Regulus’ (RGLS - Free Report) shares were up almost 35% on Apr 13, after it announced the completion of patient enrollment in the first cohort of the RGLS8429 study.
The early-stage clinical study evaluating RGLS8429 is a double-blind, placebo-controlled study assessing the drug’s safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in adult patients with autosomal dominant polycystic kidney disease (ADPKD).
The study will evaluate the safety and PK/PD of RGLS8429 treatment across three different dose levels, including measuring changes in polycystins, height-adjusted total kidney volume and overall kidney function.
ADPKD is a leading cause of end-stage renal disease, affecting approximately 160,000 individuals in the United States. The condition is characterized 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.
Regulus' shares have plunged 52% in the past year compared with the industry's 15.2% decline.
Preclinical models have shown that the administration of RGLS8429 has demonstrated clear improvements in kidney function, size and other measures of disease severity.
The first cohort is being dosed at 1 mg/kg of RGLS8429 or placebo every other week for three months. The cohort’s top-line data are expected to be available around the end of the third quarter of 2023.
Regulus expects to begin dosing the second cohort after reviewing all available cohort 1 safety data, which is planned for May 2023.
Zacks Rank & Stocks to Consider
Currently, Regulus has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are CRISPR Therapeutics (CRSP - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Allogene Therapeutics (ALLO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP's shares have plunged 18.7% in the past year
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 58.2% in the past year.
The company’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO’s earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company’s shares have plunged 38.8% in the past year.
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Regulus’ (RGLS - Free Report) shares were up almost 35% on Apr 13, after it announced the completion of patient enrollment in the first cohort of the RGLS8429 study.
The early-stage clinical study evaluating RGLS8429 is a double-blind, placebo-controlled study assessing the drug’s safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in adult patients with autosomal dominant polycystic kidney disease (ADPKD).
The study will evaluate the safety and PK/PD of RGLS8429 treatment across three different dose levels, including measuring changes in polycystins, height-adjusted total kidney volume and overall kidney function.
ADPKD is a leading cause of end-stage renal disease, affecting approximately 160,000 individuals in the United States. The condition is characterized 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.
Regulus' shares have plunged 52% in the past year compared with the industry's 15.2% decline.
Preclinical models have shown that the administration of RGLS8429 has demonstrated clear improvements in kidney function, size and other measures of disease severity.
The first cohort is being dosed at 1 mg/kg of RGLS8429 or placebo every other week for three months. The cohort’s top-line data are expected to be available around the end of the third quarter of 2023.
Regulus expects to begin dosing the second cohort after reviewing all available cohort 1 safety data, which is planned for May 2023.
Zacks Rank & Stocks to Consider
Currently, Regulus has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are CRISPR Therapeutics (CRSP - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Allogene Therapeutics (ALLO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.
CRISPR Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP's shares have plunged 18.7% in the past year
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 58.2% in the past year.
The company’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO’s earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company’s shares have plunged 38.8% in the past year.
Free Report – The Bitcoin Profit Phenomenon
Zacks Investment Research has released a Special Report to help you pursue massive profits from the world’s first and largest decentralized form of money.
No guarantees for the future, but in the past three presidential election years, Bitcoin’s returns were as follows: 2012 +272.4%, 2016 +161.1%, and 2020 +302.8%.
Zacks predicts another significant surge. Click below for Bitcoin: A Tumultuous Yet Resilient History.
Download Now – Today It’s FREE >>
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