REGULUS THERAPEUTICS INC.

(RGLS)
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Delayed Nasdaq  -  04:00 2022-08-18 pm EDT
1.730 USD   +0.58%
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Regulus Therapeutics Announces Receipt of FDA Orphan Drug Designation for RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease

06/21/2022 | 08:00am EDT

Regulus Therapeutics Inc. announced that the U.S. Food and Drug Administration has granted orphan drug designation to RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan designation status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval. About ADPKD Autosomal Dominant Polycystic Kidney Disease (ADPKD), caused by mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease 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. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60. Approximately 160,000 individuals are diagnosed with the disease in the United States alone, with an estimated global prevalence of 4 to 7 million. RGLS8429 is a novel, next generation oligonucleotide for the treatment of ADPKD designed to inhibit miR-17 and to preferentially target the kidney. Administration of RGLS8429 has shown robust data in preclinical models, where clear improvements in kidney function, size, and other measures of disease severity have been demonstrated along with a superior pharmacologic profile in preclinical studies compared to Regulus' first-generation compound. Regulus is currently conducting a Phase 1 single-ascending dose study in healthy volunteers to assess safety, tolerability, and pharmacokinetics of RGLS8429.


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08/11REGULUS : Q2 Earnings Snapshot
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08/11TRANSCRIPT : Regulus Therapeutics Inc., Q2 2022 Earnings Call, Aug 11, 2022
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Financials (USD)
Sales 2022 - - -
Net income 2022 -28,1 M - -
Net Debt 2022 - - -
P/E ratio 2022 -0,27x
Yield 2022 -
Capitalization 25,3 M 25,3 M -
Capi. / Sales 2022 -
Capi. / Sales 2023 12,2x
Nbr of Employees 26
Free-Float 86,4%
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Number of Analysts 3
Last Close Price 1,73 $
Average target price 20,00 $
Spread / Average Target 1 056%
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Managers and Directors
Joseph P. Hagan President, Chief Executive Officer & Director
Crispina Calsada Chief Financial Officer
Stelios Papadopoulos Chairman
Denis Drygin Chief Scientific Officer
David Baltimore Independent Director
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