Rezolute Gets US FDA Approval for IND Application for RZ358 to Treat Hypoglycemia Caused by Tumor Hyperinsulinism-March 2024-www.financetom.com

Rezolute Gets US FDA Approval for IND Application for RZ358 to Treat Hypoglycemia Caused by Tumor Hyperinsulinism

News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities

Rezolute Gets US FDA Approval for IND Application for RZ358 to Treat Hypoglycemia Caused by Tumor Hyperinsulinism

Aug 5, 2024 8:18 AM

10:59 AM EDT, 08/05/2024 (MT Newswires) -- Rezolute ( RZLT ) said Monday it has obtained US Food and Drug Administration clearance for an investigational new drug application for a phase 3 trial of RZ358 intended to treat hypoglycemia in people with tumor hyperinsulinism.

The company said it is launching start-up activities for the phase 3 trial, which will be mainly conducted in the US, with patient enrollment expected to begin in H1 2025.

RZ358 is also being assessed in an ongoing phase 3 study in people with congenital hyperinsulinism, Rezolute ( RZLT ) said, adding topline results from that study are expected in the middle of next year.

Shares of Rezolute ( RZLT ) were down more than 6% in recent trading activity.

Price: 4.03, Change: -0.27, Percent Change: -6.33

Previous page： Bally's to Merge with Standard General in $4.6 Billion Deal; Shares Jump Pre-Bell Next page： --B. Riley Adjusts Century Communities' PT to $113 From $110, Maintains Buy Rating

Comments

Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.

Show More Comments

Related Articles >

Bally's to Merge with Standard General in $4.6 Billion Deal; Shares Jump Pre-Bell

Jul 25, 2024

08:32 AM EDT, 07/25/2024 (MT Newswires) -- Bally's (BALY) said Thursday it has entered into a merger agreement with Standard General to sell its outstanding shares at $18.25 per share. The deal values Bally's at about $4.6 billion, the company said. Bally's shareholders can opt for cash or retain a portion or all of their shares through a rollover election....

--B. Riley Adjusts Century Communities' PT to $113 From $110, Maintains Buy Rating

Jul 25, 2024

08:38 AM EDT, 07/25/2024 (MT Newswires) -- Price: 100.67, Change: +4.05, Percent Change: +4.19 ...

Carpenter Technology's Fiscal Q4 Adjusted Earnings, Net Sales Rise; Board Authorizes Up to $400 Million Share Buyback Plan

Jul 25, 2024

08:39 AM EDT, 07/25/2024 (MT Newswires) -- Carpenter Technology ( CRS ) reported fiscal Q4 adjusted earnings Thursday of $1.82 per diluted share, up from $0.78 a year earlier. Analysts polled by Capital IQ expected $1.51. Net sales for the quarter ended June 30 were $798.7 million, up from $758.1 million a year earlier. Four analysts surveyed by Capital IQ...

Ryder System Q2 Non-GAAP EPS Falls, Revenue Increases; Q3 Outlook Issued, 2024 Guidance Adjusted

Jul 25, 2024

08:31 AM EDT, 07/25/2024 (MT Newswires) -- Ryder System (R) reported Q2 comparable earnings from continuing operations, a non-GAAP measure, Thursday of $3 per diluted share, down from $3.61 a year earlier. Analysts polled by Capital IQ expected $2.87. Revenue for the quarter ended June 30 was $3.18 billion, up from $2.88 billion a year earlier. Analysts surveyed by Capital...