Bayer BAYRY announced that it has submitted a new drug application (“NDA”) to the FDA seeking approval for its investigational low-dose gadolinium-based contrast agent (“GBCA”), gadoquatrane, for use in contrast-enhanced magnetic resonance imaging (“MRI”) of the central nervous system and other body regions for adults and pediatric patients, including term neonates.
The proposed dose of 0.04 mmol gadolinium per kilogram (Gd/kg) represents a substantial reduction, approximately 60%, compared to the current standard of care, which is macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight.
Earlier this month, Bayer submitted a marketing authorization application to Japan’s Ministry of Health, Labour and Welfare (“MHLW”) for gadoquatrane. The MRI contrast agent is intended to enhance imaging of suspected or known conditions across all body regions in both adults and pediatric patients, including neonates.
Year to date, shares of Bayer have rallied 58% compared with the industry’s rise of 2.6%.
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Potential Nod to Gadoquatrane to Expand BAYRY's Portfolio
The NDA submission was based on positive data from the pivotal phase III QUANTI studies, which evaluated the safety and efficacy of gadoquatrane in adult and pediatric patients worldwide.
The QUANTI study confirmed that gadoquatrane effectively met both its primary and secondary efficacy endpoints in improving image quality and helping identify lesions during scans. These results support its potential as a reliable contrast agent for accurate diagnosis.
Also, data from the QUANTI Pediatric study, which is part of the QUANTI studies, showed that gadoquatrane behaves the same way in children as it does in adults. It was also found to be generally safe for both age groups, with no new safety concerns reported.
The need for medical imaging is growing, mainly because more people are getting chronic diseases like cancer and heart problems.
If approved, gadoquatrane would become the lowest-dose macrocyclic GBCA to be available in the United States, further strengthening Bayer’s leadership in the field of radiology.
BAYRY's Zacks Rank & Other Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Exelixis EXEL, Amarin Corporation AMRN and Puma Biotechnology PBYI each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have increased 24.2%.
EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.
In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.00 to $2.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $1.78. Year to date, shares of AMRN have surged 38.3%.
AMRN’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 29.11%.
In the past 60 days, estimates for Puma Biotechnology’s earnings per share have increased from 60 cents to 65 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 46 cents to 51 cents. Year to date, shares of PBYI have risen 12.5%.
PBYI’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 171.43%.
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Today, See These 5 Potential Home Runs >>Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report
Exelixis, Inc. (EXEL) : Free Stock Analysis Report
Amarin Corporation PLC (AMRN) : Free Stock Analysis Report
Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
