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December 29, 2025 08:00 ET | Source: Praxis Precision Medicines, Inc.

Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor

The Breakthrough Therapy Designation was granted based on the positive topline results from the Essential3 Phase 3 program in essential tremor Praxis remains on track to submit ulixacaltamide NDA in...
January 04, 2022 07:00 ET | Source: Cullinan Oncology, Inc.

FDA Grants Breakthrough Therapy Designation for Cullinan Oncology’s CLN-081 in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

CAMBRIDGE, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), a biopharmaceutical company focused on developing a diversified pipeline of targeted...