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May 14, 2025 08:00 ET | Source: Cingulate Inc.

FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301

Pre-NDA Minutes from April 2, 2025, Meeting Received NDA Submission Planned this Summer KANSAS CITY, Kan., May 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical...
May 08, 2025 16:30 ET | Source: Cingulate Inc.

Cingulate Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety Assets

Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025 Non-Dilutive Funding to Accelerate Development of CTx-2103 (buspirone) ...
April 30, 2025 11:00 ET | Source: NeuroSigma, Inc.

NeuroSigma Announces New Clinical Trial of Monarch eTNS System for Treatment of ADHD in Children with Fetal Alcohol Syndrome at UCLA

Trial to be conducted at UCLA and funded by a grant from National Institute on Alcohol Abuse and Alcoholism (NIAAA)First phase of trial will enroll up to 30 children ages 8 – 12 with exposure to...
April 29, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD

Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD KANSAS CITY, Kan., April 29, 2025 (GLOBE NEWSWIRE) --...
April 03, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for lead ADHD Asset CTx-1301

KANSAS CITY, Kan., April 03, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
March 26, 2025 17:00 ET | Source: Cingulate Inc.

Cingulate Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved

In-Person FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-2025$17.5 million increase in Working Capital; Cash Runway Extending into Q4, Well Beyond Target Date for...
March 04, 2025 09:00 ET | Source: Cingulate Inc.

Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025

Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2 CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day KANSAS CITY,...
January 31, 2025 09:00 ET | Source: Focus ADHD Miami

Focus ADHD Launches Virtual ADHD Clinic for Florida Professionals, Now Serving Hialeah and the Greater Miami Area

Miami, Florida, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Focus ADHD Miami, a pioneering virtual psychiatric clinic, today announced the expansion of its specialized adult ADHD treatment services across...
January 22, 2025 09:00 ET | Source: NeuroSigma, Inc.

NeuroSigma Announces Patent Application Protecting Use of Trigeminal Nerve Stimulation to Include Treatment of Dyslexia and Other Neurodevelopmental Disorders

LOS ANGELES, Jan. 22, 2025 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing the Monarch external Trigeminal Nerve Stimulation (eTNS) device for...
January 13, 2025 09:00 ET | Source: NeuroSigma, Inc.

Clinical Trial of NeuroSigma’s Monarch eTNS System for ADHD at King’s College London Completes Enrollment

ATTENS (ADHD trial of external trigeminal nerve stimulation) Project, led by Professor Katya Rubia at the Institute of Psychiatry, Psychology & Neuroscience is a multicentre, double-blind,...

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