Tuesday, H.C. Wainwright raised its price target for Regulus (NASDAQ:RGLS) Therapeutics (NASDAQ:RGLS) shares to $10 from the previous $9 while maintaining a Buy rating on the stock. This adjustment follows the announcement of favorable topline results from the latest phase of a clinical study.
On Monday, Regulus Therapeutics unveiled positive topline outcomes from the third cohort of the Phase 1b multiple-ascending dose (MAD) study for its treatment candidate, RGLS8429, in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study included 16 subjects who were assigned in a 3:1 ratio to either receive 3 mg/kg of RGLS8429 or a placebo biweekly for a duration of three months. The findings indicated that RGLS8429 was well tolerated and did not raise any safety concerns.
In light of these results, H.C. Wainwright has increased the probability of RGLS8429's approval from 50% to 55%. The firm's estimated market value now stands at $690 million, which translates to roughly $10 per share. The analyst firm reaffirmed its Buy rating, citing the new data and updated approval likelihood as the basis for the revised 12-month price target.
The successful trial results and subsequent price target increase reflect a positive development for Regulus Therapeutics as it advances its treatment through the clinical pipeline. The company's focus on ADPKD, a genetic disorder characterized by the growth of numerous cysts in the kidneys, represents a significant area of unmet medical need. With this recent progress, Regulus continues to demonstrate its commitment to addressing this challenging condition.
In other recent news, Regulus Therapeutics has announced positive topline results from Phase 1b Cohort 3 studies of RGLS8429, a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study revealed a dose response in urinary biomarkers and a reduction in kidney volume in a majority of patients at the 3 mg/kg dose level. Analysts from Jones Trading reiterated their Buy rating on Regulus, maintaining a price target of $8.00, reflecting confidence in the company's ongoing research.
Further, the company has begun 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. According to Jones Trading, the next significant update from Regulus is expected to be the fixed dose data, available in late 2024 or early 2025.
Regulus Therapeutics' President and Head of Research & Development, Preston Klassen, M.D., and CEO Jay Hagan expressed satisfaction with the consistent response and safety profile observed. Regulus anticipates an End-of-Phase 1 meeting with the FDA in the fourth quarter of this year.
InvestingPro Insights
Following the positive news from Regulus Therapeutics' clinical study and the upgraded price target by H.C. Wainwright, a glimpse into the company's financial health through InvestingPro data reveals a mixed picture. Regulus holds more cash than debt, a point of reassurance for investors concerned about the company's liquidity. However, the company's gross profit margins remain weak, and analysts are not expecting profitability within this fiscal year. The stock has experienced significant volatility, with a large uptick in price over the last six months, yet it has underperformed over the last decade. As of the latest data, Regulus has a market cap of approximately $134.21 million and a Price/Book ratio of 1.25, which could indicate that the stock is reasonably valued in terms of its assets.
Investors looking to make informed decisions can find additional insights and metrics on InvestingPro. For instance, Regulus' stock has seen a high return over the last year despite recent price volatility. With more InvestingPro Tips available, those interested can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking further analysis that could guide investment choices. Currently, there are 11 additional tips listed on InvestingPro to help investors evaluate Regulus Therapeutics' potential more comprehensively.
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