Shares of Rezolute RZLT have rallied 30.8% in the past six months against the industry’s decline of 4.1%, driven by investor enthusiasm about the company’s encouraging progress with the development activities for its lead pipeline candidate, ersodetug (RZ358).

Rezolute is a late-stage clinical biotech focused on improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI).

The company is evaluating ersodetug in the phase III sunRIZE study for treating patients with congenital HI, an ultra-rare pediatric genetic disorder.

Factors Driving RZLT Stock Price

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Earlier this week, the company announced outcomes from the open label arm (OLA) portion of the phase III sunRIZE study.

An independent Data Monitoring Committee (DMC) reviewed the OLA of the sunRIZE study, which evaluated ersodetug in eight infants aged between three months to one year for treating congenital HI. Per the DMC review, treatment with ersodetug was generally safe and well-tolerated in the given patient population. The DMC also approved the enrollment of subsequent infants into the double-blind portion of the study.

Enrollment of participants in the sunRIZE study is expected to be completed in the second quarter of 2025, with top-line data anticipated in the fourth quarter of 2025.

The FDA granted a Breakthrough Therapy designation to ersodetug for the treatment of hypoglycemia due to congenital HI in January 2025.

The FDA removed the partial clinical hold on the phase III sunRIZE study evaluating ersodetug in patients with congenital HI in September 2024.

RZLT Developing Ersodetug in Tumor HI Too

Besides congenital HI, Rezolute is also developing ersodetug for the treatment of hypoglycemia caused by tumor HI, a rare disease.

The company is currently gearing up for start-up activities for the phase III registrational study evaluating ersodetug in patients with tumor HI. Enrollment of patients in the study is expected to begin later in the first half of 2025. Top-line data from the same is expected in the second half of 2026.

The FDA granted an Orphan Drug designation to ersodetug for treating hypoglycemia caused by tumor HI in December 2024.

In August 2024, the FDA cleared Rezolute’s investigational new drug application for ersodetug for treating hypoglycemia in patients with tumor HI.

The successful development of ersodetug, with some clinical milestones expected later in the year, should continue the upward momentum for the stock in 2025.

RZLT's Zacks Rank & Stocks to Consider

Rezolute currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Harmony Biosciences Holdings, Inc. HRMY, Castle Biosciences, Inc. CSTL and BioMarin Pharmaceutical Inc. BMRN, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Harmony Biosciences’ earnings per share have increased from $2.64 to $3.22 for 2025. In the past year, shares of HRMY have rallied 23.4%.

HRMY’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 147.24%.

In the past 60 days, estimates for Castle Biosciences’ 2025 loss per share have narrowed from $1.84 to $1.70. In the past year, shares of CSTL have increased 19.8%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

In the past 60 days, estimates for BioMarin’s earnings per share have moved up from $3.94 to $4.01 for 2025. In the past year, shares of BMRN have plunged 28.4%.

BMRN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 28.70%.

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