Regulus Therapeutics(RGLS)- NASDAQ
  • Tue, Aug. 2, 4:39 PM
    • Regulus Therapeutics (NASDAQ:RGLS): Q2 EPS of -$0.40 misses by $0.02.
    • Revenue of $0.5M (-86.9% Y/Y) misses by $1.99M.
    • Press Release
    | Tue, Aug. 2, 4:39 PM
  • Wed, Jul. 27, 6:24 PM
    • Regulus Therapeutics (NASDAQ:RGLS) announces that its has received a letter from the FDA detailing what it needs to do to get its Investigational New Drug (IND) status back on track for lead product candidate RG-101. The agency placed the IND on Clinical Hold last month after investigators reported a second serious adverse event (jaundice).
    • The agency has requested the following: detailed safety data from preclinical and clinical studies, exploration of potential mechanisms of hepatotoxicity in non-clinical models, review and input from independent hepatotoxicity experts, additional pharmacokinetic data fro the U.S. Phase 1 trial and a risk/benefit assessment for the proposed therapeutic regimens containing RG-101.
    • The company expects to submit the information in early Q4. The FDA will respond within 30 days thereafter.
    • Shares are off 1% after hours on light volume.
    • Previously: FDA places Regulus' IND for lead product candidate on clinical hold after second serious adverse event; shares off 50% premarket (June 27)
    | Wed, Jul. 27, 6:24 PM
  • Thu, Jul. 14, 12:46 PM
    | Thu, Jul. 14, 12:46 PM | 12 Comments
  • Fri, Jul. 1, 10:28 AM
    • GlaxoSmithKline (NYSE:GSK) upgraded to Buy from Neutral by Citigroup. Price target is 1800p (14% upside).
    • Alexion Pharmaceuticals (NASDAQ:ALXN) upgraded to Buy from Neutral by Citigroup. Price target is $154 (29% upside).
    • IPG Photonics (NASDAQ:IPGP) upgraded to Buy from Hold by Canaccord Genuity. Price target raised to $90 (13% upside) from $85.
    • Centene (NYSE:CNC) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $86 (21% upside) from $84.
    • Pacira Pharmaceuticals (NASDAQ:PCRX) downgraded to Hold from Buy by Brean Capital.
    • TESARO (NASDAQ:TSRO) downgraded to Hold from Buy by Jefferies.
    • Esperion Therapeutics (NASDAQ:ESPR) downgraded to Equal Weight from Overweight with a $13 (26% upside) price target (from $28) by Barclays. Downgraded to Neutral from Overweight with a $15 (46% upside) price target (from $50) by JPMorgan. Downgraded to Underperform from Neutral with a $10 (0% upside) price target (from $23) by Credit Suisse.
    • HeartWare International (NASDAQ:HTWR) downgraded to Market Perform from Outperform by Wells Fargo. Downgraded to Neutral from Buy with a $58 (0% upside) price target (from $60) by SunTrust Robinson Humphrey.
    • Regulus Therapeutics (NASDAQ:RGLS) downgraded to Market Perform from Outperform by BMO Capital. Price target lowered to $4 (30% upside) from $16.
    • HealthSouth (NYSE:HLS) downgraded to Underweight from Equal Weight by Barclays. Price target lowered to $42 (8% upside) from $45.
    • SciQuest (NASDAQ:SQI) downgraded to Market Perform from Outperform by Raymond James.
    • Quest Diagnostics (NYSE:DGX) downgraded to from Neutral to Sell by Jyske Bank.
    | Fri, Jul. 1, 10:28 AM | 5 Comments
  • Tue, Jun. 28, 12:46 PM
    | Tue, Jun. 28, 12:46 PM | 2 Comments
  • Tue, Jun. 28, 11:00 AM
    | Tue, Jun. 28, 11:00 AM
  • Tue, Jun. 28, 9:18 AM
    | Tue, Jun. 28, 9:18 AM | 1 Comment
  • 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
  • Thu, Jun. 23, 4:17 PM
    • Regulus Therapeutics (NASDAQ:RGLS) inks a loan and security agreement wit Oxford Finance LLC for up to $30M in a series of term loans. Yesterday, the company borrowed $20M at 8.51% + 30-day U.S. Dollar LIBOR.
    • The remaining $10M may be borrowed following the achievement of the milestone of positive interim safety and efficacy data from a Phase 2 clinical trial assessing RG-101 and GlaxoSmithKline's (NYSE:GSK) oral GSK 175 for the treatment of hepatitis C virus infection no later than March 31, 2017.
    • All the loans will mature on June 1, 2020 and will be interest-only through June 1, 2018. A final payment of 5.5% of the principal amount will be due when the loans are due or paid off.
    • The funds will be used for working capital and general corporate purposes.
    | Thu, Jun. 23, 4:17 PM
  • Mon, Jun. 20, 10:06 AM
    • Enanta Pharmaceuticals (ENTA +2.5%commences the proof-of-concept portion of its ongoing Phase 1 study evaluating EDP-494, a pan-genotypic cyclophilin inhibitor, in patients with hepatitis C virus (HCV) genotypes 1 or 3 infection. The double-blind, randomized phase will assess the safety, pharmacokinetics and anti-viral activity of two different oral doses of EDP-494 in treatment-naive HCV patients, administered once daily for 14 days.
    • According to the company, there is increasing resistance to currently available direct-acting HCV antivirals (DAAs). EDP-494 avoids this problem via its unique mechanism of action, inhibiting a protein called cyclophilin which plays an essential role in HCV replication. EDP-494 is called a host-targeting antiviral which means that it targets the host proteins that are involved in the viral life cycle. Other HCV therapies are categorized as virus-targeting antivirals since they act directly on viral proteins. It says cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
    • After the Phase 1 is completed, Enanta intends to develop EDP-494, in combination with one or more DAAs, for treatment-resistant HCV infection.
    • HCV-related tickers: (GILD +1.6%)(JNJ +1.1%)(BMY +1%)(MRK +1%)(GSK +3.4%)(RGLS +0.7%)(ABBV +1.7%)
    | Mon, Jun. 20, 10:06 AM | 15 Comments
  • 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
  • Wed, Jun. 1, 8:45 AM
    • Regulus Therapeutics (NASDAQ:RGLS) expands its clinical trial collaboration with GlaxoSmithKline (NYSE:GSK) for the development of RG-101 with a new randomized dose-ranging Phase 2 study assessing the combination of RG-101 and Glaxo's long-acting parenteral formulation of GSK2878175 as a potential single-visit cure for patients with chronic hepatitis C virus (HCV) infection. The trial, to be conducted outside the U.S., should commence in Q4.
    • The companies project the availability of interim data in H2 2017. If all goes well, a pivotal trial could start in late 2017.
    • Earlier this year, an open-label Phase 2 study commenced assessing a single injection of 4 mg/kg of RG-101 and daily oral doses of 20 mg of GSK2878175 for up to 12 weeks in treatment-naive patients infected with HCV genotypes 1 and 3. Interim data are expected in late Q4.
    • 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.
    • GSK2878175 is a non-nucleoside NS5B polymerase inhibitor.
    • Previously: Regulus teams up with Glaxo in mid-stage HCV study (Nov. 3, 2015)
    | Wed, Jun. 1, 8:45 AM | 2 Comments
  • Mon, May 2, 4:20 PM
    • Regulus Therapeutics (NASDAQ:RGLS): Q1 EPS of -$0.40 misses by $0.07.
    • Revenue of $0.5M (-88.1% Y/Y)
    • Press Release
    | Mon, May 2, 4:20 PM
  • 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
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