNCY I wager that this was another small pump and dump for the ATM liquidity That swine Gupta… Expect more of the same.

$UNCY totally unjustified sell-off

$UNCY there you have it Total garbage

$UNCY That beautiful 3 month chart just got busted.

$UNCY added more.‘just need to be patience. Still have about 5 months to wait for any real news.

Noble Capital Markets Research Report: Unicycive Therapeutics ($UNCY) – OLC Resubmission Accepted For FDA Review Unicycive Announced FDA Acceptance Of The NDA. Unicycive announced FDA acceptance of its resubmission of the New Drug Application (NDA) for OLC (oxylanthanum citrate). The resubmitted application has been classified as a Class II complete response, with a six-month review period. Read full report here: https://www.channelchek.com/news-channel/unicycive-therapeutics-uncy-olc-resubmission-accepted-for-fda-review

$UNCY @RunningRobert1 How much lower can it go? Time to start a position or wait for it to go down more?

$UNCY FDA really volatile recently with biotech companies…hopefully they don’t raise any new issues (REPL is a good example of FDA giving guidance and then pulling rug). This seems like a slam dunk to me but time will tell!

$UNCY added 1000 more… now it’s a very huge position.

$UNCY I was hoping for class 1

$UNCY 3,045 watching 1/29/2026

Unicycive Therapeutics (Nasdaq: $UNCY) announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The FDA deemed the resubmission a Class II complete response, resulting in a six-month review period, and assigned a PDUFA target action date of June 29, 2026. Unicycive Therapeutics is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/unicycive. “We are pleased that the agency has promptly accepted the resubmission of our NDA for OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “We are advancing our commercial preparation activities in anticipation of a potential launch of OLC later this year, to help provide an important treatment option to patients with chronic kidney disease (CKD) on dialysis who continue to struggle with hyperphosphatemia.” The NDA is supported by data from three clinical studies, multiple preclinical studies, and chemistry, manufacturing and controls (CMC) data. The FDA did not raise any concerns regarding OLC’s preclinical, clinical, or safety data included in the original NDA submission. The company ended 2025 with an unaudited cash position of $41.3 million, providing runway into 2027. See today’s press release at https://ir.unicycive.com/news/detail/118/update---unicycive-therapeutics-announces-fda-acceptance-of Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. The company’s lead investigational treatment, oxylanthanum carbonate, is a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Its second program, UNI-494, is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation by the FDA for the prevention of delayed graft function in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. Led by CEO Dr. Shalabh Gupta and a seasoned executive team including CFO John Townsend, EVP Doug Jermasek, EVP Pramod Gupta, Dr. Atul Khare, and Dr. Guru Reddy, Unicycive is committed to addressing unmet needs in kidney disease treatment. Learn more at Unicycive (https://unicycive.com/) and B2i Digital (https://b2idigital.com/). Disclosure: David Shapiro, CEO of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. This post is not intended to solicit the sale of UNCY or any security, and it is not intended to offer any opinion on UNCY as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the complete Disclosure in the Risks and Disclosures section of https://b2idigital.com/disclaimer.

$UNCY sell The news Classic

$UNCY Great news. Fda acceptance of NDA resubmission. Added a few more. Target date 5 months from now.

$UNCY Vanguard JUST bought 700k more shares