Prévisions

L'objectif de cours moyen des analystes est de 18,99 € (+318,28 %). La médiane est de 18,99 € (+318,28 %).

Acheter	8
Conserver	0
Vendre	0

Actualités Accéder au fil d'actualités

Unicycive Therapeutics loses FDA approval again over manufacturing deficiencies, stock plunges

The FDA issued a second Complete Response Letter for the kidney drug oxylanthanum carbonate (OLC) and rejected approval due to deficiencies at a third-party manufacturer. The agency raised no concerns about OLC’s clinical efficacy or safety, but, because inspections of the supplier are still pending, it did not require additional clinical data. CEO Shalabh Gupta stressed confidence in the drug’s efficacy and safety, while the stock fell about 46% intraday and was trading near its 52-week low. Brokerage H.C. Wainwright remains optimistic but sees increased uncertainty around the timeline for any potential approval. » Plus sur de.investing.com
Unicycive Therapeutics: director Gaurav Aggarwal resigns from supervisory board

Unicycive Therapeutics announced that Gaurav Aggarwal has resigned his seat on the supervisory board. In the mandatory filing with the SEC the company said the resignation was not due to disagreements with Unicycive, management or the supervisory board; no further personnel changes were disclosed. » Plus sur de.investing.com
Unicycive: FDA accepts resubmission of approval application for OLC

Unicycive’s stock rose about 3% after the company said the FDA accepted the resubmission of the New Drug Application for Oxylanthanumcarbonate (OLC) as a Class II complete response. The agency set a six-month review period and a PDUFA target date of June 27, 2026. OLC is an experimental oral phosphate binder to treat hyperphosphatemia in dialysis patients. Unicycive reported $41.3 million in cash at the end of 2025, which the company said should support preparation for a possible launch and funding into 2027. » Plus sur de.investing.com

Données financières de l'entreprise

Au dernier trimestre, UNICYCIVE THERAP. NEW a réalisé un chiffre d'affaires de 0 € et un bénéfice net de -1,51 M €

(EUR)	juin 2026	YoY
Chiffre d'affaires	0	-
Bénéfice brut	0	-
Bénéfice net	-1,51 M	72,42 %
EBITDA	-1,38 M	74,23 %

Données fondamentales

Indicateur	Valeur
Capitalisation boursière	126,75 M €
Nombre d'actions	26,7 M
Plus haut/bas sur 52 semaines	7,54 € - 3,20 €
Dividendes	Non
Bêta	1,78
Ratio P/E	-3,29
Ratio PEG	-0,04
Ratio P/B	2,78
Ratio P/S	0,00

Profil de l'entreprise

Unicycive Therapeutics, Inc. ist ein Biotechnologieunternehmen, das sich in den Vereinigten Staaten mit der Entwicklung neuartiger Therapien für Nierenerkrankungen befasst. Es entwickelt Renazorb zur Behandlung von Hyperphosphatämie bei Patienten mit chronischen Nierenerkrankungen und UNI 494 zur Behandlung von akuten Nierenschäden. Das Unternehmen wurde im Jahr 2016 gegründet und hat seinen Sitz in Los Altos, Kalifornien.