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Avenue Therapeutics Announces Agreement with the FDA on the Study Design and Analysis Approach of the Phase 3 Safety Study for IV Tramadol
July 25, 2023 08:30 ET | Avenue Therapeutics
MIAMI, July 25, 2023 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of...
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Cingulate Announces Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD
July 11, 2023 08:00 ET | Cingulate Inc.
KANSAS CITY, Kan., July 11, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
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Cingulate Successfully Manufactures Clinical Supply – Initiation of Pediatric Phase 3 Studies to Commence in July and August
June 29, 2023 08:00 ET | Cingulate Inc.
KANSAS CITY, Kan., June 29, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
BioNTech und OncoC4
BioNTech und OncoC4 starten zulassungsrelevante Phase-3-Studie mit BNT316/ONC-392-Programm bei metastasiertem, nicht-kleinzelligem Lungenkarzinom
June 29, 2023 06:45 ET | BioNTech SE
Der Start der zulassungsrelevanten Phase-3-Studie für nicht-kleinzelliges Lungenkarzinom ist ein wichtiger erster Schritt in BioNTechs und OncoC4s strategischer Kollaboration, die im März 2023...
BioNTech and OncoC4
BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC
June 29, 2023 06:45 ET | BioNTech SE
 Initiation of pivotal Phase 3 trial in non-small cell lung cancer (NSCLC) marks the first landmark in BioNTech’s and OncoC4’s strategic collaboration initiated in March 2023 with the aim to evaluate...
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Cingulate Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD
June 08, 2023 07:00 ET | Cingulate Inc.
Study Assessed Onset and Duration of CTx-1301 in Adults, Results Expected 3Q 2023 Pivotal Phase 3 Trials in Pediatric/Adolescent Patients on Schedule for 3Q 2023 Initiation KANSAS CITY, Kan., June ...
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Synlogic Announces Initiation of Synpheny-3 Global, Pivotal Phase 3 Study Evaluating SYNB1934 for Treatment of Phenylketonuria
June 05, 2023 06:45 ET | Synlogic, Inc.
Registrational study designed to support BLA submission of first-in-class biotherapeutic Company further streamlining organization to focus resources on execution of late clinical-stage programs in...
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Cingulate to Present at 13th Annual LD Micro Invitational
May 25, 2023 15:55 ET | Cingulate Inc.
KANSAS CITY, Kan., May 25, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...
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Cingulate Inc. Reports First Quarter 2023 Financial Results and Provides Clinical and Business Update
May 10, 2023 16:15 ET | Cingulate Inc.
Additional $3 Million of Financing Proprietary PTR™ Manufacturing Processes Successfully Transferred to Societal CDMO Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301 KANSAS...
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Arcutis Completes Enrollment in INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
May 02, 2023 08:00 ET | Arcutis Biotherapeutics, Inc.
A total of 652 children, ages 2 to 5, were enrolled in the studyTopline data expected in the third quarterAtopic dermatitis (AD) affects approximately 26 million adults and children in the United...