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Wednesday, January 29, 2025

'Regulus Positive Clinical, Regulatory Updates in Polycystic Kidney Disease Program'

 Topline data from an interim analysis of the fourth cohort of its Phase 1b Multiple-Ascending Dose (MAD) clinical trial showed continued mechanistic dose response

Exploratory results of imaging-based biomarkers continued to show reduction in height-adjusted total kidney volume (htTKV) growth rate

Successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) with agreement on key components of a Phase 3 single pivotal trial for potential Accelerated Approval

Company to hold conference call at 8:30 a.m. ET today

The Company will host a conference call and live audio webcast on Wednesday, January 29 at 8:30 am Eastern Time. To access the call, please dial (833) 816-1394 (domestic) or (412) 317-0487 (international).  To access the telephone replay of the call, dial (877) 344-7529 (domestic) or (412) 317-0088 (international), passcode ID 1454429.  The webcast and telephone replay will be archived on the Company's website at www.regulusrx.com following the call.

https://www.prnewswire.com/news-releases/regulus-therapeutics-announces-positive-clinical-and-regulatory-updates-from-its-autosomal-dominant-polycystic-kidney-disease-adpkd-program-for-farabursen-rgls8429-302362731.html

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