Lantheus Holdings, Inc. recently announced that the FDA has approved the supplemental new drug application for DEFINITY (Perflutren Lipid Microsphere) as an ultrasound-enhancing agent for use in pediatric patients with suboptimal echocardiograms. The approval is expected to provide healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border.

Per the company, clinical studies have substantiated DEFINITY’s efficacy and safety in pediatric patients and represent a significant step forward in pediatric medicine.

The FDA decision was based on usage data from three pediatric clinical trials conducted with DEFINITY — the Golding study, the Fine study and the Kutty study.

The latest regulatory approval is likely to be a significant stepping stone for Lantheus and boost its Precision Diagnostics business.

Significance of the Approval

Per an expert familiar with the use of DEFINITY, the FDA’s latest decision will likely offer a critical diagnostic tool for pediatric heart patients and their families. The approval is expected to offer a valuable alternative to pediatric cardiologists trying to do imaging work in challenging pediatric cardiac cases.

Per management, the expanded indication for DEFINITY is expected to address the unmet medical needs of pediatric patients.

Industry Prospects

Per a report by MarketsandMarkets, the global ultrasound market was valued at $8.5 billion in 2023 and is anticipated to reach $11.6 billion by 2028 at a CAGR of 6.3%. Factors like the increasing patient population, the rising prevalence of chronic diseases and the growing focus on non-invasive procedures are likely to drive the market.

Given the market potential, the latest regulatory clearance is expected to provide a significant boost to Lantheus’ business.

Notable Development

Last month, Lantheus announced its fourth-quarter 2023 results, wherein it registered robust top-line and bottom-line results. The Precision Diagnostics segment recorded a strong performance, which was driven by strength in DEFINITY products. The gross margin expansion was also seen.

Price Performance

Shares of Lantheus have lost 10.5% in the past year against the industry’s 6.9% rise and the S&P 500’s 27.1% growth.

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Zacks Rank & Other Key Picks

Currently, Lantheus carries a Zacks Rank #2 (Buy).

A few other top-ranked stocks in the broader medical space are DaVita Inc. (DVA Quick QuoteDVA - Free Report) , Cardinal Health, Inc. (CAH Quick QuoteCAH - Free Report) and Cencora, Inc. (COR Quick QuoteCOR - Free Report) .

DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 12.1%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 35.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.

DaVita’s shares have gained 56.8% compared with the industry’s 18.9% rise in the past year.

Cardinal Health, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 14.2%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average being 15.6%.

Cardinal Health has gained 50.9% compared with the industry’s 13.7% rise in the past year.

Cencora, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 9.8%. COR’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 6.7%.

Cencora’s shares have rallied 50.7% compared with the industry’s 0.5% rise in the past year.