GlaxoSmithKline (GSK) - NYSE
  • Wed, Jun. 15, 9:14 AM
    • Results from a Phase 3 clinical trial, HBV-23, evaluating Dynavax's (NASDAQ:DVAX) hepatitis B vaccine candidate, HEPLISAV-B ([Hepatitis B Vaccine, Recombinant (Adjuvanted)] showed a higher rate of seroprotection compared to GlaxoSmithKline's (NYSE:GSK) ENGERIX-B [Hepatitis B Vaccine (Recombinant)]. The results were presented at the 76th Annual Scientific Sessions of the American Diabetes Association in New Orleans, LA.
    • The randomized, observer-blinded, active-controlled study enrolled over 8,000 participants, including 1,144 adults with type 2 diabetes (diabetics are especially vulnerable to hepatitis B virus (HBV) infection).
    • Diabetic patients receiving HEPLISAV-B showed a 90.0% seroprotection rate versus 65.1% for ENGERIX-B, a statistically significant difference of 24.9%. In patients aged 60 - 70, the seroprotection rate also favored HEPLISAV-B, 85.8% versus 58.5%, as did obese (body mass index >= 30) patients, 89.5% compared to 61.4%.
    • The rates of adverse events were similar between the two groups.
    • HEPLISAV-B's additional value proposition is a two-dose regimen (initial and one month) compared to ENGERIX-B's three-doses (initial, one month, six months).
    • The FDA's action date (PDUFA) for its review of Dynavax's Biologics License Application (BLA) is December 15.
    | Wed, Jun. 15, 9:14 AM | 22 Comments
  • Wed, Jun. 8, 8:23 AM
    • A 1,670-subject Phase 3 clinical trial, SIRROUND-D, evaluating sirukumab in adult patients with moderately to severely active rheumatoid arthritis (RA) met both co-primary endpoints. The data will be presented at the Annual European Congress of Rheumatology on June 11 in London.
    • Results showed patients treated with sirukumab experienced significantly less joint destruction than placebo (p<0.001) from baseline to week 52 as measured by a method called Sharp van der Heijde Score which is used to measure joint damage observed in X-ray images. The sirukumab group was also superior to placebo in the proportion of patients achieving ACR20 (20% improvement in RA symptoms) at week 16 (p<0.001).
    • All major secondary endpoints were also met. Regulatory applications are on tap for Q3.
    • Sirukumab is being co-developed by GlaxoSmithKline (NYSE:GSK) and Janssen Biologics (NYSE:JNJ) in a partnership that began in late 2011. It is a human monoclonal IgG kappa antibody that binds to interleukin-6 (IL-6), a cytokine that plays a key role in autoimmune conditions. The companies expect it to be a blockbuster generating peak sales of $1B+.
    | Wed, Jun. 8, 8:23 AM | 2 Comments
  • Thu, Jun. 2, 8:21 AM
    • Buoyed by discussions with the FDA, GlaxoSmithKline (NYSE:GSK) plans to file its New Drug Application (NDA) seeking approval of its triple combination therapy for the treatment of chronic obstructive pulmonary disease (COPD) by the end of 2016 instead of H1 2018, as previously expected.
    • The company's candidate, a combination of fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI), employs three different mechanisms of action to help open the airways of COPD patients, a more effective approach compared to current doublet therapies.
    • Glaxo aims to maintain its lead in respiratory medicine, especially against AstraZeneca (NYSE:AZN) and Novartis (NYSE:NVS) who are developing their own "closed triple" combination products.
    | Thu, Jun. 2, 8:21 AM
  • 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
  • Fri, May 27, 4:24 PM
    • The European Commission approves Strimvelis, an ex-vivo stem cell gene therapy for the treatment of an ultra-rare inherited disorder called Severe Combined Immunodeficiency due to Adenosine Deaminase deficiency (ADA-SCID). Children born with the homozygous disease do not have a fully functioning immune system and are unable to fight off common infections. It affects ~15 European children each year.
    • Strimvelis is only administered once and does not rely on a third party donor. The patient's own bone marrow cells are removed and a vector is used to insert a normal copy of the ADA gene into the cells, which are then reintroduced into the patient via IV infusion. In order to improve the engraftment of the gene-modified cells into the bone marrow, patients are pretreated with low-dose chemo.
    • The data supporting the application was collected from 18 children with ADA-SCID. All participants in the pivotal study (n=12) who received Strimvelis were alive three years post treatment. All the children (n=18) who contributed to the data package are alive today (median follow up of ~seven years). The complete data analysis was recently published in the journal BLOOD.
