GlaxoSmithKline(GSK)- NYSE
  • Thu, Aug. 11, 1:06 PM
    • Micro cap Nymox Pharmaceutical (NYMX +31.4%) perks up on more than a 12x surge in volume in response to its announcement that it expects to file a marketing application (presumably in the U.S.) within the next two quarters seeking approval of fexapotide for the treatment of men with an enlarged prostate, called benign prostate hyperplasia or BPH. In addition, the company says it does not envision needing more cash for the pre-marketing development of fexapotide (it will need new capital for commercialization, though). It intends to partner with a larger company once fexapotide is approved, provided satisfactory terms can be agreed upon.
    • Fexapotide is administered directly into the prostate via a transrectal injection that does not require anesthesia or sedation. Results from long-term studies (seven years of follow-up) showed a prostate cancer incidence rate of only 1.3% in men treated with fexapotide compared to ~23% in the general population and ~20% in men treated with PDE5 inhibitors for erectile dysfunction [Pfizer's (NYSE:PFE) Viagra, Eli Lilly's (NYSE:LLY) Cialis, Bayer (OTCPK:BAYRY) and GlaxoSmithKline's (NYSE:GSK) Levitra].
    • Previously: Nymox's lead product candidate reduces incidence of prostate cancer in long-term study; shares up 29% (June 22)
    | Thu, Aug. 11, 1:06 PM | 7 Comments
  • Mon, Aug. 1, 9:24 PM
    • Express Scripts (ESRX +0.1%) is adding new drugs to its excluded list, meaning some treatments from makers including Valeant (VRX -6.3%), Eli Lilly (LLY +0.4%), and Bristol-Myers Squibb (BMY +1.8%) won't be covered by insurance.
    • The 2017 list covers 85 excluded drugs, vs. 87 excluded in 2016, the company said.
    • Excluded drugs include Valeant's Zyclara skin cream for actinic keratosis; Bristol's arthritis drug Orencia, Lilly's Taltz psoriasis treatment and some brands of gout drug colchicine.
    • Meanwhile, previously excluded drugs like Pfizer's (PFE +1.1%) Xeljanz and Xeljanz XR arthritis treatments, and GlaxoSmithKline's (GSK +0.4%) Arnuity Ellipta and Floven Diskus asthma treatments, will be covered again.
    • Express Scripts says exclusions have provided for better negotiated prices and savings for customers of an estimated $1.8B in 2017.
    | Mon, Aug. 1, 9:24 PM | 76 Comments
  • Wed, Jul. 27, 7:15 AM
    • GlaxoSmithKline (NYSE:GSK): Q2 EPS of £0.25
    • Revenue of £6.53B (+10.9% Y/Y)
    • Shares +2.11% PM.
    • Press Release
    | Wed, Jul. 27, 7:15 AM | 3 Comments
  • Wed, Jul. 6, 5:39 PM
    • Top gainers, as of 5.25 p.m.: EMKR +10.2%. FMSA +5.1%. EZPW +4.7%. KEM +4.6%. WDC +3.4%.
    • Top losers, as of 5.25p.m.: IBN -10.0%. EXK -4.5%. GSK -3.3%. FRSH -3.0%. MLNX -3.0%.
    | Wed, Jul. 6, 5:39 PM | 1 Comment
  • Tue, Jul. 5, 5:38 PM
    • Top gainers, as of 5.25 p.m.: QUNR +18.1%. GRMN +13.6%. ABBV +4.0%. YY +3.2%. QRVO +2.1%.
    • Top losers, as of 5.25p.m.: IBN -15.8%. NUS -10.3%. GSK -3.3%. CIG -1.7%. KOPN -1.4%.
    | Tue, Jul. 5, 5:38 PM | 4 Comments
  • Thu, Jun. 30, 4:18 PM
    • Array BioPharma (NASDAQ:ARRY) files a New Drug Application (NDA) with the FDA seeking approval of lead product candidate binimetinib for the treatment NRAS mutation-positive melanoma. The principal data supporting the application was generated in the Phase 3 NEMO study which showed an improvement in progression-free survival versus the chemo agent dacarbazine.
    • Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. Array licensed binimetinib to Novartis (NYSE:NVS) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (NYSE:GSK) oncology business in early 2015.
    • Previously: Array Bio's lead product candidate successful in late-stage melanoma study; shares up 28% premarket (Dec. 16, 2015)
    | Thu, Jun. 30, 4:18 PM | 2 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
  • Mon, Jun. 20, 9:16 AM
    | Mon, Jun. 20, 9:16 AM | 1 Comment
  • 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 | 47 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
  • Fri, Apr. 1, 10:00 AM
    • Array BioPharma (ARRY -3.7%) slumps on increased volume in response to its announcement that it has terminated its Phase 3 study, MILO, assessing binimetinib in low-grade ovarian cancer due to lack of efficacy. Detailed results will be shared with the scientific community at a later date.
    • Binimetinib inhibits a protein kinase enzyme called MEK, which plays a key role in a certain cellular signaling pathway that is over-activated in certain cancers, especially those that express the mutations BRAF, KRAS and NRAS. It is being investigated in BRAF-positive (COLUMBUS study) and NRAS-positive (NEMO study) melanoma.
    • Array licensed binimetinib to Novartis (NVS -2.3%) in 2010 but reacquired the rights after Novartis acquired GlaxoSmithKline's (GSK -1.7%) oncology business in early 2015.
    • Now read Earnings Peek: Array BioPharma Has A Lot Going On And A Lot of Money
    | Fri, Apr. 1, 10:00 AM | 1 Comment
  • 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
  • Tue, Feb. 9, 9:02 AM
    • VBI Vaccines (NASDAQ:VBIV) enters into a research collaboration with GlaxoSmithKline (NYSE:GSK) to evaluate VBI's LPV Platform in a defined field.
    • The LPV Platform is a proprietary formulation and process that enables vaccines and biologics to maintain their stability, potency and safety. This is an important issue considering most vaccines and biologics are highly sensitive to temperature and physical stress. Most require storage between 4 and 8 degrees Celsius to preserve their integrity. Being able to store these products at room temperature, for example, would be a significant benefit.
    • Specific financial terms of the partnership are not disclosed.
    • VBIV is up 13% premarket on modest volume.
    | Tue, Feb. 9, 9:02 AM | 1 Comment
  • Mon, Jan. 25, 9:34 AM
    • Thinly traded nano cap XTL Biopharmaceuticals (XTLB) is up 10% out of the blocks this morning in response to its announcement that has received encouraging written guidance from the FDA ahead of its IND filing for lead product candidate, hCDR1, for the treatment of lupus erythematosus (SLE).
    • The agency suggests that the primary efficacy endpoint be based on a measure of lupus disease activity called the BILAG index, which was the secondary endpoint in a prior Phase 2 study of hCDR1. It also recommends the study be run as a Phase 2 and includes guidance regarding the appropriate patient population and the number of subjects needed to prove safety.
    • According to the company, the trial design, based on the FDA's feedback, increases its likelihood of success since it will be substantially the same as the prior Phase 2 study which showed efficacy in the 0.5 mg dose as measured by the BILAG index.
    • SLE, a chronic autoimmune disorder, affects more than 5M people worldwide. There has been only one drug approved by the FDA in the past 50 years to treat the disease [Glaxo's (GSK +0.4%Benlysta (belimumab)]. Two drugs in late-stage development failed to achieve their primary efficacy endpoints, demonstrating the challenging nature of SLE.
    | Mon, Jan. 25, 9:34 AM
  • Dec. 28, 2015, 5:39 PM
    • Top gainers, as of 5.25 p.m.: PBY +6.2%. WSH +3.5%. SDRL +3.2%. RIG +2.4%. RMBS +1.9%.
    • Top losers, as of 5.25p.m.: NOK -3.6%. GSK -1.3%. NWL -1.1%. GSM -0.9%. REXI -0.8%.
    | Dec. 28, 2015, 5:39 PM
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