CERo Therapeutics Secures FDA Fast Track Designation for CER-1236 in Acute Myeloid Leukemia, Enhancing Regulatory and Financial Pathways

Reuters
Sep 05
CERo <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Secures FDA <a href="https://laohu8.com/S/FTRK">Fast Track</a> Designation for CER-1236 in Acute Myeloid Leukemia, Enhancing Regulatory and Financial Pathways

Cero Therapeutics Holdings Inc. has received a significant regulatory boost as the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its lead investigational compound, CER-1236, aimed at treating Acute Myeloid Leukemia (AML). This designation, which is in addition to an existing Orphan Drug Designation, underscores the urgency of addressing AML and the promise seen in CER-1236's data. The Fast Track status will accelerate the development and review process, allowing for increased interaction with the FDA, potential eligibility for priority review, and the ability to submit data on a rolling basis. This milestone is part of an ongoing Phase 1/1b study evaluating the safety and efficacy of CER-1236 in various AML patient groups.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cero Therapeutics Holdings Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9523944-en) on September 05, 2025, and is solely responsible for the information contained therein.

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