Optimistic Buy Rating for Regulus Therapeutics’ RGLS8429 Amid Promising ADPKD Treatment Progress

In a report released today, Ram Selvaraju from H.C. Wainwright reiterated a Buy rating on Regulus (RGLS – Research Report), with a price target of $9.00.

Ram Selvaraju has given his Buy rating due to a combination of factors surrounding the progress and potential of Regulus Therapeutics’ RGLS8429 in treating Autosomal Dominant Polycystic Kidney Disease (ADPKD). The advancement of the Phase 1b study to the fourth cohort, with a fixed dose that could inform the design of a pivotal Phase 2 trial, is a key development. Furthermore, Cohort 3’s completion and scheduled reporting of topline data by mid-2024 bolster the optimism for the drug’s prospects. The anticipated end-of-Phase 1 meeting with the FDA before the end of 2024, aimed at preparing for a Phase 2 trial, further reinforces the positive outlook, underpinning the Buy rating and $9 price target.

The decision is also supported by the promising results from Cohort 2, which showed a mechanistic dose response and an inverse correlation between urinary polycystins levels and kidney volume reduction, an approvable endpoint for ADPKD. The observed biological activity and tolerability of RGLS8429, particularly at higher doses, suggest the potential for even greater efficacy in the ongoing Cohort 3. These results indicate that RGLS8429 could potentially proceed to a single Phase 2 pivotal trial under the accelerated approval pathway, justifying the analyst’s positive stance on Regulus’s stock.

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Regulus (RGLS) Company Description:

Regulus Therapeutics, Inc. is a biopharmaceutical company, which engages in the discovery and development of drugs targeting microRNAs. Its two lead product candidates, RG-012 and RGLS4326, are in clinical development. RG-012 is an anti-miR targeting miR-21 in Phase II clinical trial for the treatment of Alport syndrome, a life-threatening kidney disease. RGLS4326 is an anti-miR targeting miR-17 in Phase I clinical trial for the treatment of autosomal dominant polycystic kidney disease. The company is also developing a pipeline of preclinical drug product candidates in renal, hepatic, and central nervous systems diseases. The company was founded in September 2007 and is headquartered in San Diego, CA.