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Regulus (RGLS) Up 71% on Topline Data from Kidney Disease Study
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Shares of Regulus Therapeutics (RGLS - Free Report) surged 71% on Mar 12 after management announced topline data from the second cohort of the ongoing phase Ib multiple-ascending dose (MAD) study on its lead product candidate RGLS8429 in autosomal dominant polycystic kidney disease (ADPKD).
The second cohort enrolled 14 participants who were randomized in a ratio of 3:1 to receive either 2 mg/kg of RGLS8429 or a placebo every other week for three months.
Data from the study showed strong evidence of the drug's effectiveness of a mechanistic dose response at a 2mg/kg dose based on urinary measurements of polycystins 1 and 2 (PC1 and PC2). The urinary measurements demonstrated greater biological activity of RGLS8429 at 2mg/kg compared to 1mg/kg and placebo. Treatment with the drug was well tolerated in study participants with no safety concerns.
Management also shared exploratory results from three patients with the highest increases in PC1 and PC2. These patients experienced reductions in height-adjusted total kidney volume (htTKV) greater than 4%, along with a decrease in total kidney cyst volume (TKCV).
A leading cause of end-stage renal disease, ADPKD is marked by the development of multiple fluid-filled cysts, primarily in the kidneys and, to a lesser extent, in the liver and other organs. The excessive proliferation of kidney cyst cells ultimately leads to end-stage renal disease. Per management estimates, nearly 160,000 individuals in the United States alone are diagnosed with this disease.
Year to date, shares of Regulus have surged 93.4% against the industry’s 3.7% fall.
Image Source: Zacks Investment Research
Based on the above results, management expanded the sample size of the fourth cohort of the MAD study from 14 to up to 30 patients. This cohort is evaluating a fixed dose of 300mg of RGLS8429 dosed every other week for three months. Screening is expected to start in the second quarter of 2024.
Regulus is currently dosing patients in the third cohort of the MAD study patients with either 3mg/kg of RGLS8429 or a placebo every other week for three months. Enrolment in this cohort has been completed and top-line data from the same is expected in mid-2024.
Management also recently held a Type D meeting with the FDA to discuss the approval for RGLS8429 under the accelerated pathway. The company stated that this meeting was constructive and also confirmed the potential for accelerated approval based on a single mid-stage study on the drug. Regulus intends to design this pivotal mid-stage study after reporting results from third and fourth cohorts of the MAD study.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 37.6%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPShave risen from $4.06 to $4.40. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.01. Year to date, shares of ANIP have risen 20.7%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, estimates for GSK’s 2024 EPS have risen from $3.87 to $4.03. During the same period, EPS estimates for 2025 have improved from $4.20 to $4.39. Year to date, shares of GSK have risen 16.8%.
GSK's earnings beat estimates in three of the trailing four quarters while missing the mark on one occasion. On average, GSK’s four-quarter earnings surprise was 7.59%.
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Regulus (RGLS) Up 71% on Topline Data from Kidney Disease Study
Shares of Regulus Therapeutics (RGLS - Free Report) surged 71% on Mar 12 after management announced topline data from the second cohort of the ongoing phase Ib multiple-ascending dose (MAD) study on its lead product candidate RGLS8429 in autosomal dominant polycystic kidney disease (ADPKD).
The second cohort enrolled 14 participants who were randomized in a ratio of 3:1 to receive either 2 mg/kg of RGLS8429 or a placebo every other week for three months.
Data from the study showed strong evidence of the drug's effectiveness of a mechanistic dose response at a 2mg/kg dose based on urinary measurements of polycystins 1 and 2 (PC1 and PC2). The urinary measurements demonstrated greater biological activity of RGLS8429 at 2mg/kg compared to 1mg/kg and placebo. Treatment with the drug was well tolerated in study participants with no safety concerns.
Management also shared exploratory results from three patients with the highest increases in PC1 and PC2. These patients experienced reductions in height-adjusted total kidney volume (htTKV) greater than 4%, along with a decrease in total kidney cyst volume (TKCV).
A leading cause of end-stage renal disease, ADPKD is marked by the development of multiple fluid-filled cysts, primarily in the kidneys and, to a lesser extent, in the liver and other organs. The excessive proliferation of kidney cyst cells ultimately leads to end-stage renal disease. Per management estimates, nearly 160,000 individuals in the United States alone are diagnosed with this disease.
Year to date, shares of Regulus have surged 93.4% against the industry’s 3.7% fall.
Image Source: Zacks Investment Research
Based on the above results, management expanded the sample size of the fourth cohort of the MAD study from 14 to up to 30 patients. This cohort is evaluating a fixed dose of 300mg of RGLS8429 dosed every other week for three months. Screening is expected to start in the second quarter of 2024.
Regulus is currently dosing patients in the third cohort of the MAD study patients with either 3mg/kg of RGLS8429 or a placebo every other week for three months. Enrolment in this cohort has been completed and top-line data from the same is expected in mid-2024.
Management also recently held a Type D meeting with the FDA to discuss the approval for RGLS8429 under the accelerated pathway. The company stated that this meeting was constructive and also confirmed the potential for accelerated approval based on a single mid-stage study on the drug. Regulus intends to design this pivotal mid-stage study after reporting results from third and fourth cohorts of the MAD study.
Regulus Therapeutics Inc. Price
Regulus Therapeutics Inc. price | Regulus Therapeutics Inc. Quote
Zacks Rank & Key Picks
Regulus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and GSK plc (GSK - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 37.6%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPShave risen from $4.06 to $4.40. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.01. Year to date, shares of ANIP have risen 20.7%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, estimates for GSK’s 2024 EPS have risen from $3.87 to $4.03. During the same period, EPS estimates for 2025 have improved from $4.20 to $4.39. Year to date, shares of GSK have risen 16.8%.
GSK's earnings beat estimates in three of the trailing four quarters while missing the mark on one occasion. On average, GSK’s four-quarter earnings surprise was 7.59%.