Brief: Cingulate Says Got Guidance From U.S. FDA Regarding Clinical Program For Ctx-1301

Cingulate

28/12/2023 11:15

Dec 28 (Reuters) - Cingulate Inc  CING.O :
    * CINGULATE INC - RECEIVED GUIDANCE FROM U.S. FOOD AND DRUG
ADMINISTRATION (FDA) REGARDING ITS CLINICAL PROGRAM FOR CTX-1301
    * CINGULATE INC - EXPECT TO SUBMIT NDA FOR CTX-1301 IN FIRST
HALF
OF 2025
    * CINGULATE INC: IN ORDER TO ACHIEVE FILING OF OUR NDA FOR
CTX-1301 FOR POTENTIAL FDA APPROVAL, BELIEVE WE WILL NEED ABOUT
$17-21 MILLION OF CAPITAL
    * CINGULATE INC - STOPPED ENROLLMENT IN PIVOTAL PHASE 3
FIXED-DOSE
PEDIATRIC AND ADOLESCENT SAFETY AND EFFICACY STUDY THAT
COMMENCED IN LATE JULY 2023
    * CINGULATE INC -  STOPPED ENROLLMENT IN PHASE 3 PEDIATRIC
DOSE-OPTIMIZATION ONSET AND DURATION STUDY THAT COMMENCED IN
EARLY AUGUST 2023
    * CINGULATE INC: NEED FOR ABOUT $17-21 MILLION OF CAPITAL IS
APPROXIMATELY $9-13 MILLION LESS THAN INITIALLY ANTICIPATED
    * CINGULATE- WE PLAN TO INITIATE  CLINICAL PLAN FOR CTX-1302
(DEXTROAMPHETAMINE), SECOND INVESTIGATIONAL ASSET FOR TREATMENT
OF ADHD, AS SOON AS 2025
    * CINGULATE INC: ON DECEMBER 26, CO  RECEIVED A LETTER FROM
THE
LISTING QUALIFICATIONS STAFF OF THE NASDAQ STOCK MARKET
    * CINGULATE-ARE IN LICENSE CONVERSATIONS & PENDING
DEFINITIVE
DEAL, DEVELOPMENT OF CTX-2103 (BUSPIRONE) FOR TREATMENT OF
ANXIETY MAY BEGIN IN 2025
    * CINGULATE: LETTER STATES CO NO LONGER COMPLY WITH NASDAQ’S
DIRECTOR AND COMMITTEE REQUIREMENTS

Further company coverage:  CING.O 

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