9 Meters Biopharma Announces Successful Pre-IND Meeting with FDA Regarding Its GIP Antagonist NM-136 for Obesity
9 Meters Biopharma, Inc. (NMTR)
Company Research
Source: Accesswire
RALEIGH, NC / ACCESSWIRE / April 5, 2023 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, today announced receipt of a written response from the U.S. Food and Drug Administration (FDA) on the request for a Type B pre-IND (Investigational New Drug) meeting on the planned pre-clinical development of NM-136 for the treatment of obesity. Based on the response, the Company currently plans to submit an IND to the FDA for this indication in the second half of 2023 based on the completion of the preclinical program. An approved IND is a prerequisite for conducting Phase 1 clinical studies of NM-136 in the U.S.Completion of this interaction with the FDA represents an important milestone and provides greater regulatory clarity and direction on the data needed to support an IND submission including input on the nonclinical plans and a proposed design of the Phase 1 study."We are pleased with th
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