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Rezolute (RZLT) Posts Positive Data From Congenital HI Study

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Rezolute, Inc. (RZLT - Free Report) announced positive data from the phase IIb RIZE study, which is evaluating its lead pipeline candidate RZ358 for the treatment of congenital hyperinsulinism (HI), the most common cause of recurrent hypoglycemia in children.

The multicenter, open label phase IIb RIZE study investigated the safety, tolerability, pharmacokinetics and glycemic efficacy of RZ358 in patients with congenital HI whose hypoglycemia was not adequately controlled on standard of care therapies. Data from the same showed that treatment with RZ358 led to highly significant improvements in hypoglycemia levels in the given patient population.

The data demonstrated the safety and tolerability of RZ358 in patients with congenital HI.

Shares of Rezolute were up 7.3% on Wednesday following the announcement of the news. However, the stock has dropped 17.4% so far this year compared with the industry’s decline of 12.2%.

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RZLT remains focused on taking RZ358, a monoclonal antibody, into the phase III development for treating congenital HI, a rare pediatric endocrine disorder.

The FDA granted an Orphan Drug Designation as well as a Pediatric Rare Disease Designation to RZ358 for the treatment of congenital HI. The candidate also enjoys an Orphan Drug Designation in the European Union for the given indication.

Apart from RZ358, Rezolute is developing RZ402, a plasma kallikrein inhibitor (PKI), as an oral therapy for the treatment of diabetic macular edema (DME).

In February 2022, RZLT announced positive topline data from a phase Ib multiple-ascending dose or MAD study, which is evaluating RZ402 for treating DME. Treatment with RZ402 was generally safe and well-tolerated.

Rezolute is planning to initiate a phase II proof-of-concept study on RZ402 in the second half of 2022.

RZLT currently has no approved product in its portfolio. A successful development of RZ358 and another pipeline candidate RZ402 remains in key focus.

Zacks Rank & Stocks to Consider

Rezolute currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Athersys, Inc. (ATHX - Free Report) , Kaleido Biosciences, Inc. and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Athersys’ earnings estimates have been revised 21.7% upward for 2022 over the past 60 days.

Earnings of ATHX surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.

Kaleido Biosciences’ loss per share estimates have narrowed 23% for 2022 over the past 60 days.

Earnings of KLDO surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion.

Vertex’s earnings estimates have been revised 8.7% upward for 2022 over the past 60 days. The VRTX stock has increased 13% year to date.

Earnings of Vertex surpassed estimates in each of the trailing four quarters.


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