Regulus Therapeutics

Regulus Announces Key Goals Under its ‘Clinical Map Initiative’ for 2015

Accelerates RG-101 for HCV with Dual-Track Clinical Development Strategy; Top-Line, Single Dose, 4 mg/kg Results as Well as 2mg/kg

Extended Follow Up Results from Ongoing Study to be Reported in Early February 2015

Regulus Therapeutics LogoLA JOLLA, Calif., Jan. 8, 2015 /PRNewswire/ – Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced key goals for 2015 under its ‘Clinical Map Initiative’ to advance its microRNA therapeutics portfolio and biomarkers platform.

“Regulus enters 2015 with the scientific and financial strength to realize the transformative potential of microRNAs.  As such, we’ve set aggressive goals for the year focused on creating a clear path to value for what we believe to be our greatest opportunities,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus.  “Under our ‘Clinical Map Initiative’, we are focusing our near term efforts on accelerating RG-101 for HCV with a Phase II dual-track clinical development strategy, while advancing our overall therapeutics pipeline and aligning our biomarker efforts to streamline our clinical development decisions.”

Key Goals Under Regulus’ ‘Clinical Map Initiative’ for 2015

  • ‘Clinical Map’ of RG-101 for HCV Defined: Dual-Track Strategy Accelerates Phase II Development; Multiple Data Read-Outs in 2015.  Following the favorable interim results reported inOctober 2014 from its ongoing clinical study, Regulus has accelerated development of RG-101, a wholly-owned, GalNAc-conjugated anti-miR targeting microRNA-122 (“miR-122″) for the treatment of HCV.  Regulus is pursuing a Phase II dual-track development strategy (i) to investigate RG-101 in combination with oral agents to potentially shorten treatment durations, optimize clinical outcomes and potentially improve responses in certain underserved HCV patient populations; and (ii) to investigate RG-101 further as a single agent to determine [click to continue…]

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Regulatory Application for RG-101 to be Filed in the Near Term: Clinical Studies in Man Expected to Commence in Early 2014

regulus therapeutics logoLA JOLLA, Calif., Nov. 4, 2013 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that data demonstrating the positive preclinical profile of RG-101 will be presented in a late-breaking poster session at the 64th Annual Meeting of the American Association for the Study of Liver Disease (AASLD) being held in Washington, D.C. on Monday, November 4, 2013 from8:00 a.m. Eastern Standard Time (EST) to 5:30 p.m. EST. The poster is available on the Company’s website at http://www.regulusrx.com.

“RG-101 utilizes a unique mechanism of action by targeting microRNA-122, a liver-specific host factor for stability, replication and translation of HCV.  We believe that therapies that target host-encoded factors essential for HCV replication may act as attractive combination agents because they may demonstrate activity across [click to continue…]

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- Nominated RG-101 in HCV as First microRNA Candidate for Clinical Development-

- Maintained Strong Financial Position with Over $90 million in Cash-

regulus therapeutics logoLA JOLLA, Calif., May 14, 2013 /PRNewswire/ – Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today provided an update on its microRNA therapeutic pipeline under the company’s ‘Road to the Clinic’ strategy and reported financial results for the quarter ended March 31, 2013.

Regulus Continues to Execute on ‘Road to the Clinic’ Strategy:
Nominated RG-101 as First microRNA Candidate for Clinical Development

  • Regulus announced today that it has nominated its first microRNA candidate for clinical development, RG-101, a GalNAc-conjugated microRNA antagonist or anti-miR, which targets microRNA-122 (miR-122) for the treatment of patients with chronic hepatitis C virus (HCV) infection. Regulus is performing additional pre-clinical studies and finalizing development plans for RG-101 in HCV and expects to submit an application with regulatory authorities in early 2014.
  • Regulus plans to develop RG-101 independently of its strategic alliance with GlaxoSmithKline (GSK).  The broad strategic alliance between Regulus and GSK remains intact and GSK retains its interest in the miR-122 program in HCV, as miR-122 will remain a Collaboration Target under the alliance.   As such, the companies are in the process of amending the Product Development and Commercialization Agreement to clarify that RG-101 is fully owned by Regulus.

