Regulus Therapeutics (RGLS) - NASDAQ
  • Yesterday, 12:46 PM
    | Yesterday, 12:46 PM | 1 Comment
  • Yesterday, 11:00 AM
    | Yesterday, 11:00 AM
  • Yesterday, 9:18 AM
    | Yesterday, 9:18 AM
  • Mon, Jun. 27, 5:35 PM
    | Mon, Jun. 27, 5:35 PM | 3 Comments
  • Mon, Jun. 27, 4:36 PM
    • The FDA has verbally notified Regulus Therapeutics (NASDAQ:RGLS) that its approved Investigational New Drug (IND) application for lead product candidate RG-101 for the treatment of hepatitis C virus (HCV) infection has been placed on clinical hold (prohibiting the recruitment of new patients to clinical studies) after the company reported a second serious adverse event (SAE) of jaundice. The SAE occurred in an HCV patient with end-stage renal disease on dialysis in its ongoing U.S.-based Phase 1 trial 117 days after receiving a single dose of RG-101. Regulus expects to receive a clinical hold letter within the next 30 days. It intends to work closely with agency to promptly investigate and resolve the issue.
    • The timelines for Regulus' three ongoing studies of RG-101 will not be impacted since all are fully enrolled and all participants have completed dosing. Top-line data will be presented at upcoming scientific conferences.
    • Management will host a conference call today at 5:00 pm ET to discuss the situation.
    • RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
    • Shares are down a fraction after hours.
    • Update: shares are down 50% premarket.
    | Mon, Jun. 27, 4:36 PM | 1 Comment
  • Tue, Jun. 7, 10:43 AM
    • Micro cap Regulus Therapeutics (RGLS -4.9%) slumps on average volume after its announcement of Phase 2 data on lead product candidate RG-101 for the treatment of hepatitis C virus (HCV) infection failed to excite investors.
    • The ongoing mid-stage study is assessing a four-week once-daily treatment regimen of RG-101, in combination with Gilead Sciences' (GILD +0.5%) Harvoni (ledipasvir/sofosbuvir) or Janssen's (JNJ +0.1%) Olysio (simeprevir) or Bristol-Myers Squibb's (BMY +0.4%) Daklinza (daclatasvir) in 79 treatment-naive patients with HCV genotypes 1 and 4 infection.
    • Cure rates, defined as sustained virologic response 12 weeks following the end of treatment (SVR12), were 100% for the combination with Harvoni, 96.3% for the combination with Olysio and 91.7% for the combination with Daklinza.
    • 24 weeks after the end of therapy, however, the cure rates dropped to 80.0% and 88.9%, respectively, for Olysio and Daklinza but remained at 100% for Harvoni, clouding the picture for RG-101's efficacy.
    • RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
    | Tue, Jun. 7, 10:43 AM | 21 Comments
  • Fri, Apr. 15, 12:41 PM
    | Fri, Apr. 15, 12:41 PM
  • Fri, Apr. 15, 9:13 AM
    | Fri, Apr. 15, 9:13 AM | 1 Comment
  • Fri, Apr. 15, 9:03 AM
    • Regulus Therapeutics (NASDAQ:RGLS) is up 11% premarket on higher-than-normal volume in response to its announcement of additional interim results from its ongoing Phase 2 development of RG-101 for the treatment of chronic hepatitis C virus (HCV) infection. The data were presented at The International Liver Congress 2016 in Barcelona, Spain.
    • The study was designed to assess a shortened four-week regimen of RG-101, 2 mg/kg administered via subcutaneous injection at day 1 and day 29, in combination with four weeks of a once/daily antiviral: Gilead Sciences' (NASDAQ:GILD) Harvoni (ledipasvir/sofosbuvir), J&J's (NYSE:JNJ) Olysio (simeprevir) or Bristol-Myers Squibb's (NYSE:BMY) Daklinza (daclatasvir). 79 treatment-naive HCV-1 and HCV-4 patients were enrolled in three arms: Harvoni: n=27; Olysio: n=27; Daklinza: n-25.
    • Cure rates at week 8 for RG-101 + Harvoni, RG-101 + Olysio and RG-101 + Daklinza were 100%, 100% and 90.9%, respectively. Cure rates at week 12 were 100%, 93.3%, and 100%, respectively (one relapse in Olysio arm).
    • RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
    • Previously: Regulus Therapeutics' HCV candidate shows 97% cure rate after eight weeks in mid-stage study; shares up 43% premarket (Feb. 17)
    • Read now Regulus Add-On Could Help Regulate Hep C Drug Costs 
    | Fri, Apr. 15, 9:03 AM | 31 Comments
  • Wed, Apr. 6, 1:45 PM
    | Wed, Apr. 6, 1:45 PM | 19 Comments
  • Mon, Feb. 22, 5:45 PM
    • Top gainers, as of 5.25 p.m.: LNTH +22.5%. RGLS +5.1%. ROG +4.8%. MDR +4.3%. TXRH +4.2%.
    • Top losers, as of 5.25p.m.: CHGG -20.4%. FIT -15.7%. GFI -8.0%. VRX -7.5%. COG -5.3%.
    | Mon, Feb. 22, 5:45 PM
  • Wed, Feb. 17, 3:59 PM
    • It's rare, but Gilead Sciences (GILD -2%) failed to participate in biotech's up day. The reason for the lack of buying appears to be the earlier news of positive Phase 2 data from Regulus Therapeutics (RGLS +18.5%) regarding HCV candidate RG-101. Preliminary results showed a 97% cure rate from a four-week regimen of RG-101 and certain retrovirals, including Harvoni. It seems like a long shot, but investors apparently perceive a risk that the regimen will gain traction and Harvoni sales could (theoretically) be cut in half.
    • Previously: Regulus Therapeutics' HCV candidate shows 97% cure rate after eight weeks in mid-stage study; shares up 43% premarket (Feb. 17)
    | Wed, Feb. 17, 3:59 PM | 222 Comments
  • Wed, Feb. 17, 9:14 AM
    | Wed, Feb. 17, 9:14 AM | 6 Comments
  • Wed, Feb. 17, 8:55 AM
    • Micro cap Regulus Therapeutics (NASDAQ:RGLS) is up 43% premarket on robust volume in response to its announcement of positive interim results from a Phase 2 clinical trial assessing RG-101, in combination with other antivirals, in patients with chronic hepatitis C virus (HCV) infection.
    • The study was designed to evaluate a four-week treatment regimen of 2 mg/kg of RG-101 at Day 1 and Day 29, in addition to four weeks of once/daily Harvoni (ledipasvir/sofosbuvir), Olysio (simeprevir) or Daklinza (daclatasvir). Seventy-nine HCV-1 and HCV-4 patients are enrolled, while 38 have been evaluated through eight weeks of follow up. Of these, 97% (n=37/38) had HCV RNA viral loads below the limit of quantification (SVR12). For those assessed through 12 weeks of follow up, 100% (n=14/14) remained below the level of detection.
    • The primary endpoint analysis (12 week follow up) for all 79 subjects should be available in late Q2.
    • RG-101 is a microRNA therapeutic, specifically a GalNAc-conjugated anti-microRNA targeting microRNA-122. MicroRNAs are small bits of RNA, typically 20 - 25 nucleotides long, that do not encode proteins but regulate gene expression. Researchers believe as many as two-thirds of human genes are regulated by microRNAs.
    • Related tickers: (NASDAQ:GILD)(NYSE:JNJ)(NYSE:BMY)(NYSE:ABBV)(NYSE:MRK)
    | Wed, Feb. 17, 8:55 AM | 64 Comments
  • Nov. 4, 2015, 12:44 PM
    | Nov. 4, 2015, 12:44 PM | 1 Comment
  • Nov. 3, 2015, 8:55 AM
    • Regulus Therapeutics (NASDAQ:RGLS) is up 5% premarket on light volume in response to its announcement of a clinical trial collaboration and formulation development agreement with GlaxoSmithKline (NYSE:GSK) related to Regulus' investigational microRNA therapeutic RG-101 and Glaxo's investigational non-nucleoside NS5B polymerase inhibitor, GSK2878175, for the treatment of HCV infection.
    • The companies intend to initiate a Phase 2 clinical trial in Q1 (outside of the U.S.) that will assess a single subcutaneous dose of 4 mg/kg of RG-101 in combination with a daily oral dose of 20 mg of GSK2878175 for up to 12 weeks in treatment-naive patients with chronic HCV genotypes 1 and 3 infection.
    • Concurrent with the trial, Glaxo will work on a long-acting parenteral for injection (LAP) formulation of GSK2878175 that could be a good administrative fit with RG-101.
    • Neither company has further obligations or commitments beyond the Phase 2 study.
    | Nov. 3, 2015, 8:55 AM
Company Description
Regulus Therapeutics, Inc. engages in the discovery and development of drugs target microRNAs to treat a broad range of diseases. It is developing RG-101, which targets miR-122, a host factor for the hepatitis C virus infection. The company was founded in September 2007 and is headquartered in... More
Sector: Healthcare
Industry: Drug Related Products
Country: United States