On Monday, Jones Trading reiterated its Buy rating on shares of Regulus (NASDAQ:RGLS) Therapeutics (NASDAQ:RGLS), maintaining a price target of $8.00. The firm's stance comes after Regulus released topline results from Phase 1b Cohort 3 studies focusing on the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
The analyst from Jones Trading addressed the recent decline in Regulus's stock price, attributing it to investor concerns regarding dose response, the efficacy of the treatment measured by eGFR benefit, and the degree of reduction in height-adjusted total kidney volume (htTKV) when compared to Cohort 2. Despite these concerns, the analyst emphasized the positive outcomes observed, noting that the drug RGLS8429 demonstrated significant and swift reductions in htTKV, which were in line with increases in urinary PC1/PC2 biomarkers.
The data from Cohort 3 were highlighted as confirming the ability of RGLS8429 to reduce, and potentially even reverse, kidney growth. The analyst mentioned that the plateau observed between dosages of 2mg/kg and 3mg/kg was anticipated, given that the predicted optimal dose is 2.4 mg/kg. This detail was provided to assuage doubts about the drug's efficacy at varying doses.
Looking ahead, the next significant update from Regulus is expected to be the fixed dose data, which will be available in late 2024 or early 2025. Jones Trading's continued support for Regulus is reflected in the reiterated Buy rating and $8 price target, signaling confidence in the company's ongoing research and potential for future success.
In other recent news, Regulus Therapeutics Inc . reported positive topline results from a Phase 1b trial of RGLS8429, a potential treatment for autosomal dominant polycystic kidney disease (ADPKD). The trial demonstrated a dose response in urinary biomarkers and a reduction in kidney volume in a majority of patients at the 3 mg/kg dose level. The 3 mg/kg dose showed statistical significance in the change from baseline in urinary polycystins 1 and 2 (PC1 and PC2), which are inversely correlated with disease severity.
Further, magnetic resonance imaging (MRI) analyses indicated a reduction in total kidney volume in 70% of patients treated with the 3 mg/kg dose. Regulus has commenced enrollment for the fourth cohort of the study, which will involve a fixed dose of 300 mg of RGLS8429 administered every other week for three months.
The company's President and Head of Research & Development, Preston Klassen, M.D., expressed satisfaction with the consistent response and safety profile observed. CEO Jay Hagan reinforced the company's confidence in the treatment's ability to address the genetic cause of ADPKD. Regulus anticipates an End-of-Phase 1 meeting with the FDA in the fourth quarter of this year.
InvestingPro Insights
Amidst the ongoing development of Regulus Therapeutics' treatment for Autosomal Dominant Polycystic Kidney Disease, investors and analysts are closely monitoring the company's financial health and stock performance. According to real-time data from InvestingPro, Regulus Therapeutics holds a market capitalization of $130.28 million, with a notable Price to Book ratio of 1.53 as of the last twelve months leading up to Q1 2024. Despite challenges, the company has demonstrated a strong return over the last month with a 24.26% price total return, and an even more impressive six-month return at 91.6%.
InvestingPro Tips suggest that while Regulus has more cash than debt on its balance sheet, and liquid assets exceeding short-term obligations, the company is quickly burning through cash and suffers from weak gross profit margins. Analysts have revised their earnings upwards for the upcoming period, but they do not anticipate the company will be profitable this year. These financial nuances may shape investor expectations and could be pivotal in assessing the company's ability to sustain its drug development endeavors.
For readers interested in a deeper dive into Regulus Therapeutics' financials and stock performance, there are additional InvestingPro Tips available, which can be accessed through the dedicated page for Regulus at https://www.investing.com/pro/RGLS. To enhance your investment analysis, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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