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GSK

GlaxoSmithKline

$38.10

0.06 (0.16%)

08:01
11/25/16
11/25
08:01
11/25/16
08:01

GlaxoSmithKline starts Phase 3 program investigating daprodustat

GlaxoSmithKline announced the start of a phase III development program investigating daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, as a treatment for anaemia associated with chronic kidney disease. The phase III programme includes two studies evaluating the safety and efficacy of daprodustat compared to recombinant human erythropoietin: ASCEND-D will enrol approximately 3,000 dialysis dependent subjects with anaemia associated with CKD switching from an erythropoietin-stimulating agent. ASCEND-ND will enrol approximately 4,500 non-dialysis dependent subjects with anaemia associated with CKD, and will include patients either switching from or naive to an ESA. For both studies, the co-primary endpoints are time to first occurrence of major adverse cardiovascular events and mean change in haemoglobin between the baseline and efficacy period (mean over Weeks 28-52). The studies will assess whether daprodustat is non-inferior to recombinant human erythropoietin on these endpoints as the primary analysis. If non-inferiority of the primary analysis is met, superiority will be assessed for the safety endpoint. The design of the phase III program is based upon data from phase II clinical trials that were designed to characterise the dose-response relationship between daprodustat and haemoglobin at 4 weeks and assess the safety and tolerability of daprodustat following once-daily administration up to 24 weeks. Data from the 24-week phase II studies were presented at the American Society of Nephrology Kidney Week congress in Chicago, Illinois, earlier in November.

  • 29

    Nov

GSK GlaxoSmithKline
$38.10

0.06 (0.16%)

09/23/16
09/23/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Morgan Stanley analyst Brian Nowak initiated Activision Blizzard (ATVI) and Electronic Arts (EA), both with Overweight ratings. The analyst is bullish on the digital gaming shift away from "units sold" to a business model based on users, engagement, and digital monetization. He sees digital in-game offerings resulting in recurring and growth user bases, increased per-game engagement, and further monetization opportunities. 2. AstraZeneca (AZN) and GlaxoSmithKline (GSK) both initiated with Overweight ratings by Piper Jaffray analyst Richard Purkiss. 3. Achillion (ACHN) initiated with an Outperform by Wedbush analyst Heather Behanna, who set a $13 price target on the shares. 4. Sysco (SYY) initiated with an Underweight at Barclays and $48 price target by analyst Karen Short. 5. Five Below (FIVE), Dollar Tree (DLTR) and Dollar General (DG) all initiated with Equal Weight ratings by Barclays analyst Karen Short. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/03/16
RBCM
10/03/16
NO CHANGE
Target $95
RBCM
Outperform
Gilead HIV franchise could see risk from competitor data, says RBC Capital
RBC Capital analyst Michael Yee said his conversations with doctors leads him to think two dolutegravir HIV "doublet" studies being conducted by GlaxoSmithKline (GSK) and ViiV Healthcare - Glaxo's joint venture with Pfizer (PFE) and Shionogi - are likely to work and present an underappreciated risk to Gilead's (GILD) HIV franchise. Talks with investors lead Yee to believe few are even aware of this risk and that the consensus view is underestimating the probability these non-inferiority trials will work. Arguing that the consensus view should factor in more conservative assumptions for Gilead's HIV business post 2018 due to this risk, Yee cut his price target on Gilead to $95 from $105, but keeps an Outperform rating on the shares.
10/06/16
PIPR
10/06/16
NO CHANGE
Target $46
PIPR
Overweight
Piper thinks Alnylam failure is positive for Ionis
Piper Jaffay analyst Joshua Schimmer thinks Alnylam Pharmaceuticals' (ALNY) "abrupt halt" of revusiran for TTR cardiomyopathy is likely a positive for Ionis Pharmaceuticals' (IONS) transthyretin program. The move "knocks out a competitive drug" while Ionis and GlaxoSmithKline (GSK) remain on their previously indicated timeline, Schimmer tells investors in a research note. The analyst at this point believes Alnylam's setback will be limited to revusiran and not read-through to other Gal-Nac programs or other TTR cardiomyopathy or polyneuropathy programs. He keeps an Overweight rating on Ionis with a $46 price target,
11/09/16
SBSH
11/09/16
NO CHANGE
SBSH
Citi sees Healthcare 'relief rally' after Trump win
Citi analyst Andrew Baum expects a "'relief rally" to drive near-term sector outperformance for names in the Healthcare space given the "inability of the Democrats to attain the Presidency, the House or Congress." Longer term, however, the analyst still sees "significant continued legislative risk" for pharma reimbursement. Baum prefers GlaxoSmithKline (GSK), AstraZeneca (AZN), Shire (SHPG) and Roche (RHHBY) among European majors and Bristol-Myers (BMY) and Eli Lilly (LLY) in the U.S.

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AYR

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