“The nomination of RG-101 as our first microRNA candidate for clinical development marks a tremendous milestone for Regulus and represents significant achievement of our initial goals under our ‘Road to the Clinic’ strategy,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. “We continue to focus [click to continue…]

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regulus therapeutics logoLA JOLLA, Calif., Nov. 5, 2012 /PRNewswire/ – Regulus Therapeutics Inc. ( NASDAQ : RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, summarized today its recent financing activity that the company expects will enable Regulus to execute its current strategic objectives for the foreseeable future.

In connection with Regulus’ Initial Public Offering (IPO), which closed on October 10, 2012, and other recent financial transactions, Regulus has raised $80.9 million in gross proceeds, including:

  • $50.9 million from the sale of common stock in the IPO, inclusive of an over-allotment option exercise by the underwriters and insider participation by Isis Pharmaceuticals, Inc., one of our founding companies, and two of our strategic partners, Sanofi and GSK;
  • $25.0 million from the sale of common stock in a private placement to AstraZeneca AB, one of [click to continue…]

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Regulus Therapeutics logoLA JOLLA, Calif., Oct. 4, 2012 /PRNewswire/ – Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today the pricing of its initial public offering of 11,250,000 shares of its common stock at $4.00 per share.  Regulus has also granted the underwriters a 30-day option to purchase up to an additional 1,687,500 shares at the initial public offering price to cover overallotments, if any.  Regulus’ common stock is scheduled to begin trading on The NASDAQ Global Market on October 4, 2012 under the symbol “RGLS.”

Lazard Capital Markets LLC, Cowen and Company, LLC and BMO Capital Markets are [click to continue…]

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MicroRNAs as Biomarkers for Multiple Sclerosis – Biogen Idec and Regulus Therapeutics Form Collaboration

August 15, 2012

Biogen Idec and Regulus Therapeutics Form Collaboration to Explore microRNA Biomarkers for Disease Monitoring and Response to Therapy LA JOLLA, Calif., Aug. 15, 2012 /PRNewswire/ — Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has entered into a collaboration with Biogen Idec (NASDAQ: […]

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Regulus Therapeutics Forms Strategic Alliance for Discovery, Development and Commercialization of microRNA Therapeutics with AstraZeneca

August 14, 2012

Focused on three exclusive microRNA targets LA JOLLA, Calif., Aug. 14, 2012 /PRNewswire/ — Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that it has entered into a strategic alliance with AstraZeneca to discover, develop, and commercialize microRNA therapeutics for three exclusive targets which are […]

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Regulus Announces New Publication Showing Potential Therapeutic Benefit of Targeting microRNA-21 in Fibrosis

February 16, 2012

-New study published in Science Translational Medicine demonstrates microRNA-21 contributes to fibrogenesis in the kidney -Regulus, in partnership with Sanofi, developing novel anti-fibrotic therapies targeting microRNAs B.N. Chau et al. “MicroRNA-21 Promotes Fibrosis of the Kidney by Silencing Metabolic Pathways” Sci Transl Med 15 February 2012: Vol. 4, Issue 121, p. 121ra18 Sci. Transl. Med. […]

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Regulus Therapeutics Initiates an Orphan and Rare Disease microRNA Therapeutic Effort in Brain Cancer

December 12, 2011

-Regulus, Accelerate Brain Cancer Cure (ABC2) and Samsung Medical Center to Advance microRNA Therapeutics for Glioblastoma – LA JOLLA, Calif., Dec. 12, 2011 /PRNewswire/ – Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced the initiation of a new discovery effort in microRNA therapeutics for the treatment […]

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Regulus Therapeutics to Present New In Vivo Data for microRNA-21 in Kidney Fibrosis

November 8, 2011

-Regulus Scientists to Provide Update on Lead Therapeutic Program at American Society of Nephrology Meeting- LA JOLLA, Calif., Nov. 8, 2011 /PRNewswire/ — Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced presentations on its preclinical programs for the treatment of fibrosis at the American Association […]

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