Gilead Sciences, Inc. (GILD) - NASDAQ
  • Today, 10:03 AM
    • Medivation (MDVN +1.3%) has asked for indications of interest by mid-August, CNBC's David Faber says, with a number of pursuers in the mix.
    • Earlier this month, Medivation entered confidentiality agreements with potential suitors, including a hostile bid from Sanofi (SNY -1.5%).
    • Sanofi continues to hold interest in an acquisition, along with Pfizer (PFE +0.2%), Gilead Sciences (GILD -1.1%) and Celgene (CELG -0.4%).
    | Today, 10:03 AM | 7 Comments
  • Mon, Jul. 25, 5:37 PM
    | Mon, Jul. 25, 5:37 PM
  • Mon, Jul. 25, 4:47 PM
    • Gilead Sciences (NASDAQ:GILD) Q2 results ($M): Total Revenues: 7,776 (-5.7%); Product Sales: 7,651 (-5.8%).
    • Net Income: 3,497 (-22.2%); Non-GAAP Net Income: 4,177 (-13.8%); EPS: 2.58 (-11.6%); Non-GAAP EPS: 3.08 (-2.2%).
    • Key Product Sales: Harvoni: 2,564 (-28.9%); Sovaldi: 1,358 (+5.2%); Truvada: 942 (+11.0%); Atripla: 673 (-13.9%); Stribild: 429 (-4.0%); Viread: 287 (+5.9%).
    • 2016 Guidance: Net Product Sales: $29.5B - 30.5B from $30.0B - 31.0B; Non-GAAP Gross Margin: 88-90% (unch); Diluted Impact of Certain Items: $1.47-1.53 from $1.10-1.16.
    • Shares are down 4% after hours on robust volume.
    | Mon, Jul. 25, 4:47 PM | 56 Comments
  • Fri, Jun. 24, 10:25 AM
    • Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
    • Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
    | Fri, Jun. 24, 10:25 AM | 85 Comments
  • Thu, Jun. 16, 11:35 AM
    • Thinly traded nano cap GlobeImmune (GBIM +34%) is up on more than a 9x surge in volume. Shares are up almost 60% since Monday. No particular news accounts for the bullish action although a month ago the company announced that it was seeking strategic transactions to boost shareholder value.
    • Week 48 results from a Phase 2 clinical trial run by licensee Gilead Sciences (GILD -0.2%), GS-US-330-1401, assessing lead product candidate GS-4774 are expected in the coming months. Results at week 24 fell short of expectations.
    • Data from a Phase 2 study evaluating GI-6301 for the treatment of medullary thyroid cancer are expected in H2. Another Phase 2, assessing GI-6301 in a rare type of cancer called chordoma, is still recruiting patients.
    • Previously: GlobeImmune therapeutic vaccine candidate for hepatitis B flunks Phase 2 study; shares off 62% premarket (May 27, 2015)
    | Thu, Jun. 16, 11:35 AM | 3 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
  • Fri, Apr. 29, 9:12 AM
    | Fri, Apr. 29, 9:12 AM | 9 Comments
  • Thu, Apr. 28, 4:21 PM
    • Gilead Sciences (NASDAQ:GILD) Q1 results ($M): Total Revenues: 7,794 (+2.6%); Product Sales: 7,681 (+3.7%). Consensus view: 8,100. 
    • Net Income: 3,566 (-17.7%); Non-GAAP Net Income: 4,274 (-7.2%); EPS: 2.53 (-8.3%); Non-GAAP EPS: 3.03 (+3.1%). Consensus view: 3.14. 
    • Key Product Sales: Harvoni: 3,017 (-15.7%); Sovaldi: 1,277 (+31.4%); Truvada: 898 (+16.5%); Atripla: 489 (-1.0%); Stribild: 477 (+34.0%); Complera/Eviplera: 381 (+19.1%); Viread: 272 (+16.2%).
    • 2016 Guidance: Net Product Sales: $30B - 31B (unch); diluted impact of certain items: $1.10 - 1.16 (unch); Non-GAAP Gross Margin: 88 - 90% (unch).
    • Shares are down 6% after hours on robust volume.
    | Thu, Apr. 28, 4:21 PM | 71 Comments
  • 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 | 32 Comments
  • Wed, Apr. 6, 1:45 PM
    | Wed, Apr. 6, 1:45 PM | 19 Comments
  • Tue, Mar. 29, 1:02 PM
    • Thinly traded nano cap ContraVir Pharmaceuticals (CTRV +20.1%) is up on a whopping 61x surge in volume in response to its announcement of results from a third-party laboratory (in vitro) study that showed greater antiviral activity in a hepatitis B virus (HBV) cell culture for product candidate CMX157 compared to Gilead Sciences' (GILD -0.9%) tenofovir alafenamide fumarate (TAF).
    • The study evaluated the anti-hepatitis B activities of CMX157 and other tenofovir prodrugs, including Gilead's Viread (tenofovir disoproxil fumarate), in order to profile CMX157. The ability of each to shut down HBV replication was determined by a parameter called effective concentration (EC), which measures the degree to which viral replication is inhibited for a given concentration of drug. EC50, for example, is the concentration of drug that reduces viral replication by 50%. EC50 values for CMX157 and TAF were 9.3 (range: 5.7 - 12.9) and 32.4 (range: 15.3 - 49.5), respectively. A lower value implies that the drug is more potent, although not necessarily more efficacious. EC90 (HBV viral replication inhibited 90%) values were 186 (range: 133 - 239) and 474 (range: 213 - 735), respectively. No values for Viread are provided.
