Leerink bullish on Regulus, initiates with an Outperform

As previously reported, Leerink initiated coverage of Regulus with an Outperform rating and $6 price target. The firm notes the company’s lead asset RGLS8429 is a next-generation oligonucleotide targeting miR-17, currently progressing in a Phase 1b study. Data from the first two cohorts of the Phase 1b trial for RGLS8429 confirm target engagement via biomarkers, as well as early positive signals on kidney endpoints, including height-adjusted total kidney volume/HtTKV and estimated glomerular filtration rate/eGFR, Leerink adds. Moreover, management has confirmed with the FDA that an Accelerated Approval pathway is a possibility, which may allow for rapid development in this blockbuster indication. With Cohort 3 data expected in mid-2024 and regulatory interactions planned for Q4 2024, the firm thinks Regulus shares can continue to move higher as investors learn about RGLS8429’s potential to become a valuable disease-modifying treatment for ADPKD.