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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...
January 07, 2025 07:30 ET | Source: Cingulate Inc.

Final Study Completed for Cingulate’s Lead Asset CTx-1301

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...
January 06, 2025 08:00 ET | Source: Fortress Biotech, Inc.

Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease

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 ...
September 23, 2024 06:30 ET | Source: XOMA Corporation

Zevra’s MIPLYFFA™ (arimoclomol) Receives Approval from U.S. Food and Drug Administration for Use in Patients with Niemann-Pick Disease Type C (NPC)

MIPLYFFA(TM) becomes 6th commercial asset in XOMA Royalty's portfolio
September 12, 2024 08:30 ET | Source: Cingulate Inc.

Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301

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...
June 25, 2024 09:20 ET | Source: Cingulate Inc.

Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance

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...
May 21, 2024 09:00 ET | Source: Cingulate Inc.

FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD

Phase 3 Data Collected to Date Sufficient for Submission of New Drug Application Advancing Discussions with Commercialization Partners
May 08, 2024 07:00 ET | Source: Cingulate Inc.

Cingulate Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update

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:...
May 07, 2024 08:30 ET | Source: PaxMedica, Inc.

PaxMedica Provides Company Update and Continues to Advance PAX-101 Regulatory Strategy

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...
March 18, 2024 08:30 ET | Source: Journey Medical Corporation

Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea

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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