Rezolute Receives Innovation Passport Designation From The U.K. Innovative Licensing And Access Pathway Steering Group For RZ358 In The Treatment Of Hypoglycemia Due To Congenital Hyperinsulinism
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Rezolute, Inc. (NASDAQ:RZLT) has been awarded the Innovation Passport by the U.K. MHRA for RZ358, aimed at treating hypoglycemia due to congenital hyperinsulinism (HI). This designation, based on the Phase 2 RIZE study results, is the first step in the ILAP process, which aims to expedite market access for new medicines. RZ358, a monoclonal antibody, has shown significant improvements in hypoglycemia events and is well-tolerated. It has also received Orphan Drug and Pediatric Rare Disease Designations in the U.S. and PRIME designation by the EMA.
January 23, 2024 | 1:17 pm
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Rezolute's RZ358 has been granted the Innovation Passport by the U.K. MHRA, indicating a positive regulatory development and potential for accelerated market access in the U.K. for the treatment of congenital hyperinsulinism.
The Innovation Passport is a significant regulatory milestone that can lead to accelerated market access and increased investor confidence in the company's pipeline. The positive results from the Phase 2 RIZE study and the potential to address a substantial unmet medical need contribute to the likelihood of a positive short-term impact on RZLT's stock price.
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