Brief: Unicycive Therapeutics Reaches Alignment with the FDA on Path to File New Drug Application for Oxylanthanum Carbonate

Unicycive Therapeutics

23/10/2023 12:44

Oct 23 (Reuters) - Unicycive Therapeutics Inc  UNCY.O :
    * UNICYCIVE THERAPEUTICS REACHES ALIGNMENT WITH THE FDA ON
PATH TO
FILE NEW DRUG APPLICATION FOR OXYLANTHANUM CARBONATE (OLC)
    * UNICYCIVE THERAPEUTICS INC - PIVOTAL CLINICAL TRIAL
EXPECTED TO
INITIATE BEFORE YEAR END
    * UNICYCIVE THERAPEUTICS INC - AS OF JUNE 30, UNICYCIVE'S
CASH
POSITION WAS REPORTED AS $18.8 MILLION WHICH IS EXPECTED TO LAST
INTO SECOND HALF OF 2024
    * UNICYCIVE THERAPEUTICS INC - EXPECT TO INITIATE PIVOTAL
TRIAL
FOR OLC BEFORE END OF THIS YEAR, WITH TOP LINE DATA EXPECTED IN
Q2 OF 2024
    * UNICYCIVE: FDA AGREES WITH CO'S STUDY DESIGN OF 60
PARTICIPANTS
TO BE TESTED FOR 4 WEEKS ON OLC ONCE PARTICIPANTS TITRATED TO
CLINICALLY EFFECTIVE DOSES

Source text for Eikon:  ID:nGNX6pKs1p 
Further company coverage:  UNCY.O 

 ((Reuters.Briefs@thomsonreuters.com;))