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September 17, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Secures Exclusive Manufacturing Partnership with Bend Bio Sciences to Support Future Commercialization of Next Generation ADHD Treatment

KANSAS CITY, Kan., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
August 15, 2025 09:00 ET | Source: Cingulate Inc.

Cingulate Provides Management Team Update

Jennifer Callahan, Chief Financial Officer, appointed Interim CEO Board member, Jay Roberts appointed Executive Chairman KANSAS CITY, Kan., Aug. 15, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CING)...
August 06, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
June 03, 2025 08:49 ET | Source: Sixty Degrees Pharmaceuticals

Babesiosis Incidence in U.S. 10x Higher Than CDC Estimates, According to Insurance Claims Study Commissioned by 60 Degrees Pharmaceuticals

Insurance claims show U.S. babesiosis incidence may be 10x CDC estimates; 60 Degrees links chronic fatigue and plans 2026 NDA for tafenoquine treatment.
May 20, 2025 08:00 ET | Source: Cingulate Inc.

Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of CTx-1301 (dexmethylphenidate) for ADHD

Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5New Drug Application on Schedule for this Summer CING CEO Shares Insights and Strategic Outlook on “Unboxing Biotech” Podcast ...
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...
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...
May 01, 2023 07:00 ET | Source: Minerva Neurosciences, Inc

Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

BURLINGTON, Mass., May 01, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central...
August 22, 2022 08:00 ET | Source: Minerva Neurosciences, Inc

Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

WALTHAM, Mass., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central...
January 30, 2019 08:00 ET | Source: IntelGenx Technologies Corp.

IntelGenx Facility Undergoes U.S. FDA Pre-Approval Inspection Related to RIZAPORT® NDA

SAINT LAURENT, Quebec, Jan. 30, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading oral drug delivery company, today announced that the U.S. Food and Drug...