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Final Study Completed for Cingulate’s Lead Asset CTx-1301
07. Januar 2025 07:30 ET | Cingulate Inc.
No Serious Adverse Events ReportedSubmission of New Drug Application Targeted for Mid 2025 KANSAS CITY, Kan., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical...
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Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
06. Januar 2025 08:00 ET | Fortress Biotech, Inc.
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones ...
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Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301
12. September 2024 08:30 ET | Cingulate Inc.
KANSAS CITY, Kan., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
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Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance
25. Juni 2024 09:20 ET | Cingulate Inc.
Twelve Required Registration Batches CompletedNew Drug Application Being Prepped for Submission KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- In alignment with U.S. Food and Drug...
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FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD
21. Mai 2024 09:00 ET | Cingulate Inc.
Phase 3 Data Collected to Date Sufficient for Submission of New Drug Application Advancing Discussions with Commercialization Partners
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Cingulate Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update
08. Mai 2024 07:00 ET | Cingulate Inc.
CTx-1301 on track to file for Marketing Approval with FDA in 1H 2025 Increase of $10 Million in Stockholders’ Equity KANSAS CITY, Kan., May 08, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:...
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PaxMedica Provides Company Update and Continues to Advance PAX-101 Regulatory Strategy
07. Mai 2024 08:30 ET | PaxMedica, Inc.
TARRYTOWN, New York, May 07, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica, Inc. (OTC:PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, provided a...
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Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
18. März 2024 08:30 ET | Journey Medical Corporation
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily...
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Catalyst Pharmaceuticals Announces AGAMREE® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (DMD)
13. März 2024 07:55 ET | Catalyst Pharmaceuticals, Inc.
AGAMREE® (vamorolone) a Novel Alternative Corticosteroid with Demonstrated Properties in Maintaining Efficacy and a Well-Tolerated Side Effect Profile Available in the U.S. by Prescription for...