    • ContraVir recently initiated a Phase 1/2a study assessing CMX157. The 2a portion, expected to commence in Q2, will compare it against Viread.
    • Tenofovir is a compound called a lipid acyclic nucleoside phosphonate. It is an effective antiviral agent but is limited by low oral bioavailability, renal toxicity and poor cell penetration.  According to the company, CMX157's novel formulation enables it to deliver high intracellular concentrations of tenofovir thereby making it more effective at permanently suppressing HBV replication than existing drugs.
    • Gilead is currently transitioning its TDF (tenofovir disoproxil fumarate) products to TAF because its has equivalent efficacy at one tenth the dose and is easier on the bones and kidneys. The FDA cleared TAF for HIV-1 on March 1. Its marketing applications for hep B are currently under review in the U.S. and Europe.
    • Previously: ContraVir Pharma adds to up move, shares rise 22% (March 22)
    | Tue, Mar. 29, 1:02 PM | 25 Comments
  • Tue, Mar. 22, 5:37 PM
    • Merck (NYSE:MRK) is up 0.9% after a quick 3.7% spike after hours, and Gilead Sciences (NASDAQ:GILD) down 2.1%, as a jury has decided that Merck's 2002 patents related to sofosbuvir are valid, lending credence to Merck's argument that Gilead is infringing via its Pharmasset unit, acquired in 2011.
    • Gilead's Sovaldi and Harvoni were ruled last month to infringe on Merck patents, and the next step was to decide the validity of the Merck patents.
    • The case now proceeds to damages owed. Sovaldi and Harvoni brought $19.2B in global sales last year.
    • Merck has demanded more than $2B in damages and 10% of Gilead's sales of the products going forward.
    • Previously: Merck after a big slice of Gilead's sofosbuvir pie (Mar. 08 2016)
    | Tue, Mar. 22, 5:37 PM | 123 Comments
  • Tue, Mar. 22, 1:21 PM
    • Thinly traded nano cap ContraVir Pharmaceuticals (CTRV +21.6%) is up again today on a 6x surge in volume. Shares have jumped over 42% since the company announced the initiation of a Phase 1/2a clinical trial assessing CMX157 for the treatment of hepatitis B virus (HBV) infection.
    • The Phase 1 portion will evaluate ascending doses of CMX157 in 50 healthy volunteers for safety, tolerability and pharmacokinetics.
    • Phase 2a will enroll 60 treatment-naive patients with chronic HBV infection and will compare CMX157 to Gilead Sciences' (GILD +1%) Viread (tenofovir disoproxil fumarate)(TDF). It will also consist of a sequential dose escalation with 10 participants per cohort receiving four weeks of once-daily 5, 10, 25, 50 or 100 mg of CMX157 and two participants who will receive 300 mg of CMX157 daily, the standard dose of Viread.
    • Patient dosing in the Phase 1 should commence in the next several weeks. The Phase 2a will commence in Q2.
    • Tenofovir is a compound called a lipid acyclic nucleoside phosphonate. It is an effective antiviral agent but is limited by low oral bioavailability, renal toxicity and poor cell penetration. According to the company, CMX157's novel formulation enables it to deliver high intracellular concentrations of tenofovir thereby making it more effective at permanently suppressing HBV replication than existing drugs.
    | Tue, Mar. 22, 1:21 PM | 12 Comments
  • Tue, Mar. 8, 9:13 AM
    • Sydney, Australia-based Benitec (NASDAQ:BNTC) announces that its DNA-directed RNA interference (ddRNAi) candidate, BB-HB-331, showed robust and durable hepatitis B virus (HBV) suppression in vivo following a single administration.
    • The HBV suppression activity of BB-HB-331 was assessed in the Phoenix mouse model in which murine liver cells were replaced by human hepatocytes which made them susceptible to HBV infection. Once infected, the mice received a single systemic injection of BB-HB-331. Serum antigen levels, HBV viral proteins and extracellular HBV DNA were measured once per week for the duration of the eight-week study.
    • Results showed a 1.83 log knockdown of serum HBV DNA, equivalent to a 98.5% reduction of circulating HBV. In addition, intracellular HBV DNA was reduced 94.9% while HBV surface antigen (HBsAg) and e antigen (HBeAg) were reduced by 97.6% and 92.6%, respectively. The results validated the previously reported in vitro findings.
    • BB-HB-331 combines the gene silencing of RNA interference with the therapeutic potential of gene therapy. It is comprised of an AAV8 capsid (protein shell of a virus) and recombinant DNA engineered to express three short hairpin RNAs that target and inhibit viral RNA expressed from three regions across multiple HBV genotypes. The company plans to advance BB-HB-331 to clinical development.
    • Previously: Benitec Biopharma's ddRNAi therapeutic candidate shows potent anti-HBV antigen activity in preclinical testing; shares up 14% (Dec. 7, 2015)
    • HBV-related tickers: (NASDAQ:GILD)(OTCQB:COCP)(NYSE:GSK)(NASDAQ:IONS)(NASDAQ:DVAX)(NYSE:JNJ)(NASDAQ:ARWR)(NYSE:MRK)(NASDAQ:CTRV)(NASDAQ:ABUS)(NYSE:SNY)(NASDAQ:ALNY)(NYSE:BMY)
    • Update: Shares up 26% in early trading.
    | Tue, Mar. 8, 9:13 AM | 8 Comments
  • 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, 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 | 65 Comments
Company Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Its primary areas of focus include primary areas of focus include human immunodeficiency virus (HIV), liver diseases such as... More
Sector: Healthcare
Industry: Biotechnology
Country: United States