New York, June 4, 2026, 07:08 EDT
- Unicycive shares traded at $7.20 ahead of the U.S. market open, off 0.4%. The company’s market cap was about $172 million.
- Benchmark raised its price target on the stock to $18 from $15. The FDA decision due June 29 is still the key near-term catalyst for shares.
- The company is getting ready for a possible launch of oxylanthanum carbonate, which is a phosphate binder used by dialysis patients.
Unicycive Therapeutics shares didn’t move much in premarket trading Thursday. Benchmark lifted its price target, but attention stayed on an upcoming U.S. regulatory decision expected this month.
The Nasdaq-listed kidney-drug maker traded at $7.20 by 6:34 a.m. EDT, off 0.4% from its last close. At the same time, the SPDR S&P Biotech ETF, a common biotech benchmark, was up 1.6% in early moves.
Unicycive’s timing is key. The company’s main drug, oxylanthanum carbonate (OLC), is before the U.S. Food and Drug Administration for hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA’s PDUFA date is June 29, Unicycive said.
Benchmark lifted its price target on Unicycive to $18 from $15 and stuck with its Speculative Buy call, TipRanks said, citing The Fly. Benchmark noted its model does not factor in any upside from UNI-494, which is Unicycive’s program for acute kidney injury.
Another upbeat note from the sell side landed as well. TipRanks reported H.C. Wainwright’s Swayampakula Ramakanth kept his Buy rating and $22 price target, pointing to lessened OLC risk thanks to better manufacturing and talks with the FDA on labeling.
Unicycive hasn’t put out a company update since May 12, when its first-quarter report said the FDA review was still on schedule and work for commercial launch was ongoing. The most recent quarterly filing is also from May 12.
Chief Executive Shalabh Gupta said in the update that talks with the FDA in the review cycle have been “constructive and timely.” Gupta said OLC may “improve adherence and phosphorus control” by reducing the number of pills compared with current phosphate binders. Unicycive Therapeutics, Inc.
Unicycive said it held $57.1 million in cash, cash equivalents and marketable securities as of May 11. The company said it expects this to cover planned operations into 2027. First-quarter research and development expense was $1.6 million. General and administrative expense was $6.8 million.
Ardelyx’s Xphozah is already on the market in the U.S., cleared to lower serum phosphorus for adults with chronic kidney disease on dialysis when binders fail or aren’t an option. Akebia’s Auryxia, or ferric citrate, is on label to control serum phosphorus in adult dialysis patients too. The bar for competition is public.
Payment rules also factor into the market test, not just FDA approval. CMS said oral-only renal dialysis drugs will shift to the ESRD prospective payment system, or Medicare dialysis bundle, starting Jan. 1, 2025. Phosphate binders get a transitional add-on payment for at least two years, before CMS reviews any base rate changes.
That setup cuts both ways. Any setback—like an FDA delay or rejection, fresh manufacturing problem, or slower uptake under dialysis pay rules—could slam the stock. Unicycive is still small, posting losses, and its short-term pitch rests on this one drug call.
The stock has climbed roughly 25% this year to $7.20, per MarketBeat, after opening 2026 at $5.77. That run doesn’t leave much cushion if the late-June catalyst disappoints.
