UNCY, US90466Y2028

Unicycive Therapeutics stock gets a new director as FDA review advances

Published on 10/04/2026 at 21:57 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Unicycive Therapeutics stock closed at USD 4.22 on October 2, 2026, after a new board appointment. The Q2 loss was USD 0.06 per share.

UNCY, US90466Y2028, Illustration mit AI erstellt.

Unicycive Therapeutics (ISIN US90466Y2028) stock closed at USD 4.22 on Nasdaq on October 2, 2026, down 7.25 percent from the previous close. On October 1, the company appointed Meredith Manning to its board as it prepares for a potential transition toward commercial operations, according to Globe Newswire.

NDA resubmission sets the next milestone

Unicycive resubmitted its New Drug Application for oxylanthanum carbonate on September 29, 2026. The treatment is an investigational oral phosphate binder for hyperphosphatemia in patients with chronic kidney disease who are on dialysis.

In the company release, Unicycive Therapeutics said the package includes chemistry, manufacturing and controls data from a new vendor, 12 months of drug-product stability data and additional bridging data between the vendors. The company anticipates FDA acceptance within 30 days of the resubmission and a new PDUFA date six months after resubmission, making manufacturing execution the key regulatory checkpoint.

Loss narrows while cash funds preparation

For the quarter ended June 30, 2026, Unicycive reported a net loss of USD 1.7 million, or USD 0.06 per share, compared with a USD 6.5 million loss, or USD 0.52 per share, in the prior-year quarter, according to StockTitan.

The company reported USD 61.4 million in cash, cash equivalents and marketable securities as of June 30, 2026, with a stated runway into the second half of 2027. That liquidity gives the NDA process more time, but the product still requires FDA acceptance and approval before commercial revenue can begin.

Analyst target stays far above price

MarketBeat lists a Moderate Buy consensus from seven analysts, with five Buy ratings, one Hold and one Sell. The average 12-month target is USD 18.25, while the published high and low targets are USD 25.00 and USD 13.00, respectively, according to MarketBeat. The average target lies 332.5 percent above the October 2 price.

The bullish consensus has become more cautious at the individual-firm level. H.C. Wainwright maintained a Buy rating but cut its target from USD 15.00 to USD 13.00 on September 29, 2026, according to Markets Insider.

Stock remains near its yearly low

At USD 4.22 on October 2, 2026, Unicycive shares stood 51.72 percent below the 52-week high of USD 8.74 and above the 52-week low of USD 3.93. The stock's market capitalization was USD 117.5 million and volume reached 1,500,000 shares.