NeuroBo Pharmaceuticals, Inc., publicly traded under the symbol NRBO, announced that the US Food and Drug Administration (FDA) has approved its application for the Investigational New Drug, referred to as DA-1726. This particular drug is a dual oxyntomodulin analog agonist.
The company projected that DA-1726 will serve as an agonist for both the glucagon-like peptide-1 receptor and the glucagon receptor. Following this announcement, the company's shares skyrocketed 28% in pre-market trading.
NeuroBo also shared plans to initiate a Phase 1 clinical trial intended to address obesity, set to begin in the first half of the current year. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of both single and multiple increasing doses of DA-1726 in obese yet otherwise healthy subjects.
The primary objective of this trial will be to monitor the safety and tolerability of DA-1726 by keeping track of any adverse events—including serious adverse events, treatment-emergent adverse events, and AEs leading to treatment discontinuation. The biotechnology firm in the clinical stage expects the first patient to receive DA-1726 in the first half of this year.
In pre-market transactions on the Nasdaq, the shares were valued at $4.19, showing an upward trend with a 28.13% increase.