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Wed, Jul. 1, 11:30 AM
- Galectin Therapeutics (GALT -0.7%) announces the screening of the first five patients in its Phase 2 study, called NASH-CX, evaluating GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). The randomized, placebo-controlled study will enroll 156 patients who will receive either one of two doses of GR-MD-02 (2 mg/kg or 8 mg/kg) or placebo. Final data collection is expected in October 2017. The study completion date is February 2018.
- The primary endpoint is the reduction in hepatic portal vein pressure versus placebo as measured by the hepatic venous pressure gradient (HVPG).
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The FDA designated it for Fast Track review for the treatment of NASH in August 2013.
- NASH is one of the "next big things" for drug makers. It affects as many as 5% of Americans.
- Related tickers: (TBRA +1.7%)(ICPT -1%)(DRRX +0.4%)(MNOV +1.9%)(GLMD)(RGLS -6.3%)(AZN +1.2%)(OTCPK:GNFTF)(CNAT +4.3%)(VBLT +0.2%)(RPTP +2.7%)(LJPC +10.4%)(MRK +1.3%)(SHPG +1.4%)(OTCQB:ISLT)(GILD -0.4%)
Tue, Jun. 2, 9:21 AM
Tue, Jun. 2, 9:04 AM
- Regulus Therapeutics' (NASDAQ:RGLS) President & CEO Kleanthis G. Xanthopoulos, Ph.D., resigned yesterday to pursue investment opportunities in biotech. Chief Medical Officer Paul Grint, M.D., replaces him.
- Chief Scientific Officer Neil W. Gibson, Ph.D., will apparently leave after June 30. Until then he will help Dr. Grint assemble a new management team.
- Shares are down 9% premarket on light volume.
Thu, May 7, 4:37 PM
Mon, Apr. 27, 12:45 PM
Wed, Apr. 8, 9:12 AM
Tue, Apr. 7, 7:51 PM
- Small cap Regulus Therapeutics (NASDAQ:RGLS) jumps 11% after hours on robust volume in response to its announcement that AstraZeneca (NYSE:AZN) will proceed with the clinical development of RG-125 for the treatment of nonalcoholic steatohepatitis (NASH) in type 2 diabetics. This is the first product candidate to be advanced through clinical trials under the companies' 2012 strategic alliance. Under the terms of the agreement, AstraZeneca's will assume responsibility for the development of RG-125 as well as pay Regulus a $2.5M milestone fee. A Phase 1 trial should commence by year-end. Both firms will submit preclinical data on the RG-125 program to be presented at a future scientific meeting.
- RA-125 is a GalNAc (N-Acetylgalactosamine) -conjugated anti-miR targeting microRNA-103/107 (miR-103/107). MicroRNAs are small non-coding RNAs that regulate gene expression. miR-103/107 plays a key role in insulin sensitivity. Inhibiting miR-103/107 leads to a sustained reduction in fasting glucose and fasting insulin levels and decreases liver triglycerides and steatosis.
- GalNAc-conjugation is the most effective way to deliver a subcutaneous dose of an RNA-based therapeutic.
- Previously: Regulus Therapeutics enters into a strategic alliance with AstraZeneca (AZN) to discover,... (Aug. 14, 2012)
Tue, Apr. 7, 5:36 PM
Wed, Mar. 25, 10:47 AM
- The European Commission (EC) designates Regulus Therapeutics' (RGLS -2.4%) microRNA, RG-012, an Orphan Medicinal Product for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.
- RG-012 targets miR-21, a non-coding RNA that that negatively regulates gene/networks and has been reported to be upregulated in fibrotic kidney diseases. Treatment with an anti-miR-21 significantly slows the progression of chronic kidney disease.
- The company is currently enrolling patients in a natural history of disease study, called ATHENA, to gather information about the changes in renal function over time in Alport sufferers. The data will provide the clinical basis for the design of a Phase 2 trial to evaluate the effect of RG-012 on the decline in renal function and time to end-stage renal disease in Alport syndrome patients.
- The FDA tagged RG-012 an Orphan Drug for the treatment of Alport syndrome in July 2014. RG-012 will have a seven-year period of market exclusivity in the U.S., if approved by the FDA and a ten-year period of market exclusivity in the E.U., if approved by the EC.
Thu, Mar. 12, 3:49 PM
- The FDA accepts for review Bristol-Myers Squibb's (BMY +1.6%) resubmitted New Drug Application (NDA) for daclatasvir in combination with Gilead's (GILD +0.8%) sofosbuvir (Sovaldi) for the treatment of chronic hepatitis C (HCV) genotype 3. BMY amended the original NDA to include data from the Phase 3 ALLY-3 study which showed high cure rates for the regimen, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naive and 86% of treatment-experienced HCV-3 patients. The FDA will review the submission within a six-month time frame.
- HCV-3 is the second most common HCV genotype after HCV-1, affecting over 54M people worldwide compared to over 83M for HCV-1. HCV-3 is generally more aggressive and carries a higher risk of hepatocellular carcinoma (liver cancer).
- Daclatasvir is an nonstructural protein 5A (NS5A) replication complex inhibitor. The precise mechanism of action is unknown, but it is suspected that it deregulates the relationship between NS5A and intracellular HCV replication sites.
- Related tickers: (ABBV +2.4%)(MRK +0.1%)(ACHN +0.8%)(RGLS -3%)
Thu, Feb. 19, 10:50 AM
- Regulus Therapeutics (RGLS +0.4%) Q4 results: Revenues: $4.2M (-23.6%); Operating Expense: $13.8M (+36.6%); Operating Loss: ($9.5M) (-102.1%); Net Loss: ($22.2M) (-999%); Loss Per Share: ($0.47) (-327.3%).
- FY2014 results: Revenues: $7.7M (-60.7%); Operating Expense: $52.6M (+40.6%); Operating Loss: ($44.9M) (-152.2%); Net Loss: ($56.7M) (-203.2%); Loss Per Share: ($1.29) (-163.3%); Quick Assets: $159.7M (+40.1%).
- 2015 Guidance: Quick Assets: >$100M.
Wed, Feb. 18, 4:14 PM
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