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25 juin 2024 09h20 HE | 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...
21 mai 2024 09h00 HE | 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
08 mai 2024 07h00 HE | 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:...
07 mai 2024 08h30 HE | 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...
18 mars 2024 08h30 HE | 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...
13 mars 2024 07h55 HE | Source: Catalyst Pharmaceuticals, Inc.

Catalyst Pharmaceuticals Announces AGAMREE® Now Commercially Available in the U.S. for the Treatment of Duchenne Muscular Dystrophy (DMD)

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...
18 déc. 2023 06h30 HE | Source: Catalyst Pharmaceuticals, Inc.

Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner DyDo Pharma

CORAL GABLES, Fla., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing,...
24 nov. 2023 16h10 HE | Source: The Rosen Law Firm PA

AXSM FINAL DEADLINE ALERT: ROSEN, A LEADING LAW FIRM, Encourages Axsome Therapeutics, Inc. Investors to Secure Counsel Before Important December 7 Deadline in Securities Class Action – AXSM

NEW YORK, Nov. 24, 2023 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds investors of the common stock of Axsome Therapeutics, Inc. (“Axsome”) (NASDAQ: AXSM) of...
09 août 2023 16h17 HE | Source: Catalyst Pharmaceuticals, Inc.

Catalyst Pharmaceuticals Reports Strong Second Quarter 2023 Financial Results and Provides Corporate Update

Achieved Record Q2 2023 Total Net Revenues of $99.6 MillionAchieved FIRDAPSE® 2023 Second Quarter Net Revenues of $64.9 Million, a 22% Increase YOYAchieved 2023 Second Quarter GAAP EPS Diluted of...
17 juil. 2023 09h00 HE | Source: Elevar Therapeutics

Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma

FORT LEE, N.J., July 17, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., and a fully integrated biopharmaceutical company dedicated to elevating...

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