Last $6.52 USD
Change Today -0.23 / -3.41%
Volume 39.4K
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As of 8:10 PM 07/25/14 All times are local (Market data is delayed by at least 15 minutes).

regulus therapeutics inc (RGLS) Snapshot

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02/25/14 - $11.88
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regulus therapeutics inc (RGLS) Details

Regulus Therapeutics Inc., a biopharmaceutical company, focuses on the discovery and development of drugs that target microRNAs for the treatment of various diseases in the United States. The company uses its microRNA product platform to develop anti-miRs, which is chemically modified and single-stranded oligonucleotide. Its clinical candidate products include RG-101, which is a GalNAc-conjugated anti-miR that targets microRNA-122 for the treatment of patients with chronic hepatitis C virus infection. The company has strategic collaboration with Biogen Idec MA Inc. for the evaluation of the use of microRNA signatures as a biomarker for human patients with multiple sclerosis; AstraZeneca AB to discover and develop microRNA therapeutics for cardiovascular diseases, metabolic diseases, and oncology; and GlaxoSmithKline plc to discover and develop microRNA therapeutics for immuno-inflammatory diseases. It also has strategic collaboration with Sanofi for the discovery and development of microRNA therapeutics comprising miR-21 pre-clinical fibrosis program for the treatment of alport syndrome and preclinical program for oncology indications; and preclinical programs targeting miR-221/222 for oncology indications. Regulus Therapeutics Inc. was founded in 2007 and is headquartered in San Diego, California.

74 Employees
Last Reported Date: 05/9/14
Founded in 2007

regulus therapeutics inc (RGLS) Top Compensated Officers

Chief Executive Officer, President, Principal...
Total Annual Compensation: $600.0K
Chief Scientific Officer
Total Annual Compensation: $350.0K
Compensation as of Fiscal Year 2013.

regulus therapeutics inc (RGLS) Key Developments

Regulus Therapeutics Inc. Receives Orphan Drug Designation for RG-012

Regulus Therapeutics Inc. announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, as a therapeutic for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. According to the FDA, the Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected the costs of developing and marketing a treatment drug. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies. Alport syndrome is a life-threatening genetic kidney disease that impacts the body's ability to create a specific type of collagen highly expressed in the kidney and essential to normal kidney structure. In the absence of this type of collagen, the kidneys are unable to effectively filter toxins and waste products, resulting in end-stage renal disease and also hearing loss or effects on vision. Currently, there is no approved therapy for Alport syndrome. Regulus has discovered that miR-21 is highly overexpressed in mouse models of Alport syndrome. Regulus is developing RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of miR-21, which has demonstrated potent inhibition of miR-21 in vitro and in vivo, a decrease in the rate of progression of renal fibrosis, an increase in the lifespan of mice by up to 50%, and a favorable pharmacokinetic profile that supports the potential for a once per week dosing regimen. In the near term, Regulus expects to initiate a natural history of disease study to gather greater information about the progression of Alport syndrome and expects to initiate a Phase I clinical study of RG-012 for the treatment of Alport syndrome in the first half of 2015.

Regulus Appoints Paul C. Grint, M.D. as Chief Medical Officer

Regulus Therapeutics Inc. announced the appointment of Paul C. Grint, M.D. to its executive management team as Chief Medical Officer. In his new role, Dr. Grint will be responsible for leading and expanding Regulus' microRNA clinical portfolio and will serve as a key member of its executive leadership team. Grint joined Regulus from Cerexa Inc. where he served as President and was responsible for the oversight of anti-infective product development.

Regulus Therapeutics Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2014

Regulus Therapeutics Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2014. For the quarter, the company reported revenues under strategic alliances and collaborations of $1,631,000 against $3,238,000 a year ago. Loss from operations was $10,705,000 against $5,550,000 a year ago. Loss before income taxes was $12,740,000 against $7,239,000 a year ago. Net loss was $12,741,000 or $0.30 per basic and diluted share against $7,229,000 or $0.20 per basic and diluted share a year ago.


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