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October 23, 2025 08:45 ET | Source: Biofrontera Inc.

Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG

Biofrontera Inc. acquires full U.S. rights to Ameluz® and RhodoLED®, including New Drug Application and associated patents, from former parent Biofrontera AG.New earnout structure reduces payment rate...
October 21, 2025 09:00 ET | Source: Dewpoint Therapeutics

Dewpoint Therapeutics Announces an Open IND for First-in-Class Condensate Modulator DPTX3186 for Wnt-Driven Cancers

Dewpoint Therapeutics today announced the opening of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for DPTX3186.
October 02, 2025 08:00 ET | Source: PharmaTher Holdings Ltd.

PharmaTher Provides Corporate Update on Ketamine Development and Commercial Strategy

TORONTO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the...
August 19, 2025 08:45 ET | Source: Cingulate Inc.

Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights

Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026 KANSAS CITY, Kan., Aug. 19,...
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...
July 15, 2025 07:01 ET | Source: Sixty Degrees Pharmaceuticals

60 Degrees Pharmaceuticals Defines Potential Human Babesiosis Market Size for ARAKODA® (tafenoquine): Annual Max TAM, Sales of $245 Million; Cumulative through Patent Expiration, $1.1 Billion

60 Degrees sets human babesiosis TAM for ARAKODA at $245M annually, $1.1B total through 2035; NDA planned for 2026 pending trial data.
July 09, 2025 08:00 ET | Source: Cingulate Inc.

Cingulate Appoints Nilay Patel as Chief Legal Officer to Support Growth ahead of New Drug Application

KANSAS CITY, Kan., July 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
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...
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...