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RZLT Stock Rises on FDA's Orphan Designation for Rare Disease Drug
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Rezolute, Inc. (RZLT - Free Report) announced that the FDA has granted an Orphan Drug Designation (“ODD”) to its lead pipeline candidate, ersodetug (RZ358), for the treatment of hypoglycemia caused by tumor hyperinsulinism (HI), a rare disease.
Shares of the company were up almost 5% on Dec. 3 following the announcement of the news.
The FDA grants ODD to support the development of medicines for rare disorders that affect a few patients in the United States. The Orphan Drug Designation makes the sponsor eligible to receive seven years of market exclusivity following a potential approval and tax credit for qualified clinical studies, as well as exemptions from certain FDA application fees.
Year to date, shares of Rezolute have surged 439.1% against the industry’s decline of 7%.
Image Source: Zacks Investment Research
More on RZLT's Ersodetug in Tumor HI
The FDA cleared Rezolute’s investigational new drug (IND) application for ersodetug for treating hypoglycemia in patients with tumor HI in August.
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 in the first half of 2025. Top-line data from the same is expected in the second half of 2026.
Recent Developments on RZLT's Ersodetug in Congenital HI
Besides tumor HI, Rezolute is also developing ersodetug for the treatment of hypoglycemia caused by congenital HI, an ultra-rare pediatric genetic disorder.
The FDA removed the partial clinical holds on the phase III sunRIZE study evaluating ersodetug in patients with congenital HI in September.
Enrollment of patients in the sunRIZE study is expected to begin in early 2025 in the United States, with top-line data anticipated in the second half of 2025.
The phase III sunRIZE study evaluating ersodetug in patients with congenital HI was initiated in December 2023.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.9%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 21.1%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 42.6%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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RZLT Stock Rises on FDA's Orphan Designation for Rare Disease Drug
Rezolute, Inc. (RZLT - Free Report) announced that the FDA has granted an Orphan Drug Designation (“ODD”) to its lead pipeline candidate, ersodetug (RZ358), for the treatment of hypoglycemia caused by tumor hyperinsulinism (HI), a rare disease.
Shares of the company were up almost 5% on Dec. 3 following the announcement of the news.
The FDA grants ODD to support the development of medicines for rare disorders that affect a few patients in the United States. The Orphan Drug Designation makes the sponsor eligible to receive seven years of market exclusivity following a potential approval and tax credit for qualified clinical studies, as well as exemptions from certain FDA application fees.
Year to date, shares of Rezolute have surged 439.1% against the industry’s decline of 7%.
Image Source: Zacks Investment Research
More on RZLT's Ersodetug in Tumor HI
The FDA cleared Rezolute’s investigational new drug (IND) application for ersodetug for treating hypoglycemia in patients with tumor HI in August.
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 in the first half of 2025. Top-line data from the same is expected in the second half of 2026.
Recent Developments on RZLT's Ersodetug in Congenital HI
Besides tumor HI, Rezolute is also developing ersodetug for the treatment of hypoglycemia caused by congenital HI, an ultra-rare pediatric genetic disorder.
The FDA removed the partial clinical holds on the phase III sunRIZE study evaluating ersodetug in patients with congenital HI in September.
Enrollment of patients in the sunRIZE study is expected to begin in early 2025 in the United States, with top-line data anticipated in the second half of 2025.
The phase III sunRIZE study evaluating ersodetug in patients with congenital HI was initiated in December 2023.
RZLT's Zacks Rank & Other Key Picks
Rezolute currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the biotech sector are Immunocore Holdings plc (IMCR - Free Report) , Spero Therapeutics, Inc. (SPRO - Free Report) and Castle Biosciences, Inc. (CSTL - Free Report) , 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 Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.9%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 21.1%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 42.6%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.