    • Strimvelis, developed by GlaxoSmithKline (GSK -0.8%) and Italian firms Fondazioine Telethon and Ospedale San Raffaele, is first corrective gene therapy for children to gain regulatory clearance anywhere in the world. It is the second gene therapy approved in the EU, following uniQure's (NASDAQ:QURE) Glybera (alipogene tiparvovec), approved in November 2012 for the treatment of lipoprotein lipase deficiency.
    | Fri, May 27, 4:24 PM
  • Thu, May 26, 7:53 AM
    • Ionis Pharmaceuticals (NASDAQ:IONS) reports that strategic alliance partner GlaxoSmithKline (NYSE:GSK) has elected not to proceed with a Phase 3 clinical trial, CARDIO-TTR, assessing antisense drug IONIS-TTRrx in patients with transthyretin (TTR) amyloid cardiomyopathy. The trial was placed on clinical hold by the FDA last month due to safety issues identified in Ionis' Phase 3 study, NEURO-TTR, evaluating IONIS-TTRrx in TTR familial amyloid polyneuropathy (FAP). Glaxo says it will evaluate its options once more data are available from ongoing studies.
    • TTR amyloidosis is a rare inherited condition caused by the abnormal formation and aggregation of TTR amyloid deposits in various tissues and organs. It is slowly progressive and fatal. The exact incidence is unknown but is thought to affect one in 100K people. FAP is characterized by the accumulation of misfolded mutated TTR protein in the peripheral nerves. TTR-related cardiomyopathy is characterized by the accumulation of misfolded TTR protein in cardiac muscle.
    • Ionis will host a conference call this morning at 9:00 am ET to update investors on its IONIS-TTRrx program.
    • IONS is down 7% premarket on light volume.
    • Previously: Glaxo's late-stage study of Ionis Pharma's IONIS-TTRrx on clinical hold; Ionis shares down 11% (April 7)
    • Update: According to a report by JP Morgan, the safety issue is abnormal drops in platelet counts, observed in no more than five patients.
    | Thu, May 26, 7:53 AM | 46 Comments
  • Tue, May 24, 8:22 AM
    • Results from the post-approval Salford Lung Study showed the superiority of GlaxoSmithKline's (NYSE:GSK) Relvar Ellipta 100/25 mcg (fluticasone furoate/vilanterol or FF/VI), marketed as Breo Ellipta in the U.S., to usual care in reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Usual care included long-acting muscarinic antagonists (LAMA), long-acting beta2-agonists (LABA) and inhaled corticosteroids (ICS) administered as monotherapy, dual or triple combinations.
    • Patients treated with FF/VI showed a statistically valid reduction of 8.4% in the rate of moderate or severe exacerbations versus usual care (p=0.025). The incidence of serious adverse events (SAEs) was similar: 29% for FF/VI and 27% for usual care. For pneumonia, an SAE of special interest, the rates were also similar: 7% for FF/VI and 6% for usual care.
    • The intent of the Phase 3b Salford Lung Study was to assess FF/VI in a "real world" practice setting instead of the highly controlled setting of a pivotal clinical trial. It enrolled 2802 COPD patients across a broad demographic. Average age was 67 years and gender was almost equal with males comprising 51% of the total.
    • Relvar Ellipta was approved in Europe in November 2013 and in Japan September 2013. The FDA approved Breo Ellipta in May 2013.
    | Tue, May 24, 8:22 AM | 1 Comment
  • Tue, May 24, 7:05 AM
    • The FDA approves Holly Springs, NC-based Seqirus' FLUCELVAX QUADRIVALENT, the firs four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people at least four year old. The vaccine helps protect individuals against two influenza A and two B viruses for the current flu season.
    • The traditional flu vaccine is trivalent, consisting of two influenza A viruses and one influenza B strain, although Sanofi's (NYSE:SNY) quadrivalent flu vaccine was approved by the FDA in December 2014 for use in adults.
    • Each year, about 200K Americans are hospitalized due to flu complications.
    • Seqirus was created in July 2015 when bioCSL and Novartis' (NYSE:NVS) influenza vaccines business combined, creating the second largest influenza vaccine company in the world. Novartis sold the business to Australian blood products firm CSL Ltd. in October 2014 for $275M.
    | Tue, May 24, 7:05 AM
  • Fri, May 6, 10:32 AM
    • Baxter International (BAX -1.1%) initiated with Buy rating and $51 (13% upside) price target by Evercore ISI.
    • Intrexon (XON +2.3%) initiated with Market Outperform rating and $42 (62% upside) price target by JMP Securities.
