Bayer (OTCMKTS: BAYRY) has announced that the FDA has accepted its New Drug Application for gadoquatrane, a next-generation gadolinium-based contrast agent for MRI imaging across the central nervous system and other parts of the body, including in pediatric and neonatal patients.
What makes gadoquatrane stand out? It’s formulated at just 0.04 mmol Gd/kg—a 60% reduction in gadolinium compared to typical macrocyclic agents used today. Data from the Boehringer Phase III QUANTI program—including studies in adults (CNS and non-CNS) and children—demonstrated strong efficacy on lesion visualization and detection, plus a clean safety profile with no new adverse signals across all age groups.
Additionally, Bayer has parallel regulatory submissions in motion across Japan, the EU, and other markets, with further applications planned globally.
Why It Matters to Investors: If approved, gadoquatrane could redefine the contrast media landscape by delivering high-quality MRI imaging with significantly lower gadolinium exposure—a major advantage for patients requiring repeated imaging, such as those with chronic conditions. The FDA’s acceptance accelerates Bayer’s path to launch, and the global regulatory traction signals meaningful commercial upside ahead.
The post Bayer’s Gadoquatrane: FDA Review Underway and Positioned as a Low-Dose MRI Game-Changer appeared first on PRISM MarketView.
