NEW YORK, June 30, 2026, 09:06 EDT
- Unicycive traded at $4.02 before the bell, sinking 47.76% from its $7.70 finish on Monday. Volume was running over four times the usual level.
- The FDA issued a second complete response letter for oxylanthanum carbonate, this time due to third-party manufacturing issues rather than questions on safety or efficacy.
- At the premarket mark, equity value drops to about $107 million. After accounting for the company’s $57.1 million in cash and marketable securities, that leaves around $50 million.
- The June 5 ATM filing for $50 million in common stock is now close to half the implied premarket equity value.
Unicycive Therapeutics, Inc. NASDAQ:UNCY dropped in premarket trading Tuesday after the FDA denied approval for its kidney-disease drug again. Investors are now weighing how much of the stock’s value rests on that asset, net of cash.
Nasdaq is open for trading on Tuesday, with standard hours from 9:30 a.m. to 4:00 p.m. ET. Premarket runs from 4:00 a.m. to 9:30 a.m. The exchange lists its next full closure as July 3 for Independence Day observed, according to the 2026 holiday schedule.
Unicycive shares traded at $4.02 in premarket, dropping $3.68, or 47.76%, from where they closed Monday, according to Google Finance. Volume hit 5.78 million shares, well above the 1.27 million average. The outstanding share count was 26.70 million.
| Unicycive trading math | Figure |
|---|---|
| Stock closed Monday | $7.70 |
| Premarket price | $4.02 |
| Premarket loss | 47.76% |
| Total shares | 26.70 mln |
| Equity market cap at $4.02 | ~$107 mln |
| Cash and equivalents | $57.1 mln |
| Equity value less cash | ~$50 mln |
| Premarket trading vs. avg volume | ~4.6x |
The FDA’s letter focused on a third-party manufacturer, Unicycive said. The agency didn’t ask for more clinical or safety data, and raised no red flags about efficacy. Unicycive added that the FDA hadn’t visited the manufacturing vendor during its review of the resubmitted filing. Label negotiations were ongoing as of June 29.
Chief Executive Shalabh Gupta said, “We remain confident in the efficacy and safety of OLC.” Gupta added the company aimed to “expeditiously resubmit the NDA.” Unicycive Therapeutics, Inc.
The distinction is key. If trials had failed, the drug story would have taken a hit. But with a letter focused just on manufacturing, the trade now turns to how long the inspection takes, how much cash burn builds up, and what it costs to keep launch efforts running while the FDA file stays open.
Unicycive reported $57.1 million in unaudited cash, cash equivalents and marketable securities at May 11, saying last month it can fund planned operations into 2027. Around then, Gupta called FDA talks “constructive and timely” as the company got ready for a possible launch. GlobeNewswire
| Regulatory path | Latest confirmed fact |
|---|---|
| Original issue | FDA issued a CRL in June 2025 pointing to problems at a third-party manufacturer |
| Resubmission basis | The company referenced improvements by the vendor and said inspection could resume |
| Latest FDA decision | FDA handed down a second CRL for the same manufacturing problems |
| Clinical package | FDA did not raise issues on efficacy or safety |
| Next variable | Key will be inspection at the vendor and when the NDA goes back in |
The numbers are tighter after that premarket drop. Unicycive moved 3.12 million shares in Q1 using its sales agreement, with an average price of $6.46. Net proceeds came to around $19.6 million after commissions.
The company raised the limit on its ATM program to $150 million on June 5, amending the sales agreement. It also filed a registration for $50 million in common stock under that program. Based on the $4.02 share price, $50 million would be about 12.4 million shares before fees, which is close to 46% of shares outstanding on Google Finance. The company hasn’t said it will sell at that price.
H.C. Wainwright kept a Buy and $22 target on Monday ahead of the CRL, saying earlier the resubmission didn’t carry as much risk because the last letter was about manufacturing, not safety or efficacy. Google Finance showed six analyst calls in the last three months—all Buy—with an average target of $41.50.
| Market reference | Latest cited figure |
|---|---|
| UNCY is trading at $4.02 premarket | $4.02 |
| H.C. Wainwright had a $22 target on UNCY before the CRL | $22 |
| Google Finance shows an average target of $41.50 | $41.50 |
| Google Finance lists $18 as the lowest target | $18 |
| The highest target on Google Finance is $90 | $90 |
Market action was strong outside of the stock in question. The Nasdaq Composite added 2.07% Monday, finishing at 25,820.14. The Russell 2000 also ticked higher to 3,010.42.
Unicycive is developing oxylanthanum carbonate for hyperphosphatemia in chronic kidney disease patients on dialysis. Reuters said Sanofi SA EPA:SAN sells Renvela and Akebia Therapeutics, Inc. NASDAQ:AKBA makes Auryxia, current drugs for these patients, but both involve a high daily pill burden. Unicycive says its OLC drug is made to reduce the number and size of pills.