    • Heron Therapeutics (HRTX -8.8%) initiated with Buy rating and $41 (143% upside) price target by Cantor Fitzgerald.
    • Dr. Reddy's Laboratories (RDY -2.5%) initiated with Neutral rating and Rs.3,334 price target (8% upside) by Goldman Sachs.
    • Aeglea BioTherapeutics (AGLE +7.4%) initiated with Buy rating and $12 (33% upside) price target by UBS.
    • Cardiome (CRME +34.9%) upgraded to Speculative Buy from Hold by Mackie Research. Price target raised to $8.60 (58% upside) from $5.20.
    • Medivation (MDVN +1.2%) upgraded to Buy from Neutral by Citigroup. Price target raised to $73 (22% upside) from $37.
    • Masimo (MASI -0.3%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $52 (13% upside) from $43.
    • GlaxoSmithKline (GSK -1%) upgraded to Buy from Reduce by Oddo & Cie.
    • Cogentix Medical (CGNT -1%) downgraded to Neutral from Buy with a price target of $1.15 (14% upside) by Roth Capital.
    • Bruker (BRKR +0.8%) downgraded to Neutral from Outperform by BTIG Research.
    • Relypsa (RLYP -4%) downgraded to Underperform from Neutral by Mizuho Securities. Price target cut to $31 (132% upside) from $34.
    • Molina Healthcare (MOH -0.7%) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $45 (0% upside) from $75. Downgraded to Neutral from Buy by UBS. Price target lowered to $54 (20% upside) from $76.
    • Sarepta Therapeutics (SRPT +1.8%) downgraded to Underperform from Market Perform by Leerink Swann. Price target lowered to $5 (71% downside risk) from $13.
    • Sanofi (SNY -0.4%) downgraded to Hold from Buy with an €81 (15% upside) price target by HSBC.
    | Fri, May 6, 10:32 AM | 4 Comments
  • Thu, May 5, 11:26 AM
    • GlaxoSmithKline (GSK -0.2%) Chairman Philip Hampton says management is not considering breaking up the pharmaceuticals group and spinning off consumer health, a move backed by certain institutional shareholders. Instead, the firm will focus on improving the performance of the consumer unit.
    • The company continues to be pressured to ramp up (or streamline) its business. In Q1, sales grew 11% but earnings were down 96%. The consumer business accounted for over 28% of revenues.
    • Glaxo is in the market for a new CEO. In March, current chief Andrew Witty announced his intention to retire in March 2017.
    | Thu, May 5, 11:26 AM | 5 Comments
  • Wed, Apr. 27, 11:13 AM
    • Privately held Sunovion Pharmaceuticals announces successful results from two Phase 3 clinical trials, GOLDEN-3 and GOLDEN-4, assessing an inhalable mist formulation of SUN-101 (glycopyrrolate) in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). Both studies (25 mcg and 50 mcg doses) met their primary endpoints of a statistically valid change from baseline to week 12 versus placebo in trough forced expiratory volume in one second (FEV1). Full results will be presented at future medical conferences.
    • SUN-101 is a nebulized (mist) long-acting muscarinic antagonist (LAMA) delivered via an inhalation device called eFlow, developed by the German firm PARI.
    • The company intends to file a New Drug Application (NDA) with the FDA this year. According to the company, SUN-101/eFlow, if approved, will be the first nebulized LAMA available for COPD patients, but AstraZeneca (AZN -0.9%) just received FDA approval of its LAMA/LABA offering, Bevespi Aerosphere.
    • Related tickers: (GSK +1.7%)(MYL -1.5%)(NVS -0.2%)(TEVA -0.2%)(THRX)(AQXP -3.3%)
    • Previously: AstraZeneca up 1.6% as FDA approves COPD treatment (April 25)
    | Wed, Apr. 27, 11:13 AM | 1 Comment
  • Wed, Apr. 27, 7:54 AM
    • GlaxoSmithKline (NYSE:GSK) Q1 results (₤M): Total Revenues: 6,229 (+10.8%); Pharmaceuticals: 3,586 (+1.8%); ViiV Healthcare: 729; Consumer Healthcare: 1,761 (+27.3%).
    • Total Innovative Pharmaceuticals: 2,247 (-7.4%); Respiratory: 1,418 (+0.7%); Established Products: 610 (-6.2%).
    • EPS: 5.8p (-96.5%); CF Ops: 503 (+35.9%).
    • 2016 Guidance: Core EPS growth: 10 - 12%.
