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Regulus Therapeutics Inc. - RGLS STOCK NEWS

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Regulus Therapeutics Inc. (NASDAQ: RGLS) is a pioneering biopharmaceutical company dedicated to discovering and developing novel medicines that target microRNAs. With a strong foundation in oligonucleotide drug discovery and development, Regulus has established a comprehensive pipeline of microRNA-based therapeutics and an advanced biomarkers platform known as MicroMarkersSM. The company’s intellectual property estate further solidifies its leadership in the microRNA field.

Regulus is at the forefront of developing innovative treatments for critical health issues. One of its significant projects includes RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 aimed at treating chronic hepatitis C virus infection. Another promising drug candidate is RG-012, which targets microRNA-21 for treating Alport Syndrome, a severe kidney disease driven by genetic mutations with no approved therapies currently available.

Moreover, Regulus, in collaboration with AstraZeneca, is working on RG-125, an anti-miR targeting microRNA-103/107 for treating non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes/pre-diabetes, which has already entered Phase I clinical development. Additionally, RGLS8429, an anti-miR next-generation oligonucleotide targeting miR-17, is in Phase 1b clinical development for treating autosomal dominant polycystic kidney disease (ADPKD).

Recently, Regulus reported positive topline data from the first and second cohorts of the Phase 1b MAD study of RGLS8429. The company has completed enrollment for the third cohort of this study, with topline data expected in mid-2024. The latest updates indicate the initiation of the fourth cohort in May 2024, focusing on a fixed dose of 300 mg of RGLS8429, which will provide further insights into its efficacy and safety.

Financially, Regulus is in a stable position, having recently raised $100 million through a private placement to institutional investors, extending its cash runway until the first half of 2026. For the quarter ended March 31, 2024, the company reported $107.7 million in cash and investments.

Regulus is committed to advancing its pipeline and bringing life-changing therapeutics to patients, with a particular focus on orphan kidney diseases. The company’s strategic collaborations and solid financial base are instrumental in driving its innovative research and development initiatives.

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Regulus Therapeutics Inc. announced the advancement to cohort 4 of the Phase 1b Clinical Trial of RGLS8429 for the treatment of ADPKD. The study will evaluate the safety, efficacy, and impact on total kidney volume in patients with this disease. Positive data from previous cohorts has paved the way for this advancement, with potential for a pivotal Phase 2 trial. The trial aims to assess changes in urinary polycystins, kidney volume, cyst architecture, and overall kidney function.

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Regulus Therapeutics Inc. will participate in the Canaccord Genuity Genetic Medicine for Generalists Webcast Series, with CEO Jay Hagan and President Preston Klassen, M.D. The event, hosted by Whitney Ijem on May 1, 2024, at 1:00 p.m. ET, will be live and available for replay on the company's investor relations website for 90 days.

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Regulus Therapeutics Inc. (RGLS) announces positive topline data from the Phase 1b MAD Clinical Trial of RGLS8429 for ADPKD, along with an oversubscribed $100 million private placement. The company completed the third cohort enrollment and anticipates data in mid-2024. A Type D Meeting with the FDA discussed an accelerated approval pathway for RGLS8429.
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Regulus Therapeutics Inc. (RGLS) has entered into a definitive securities purchase agreement for a private placement with institutional and accredited investors. The oversubscribed financing includes participation from various investors, indicating strong market interest.
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Regulus Therapeutics Inc. announces positive topline results from Phase 1b MAD study of RGLS8429 for ADPKD treatment. Mechanistic dose response observed at 2mg/kg dose level. Cohort 3 fully enrolled with data readout in mid-2024. Company plans to increase sample size for cohort 4. FDA meeting confirms potential for accelerated approval pathway.
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Regulus Therapeutics Inc. (Nasdaq: RGLS) completes enrollment in the third cohort of patients in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD. The company expects topline data from the second cohort in Q1 2024, topline data from the third cohort in mid-2024, and the initiation of the fourth cohort in 2024.
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Regulus Therapeutics Inc. (RGLS) announced CEO Jay Hagan's participation in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on November 29, 2023, at 10:25 a.m. ET. The live presentation replay will be available on the company's investor relations website for 90 days.
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RGLS - Regulus Therapeutics Announces Positive Topline Data from Phase 1b Clinical Trial for RGLS8429 in ADPKD Treatment
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Regulus Therapeutics Inc. (Nasdaq: RGLS) has announced the dosing of the first patient in the third cohort of the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. The Phase 1b MAD study is a double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RGLS8429 in adult patients with ADPKD. The study will evaluate RGLS8429 treatment across three different dose levels and measure changes in polycystins, height-adjusted total kidney volume, cyst architecture, and overall kidney function. The second cohort is being dosed at 2 mg/kg of RGLS8429 or placebo every other week for three months. No issues were identified in cohort two, allowing advancement to cohort three. The third cohort will receive 3 mg/kg of RGLS8429 or placebo every other week for three months.
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Regulus Therapeutics announces advancement to third cohort in Phase 1b MAD study of RGSL8429 for ADPKD treatment
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FAQ

What is the current stock price of Regulus Therapeutics (RGLS)?

The current stock price of Regulus Therapeutics (RGLS) is $1.43 as of November 15, 2024.

What is the market cap of Regulus Therapeutics (RGLS)?

The market cap of Regulus Therapeutics (RGLS) is approximately 93.0M.

What is Regulus Therapeutics Inc. known for?

Regulus Therapeutics Inc. is renowned for its pioneering work in developing innovative medicines targeting microRNAs, aiming to treat various critical diseases including chronic hepatitis C, Alport Syndrome, and ADPKD.

What are the main projects of Regulus Therapeutics?

Regulus is developing RG-101 for chronic hepatitis C, RG-012 for Alport Syndrome, RG-125 for NASH in collaboration with AstraZeneca, and RGLS8429 for ADPKD.

What is RG-101 used for?

RG-101 is a GalNAc-conjugated anti-miR aiming to treat chronic hepatitis C virus infection.

What stage is the clinical development of RGLS8429?

RGLS8429 is in Phase 1b clinical development for treating autosomal dominant polycystic kidney disease (ADPKD), with multiple cohorts already underway.

Who are Regulus Therapeutics' strategic partners?

One significant strategic partner of Regulus Therapeutics is AstraZeneca, collaborating on the development of RG-125 for NASH in patients with type 2 diabetes/pre-diabetes.

What is the financial status of Regulus Therapeutics?

As of March 31, 2024, Regulus Therapeutics had $107.7 million in cash and investments. The company recently raised $100 million through a private placement, extending its cash runway to the first half of 2026.

What recent achievements has Regulus Therapeutics reported?

Recent achievements include positive topline data from the Phase 1b MAD study of RGLS8429, completion of enrollment for the third cohort, and the initiation of the fourth cohort in May 2024.

Where is Regulus Therapeutics headquartered?

Regulus Therapeutics is headquartered in San Diego, California.

What is the focus of Regulus Therapeutics' RGLS8429 program?

The focus of the RGLS8429 program is to develop a next-generation oligonucleotide targeting miR-17 to treat autosomal dominant polycystic kidney disease (ADPKD).

How does Regulus Therapeutics intend to use the funds raised in the private placement?

The funds raised are intended to extend Regulus' cash runway into the first half of 2026, supporting ongoing research and development programs, including the clinical advancement of RGLS8429.

Regulus Therapeutics Inc.

Nasdaq:RGLS

RGLS Rankings

RGLS Stock Data

92.96M
65.50M
1.69%
96.3%
3.82%
Biotechnology
Pharmaceutical Preparations
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United States of America
SAN DIEGO