    • Shares are up 3% premarket on increased volume.
    | Wed, Apr. 27, 7:54 AM | 7 Comments
  • Wed, Apr. 27, 7:18 AM
    • GlaxoSmithKline (NYSE:GSK): Q1 EPS of £0.20
    • Revenue of £6.23B (+10.9% Y/Y)
    • Press Release
    | Wed, Apr. 27, 7:18 AM
  • Mon, Apr. 11, 4:25 PM
    • Nabriva Therapeutics AG (NBRV -2.2%) initiates its second Phase 3 clinical trial, LEAP 2, assessing lead product candidate QIDP-tagged lefamulin for the treatment of community-acquired bacterial pneumonia (CABP). The 740-subject randomized, double-blind, placebo-controlled, non-inferiority study will compare the efficacy of oral lefamulin to oral moxifloxacin [Bayer's (OTCPK:BAYRY) Avelox] in patients with moderate CABP. Patients will be randomized (1:1) to receive either 600 mg of lefamulin twice daily for seven days or 400 mg of moxifloxacin once daily for seven days.
    • The first Phase 3, LEAP 1, is assessing the intravenous formulation of lefamulin but allows participants to switch to oral therapy. Top-line results from both studies should be available in H2 2017.
    • Lefamulin is a new class of antibiotic called a pleuromutilin. If all goes well, it will be the first such antibiotic approved for systemic use in humans. A topical formulation of a pleuromutilin, GlaxoSmithKline's (NYSE:GSK) Altabax (retapamulin), was approved by the FDA in April 2007.
    | Mon, Apr. 11, 4:25 PM | 2 Comments
  • Mon, Apr. 11, 8:24 AM
    • Can-Fite BioPharma (NYSEMKT:CANF) announces that its candidate for the treatment of erectile dysfunction (ED), CF602, showed statistically significant full recovery one hour after a single 500 u/kg dose in a preclinical diabetic rat model.
    • According to the company, CF602's novel mechanism of action may provide a treatment benefit to patients who do not respond adequately to PDE5 inhibitors [Pfizer's (NYSE:PFE) Viagra (sildenafil citrate), Eli Lilly's (NYSE:LLY) Cialis (tadalafil), Bayer (OTCPK:BAYRY) and GlaxoSmithKline's (NYSE:GSK) Levitra (vardenafil HCl)].
    • Last October, the company announced the results from a preclinical study that showed CF602 restored the impaired vascular endothelial growth factor system in the penises of diabetic rats which induced an increase in nitric oxide which resulted in improved penile erection compared to placebo. Its unique mechanism of action is apparently similar to Viagra. 
    • The company intends to file an Investigational New Drug (IND) with the FDA in Q4.
    • Shares are up 7% premarket on increased volume.
    • Previously: Can-Fite's CF602 shows Viagra-like action in diabetic rats; shares up 10% premarket (Oct. 22, 2015)
    | Mon, Apr. 11, 8:24 AM | 2 Comments
  • Thu, Apr. 7, 10:22 AM
    • Ionis Pharmaceuticals (IONS -10.8%) slumps on average volume in apparent response to its announcement that the FDA has placed GlaxoSmithKline's (GSK -0.6%) Phase 3 clinical trial assessing IONIS-TTRrx in patients with transthyretin (TTR) amyloid cardiomyopathy on clinical hold while GSK provides answers to the agency's questions about the protocol stemming from Ionis' ongoing Phase 3 study evaluating IONIS-TTRrx in patients with TTR familial amyloid polyneuropathy (FAP). The FDA's action is standard operating procedure if there are questions about a study protocol so it is not necessarily a negative event.
    • TTR amyloidosis is a rare inherited condition caused by the abnormal formation and aggregation of TTR amyloid deposits in various tissues and organs. It is slowly progressive and fatal. The exact incidence is unknown but is thought to affect one in 100K people. FAP is characterized by the accumulation of misfolded mutated TTR protein in the peripheral nerves. TTR-related cardiomyopathy is characterized by the accumulation of misfolded TTR protein in cardiac muscle.
    • IONIS-TTRrx is an antisense drug that targets a specific sequence of RNA. It is designed to reduce the production of TTR. It is administered once per week via injection. It has Orphan Drug and Fast Track status in the U.S. for FAP and Orphan Drug status in the EU for the broader indication of TTR amyloidosis. Glaxo and Ionis are co-developing the product candidate under their March 2010 strategic alliance.
    | Thu, Apr. 7, 10:22 AM | 11 Comments
Company Description
GlaxoSmithKline Plc operates as a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. It operates in three primary areas of business: Pharmaceuticals, Vaccines and Consumer Healthcare. The Pharmaceuticals business researches,... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: United Kingdom