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GILD

Gilead

$64.70

0.58 (0.90%)

08:18
06/12/17
06/12
08:18
06/12/17
08:18

Gilead submits NDA for Bictegravir, Emtricitabine, Tenofovir Alafenamide regimen

Gilead Sciences announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults. BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naive adult patients and among virologically suppressed adult patients who switched regimens. The NDA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir among treatment-naive patients and among virologically suppressed patients switching from an existing antiretroviral regimen with dolutegravir. A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor. Gilead plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in Q3. Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.

  • 13

    Jun

GILD Gilead
$64.70

0.58 (0.90%)

05/30/17
JPMS
05/30/17
NO CHANGE
JPMS
Overweight
JPMorgan 'generally encouraged' by Gilead bictegravir data
After Gilead (GILD) announced top-line data from four Phase 3 studies of its HIV combo regimen containing bictegravir, JPMorgan analyst Cory Kasimov said he was "generally encouraged by the news, though not entirely surprised" given the previously communicated Phase 2 results. As he has previously noted, Kasimov thinks the launch of the bictegravir combo in 2018 could be key for Gilead to help maintain market share in the face of continued growth of GlaxoSmithKline's (GSK) dolutegravir combo and a wave of patent expirations. The analyst keeps an Overweight rating on Gilead shares.
05/30/17
LEER
05/30/17
NO CHANGE
Target $74
LEER
Market Perform
Gilead HIV combo data should reassure investors, says Leerink
Leerink analyst Geoffrey Porges said Gilead's (GILD) Phase 3 data for its HIV combination treatment featuring bictegravir should "provide significant reassurance for investors" given that the drug is an essential part of the company's HIV strategy and portfolio and was found to be equal to, though not better than, the "gold standard," namely GlaxoSmithKline's (GSK) dolutegravir combo. Porges, who attributes $12-13 per share in value from bictegravir in his current model for Gilead, notes that his peak global forecast of $10.6B for bictegravir containing combination revenue is nearly double the current consensus peak sales estimate of $5.6B. Porges keeps a Market Preform rating and $74 price target on Gilead shares.
04/25/17
JMPS
04/25/17
NO CHANGE
JMPS
Johsnson &Johnson data positive for Achillion, says JMP Securities
JMP Securities analyst Liisa Bayko says that data on a triple combination HCV treatment presented by Johnson & Johnson (JNJ) yesterday is positive for Achillion (ACHN). The analyst noted that the triple combination includes Achillion's odalasvir and that the six week treatment regimen is shorter than the eight weeks required for Gilead's (GILD) Harvoni. The analyst says that Achillion's stock dropped sharply yesterday because there was disappointment over the combination's efficacy in genotype 3 patients. However, she says that such patients only represent 10% of the total, and she says that Achillion can "conservatively" obtain peak royalty revenue of about $100M from its drug. Bayko keeps a $13 price target and an Outperform rating on the shares.
04/25/17
WELS
04/25/17
NO CHANGE
WELS
Gilead Q1 results poised to beat expectations, says Wells Fargo
After analyzing prescription data for January and February, Wells Fargo says that prescriptions of Gilead's HIV and HCV drugs were tracking ahead of expectations. The firm says the company's Q1 results appear on track to beat expectations.

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MKSI

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UQM

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GS

Goldman Sachs

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VICL

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LGND

Ligand

$140.31

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LGND

Ligand

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MBI

MBIA

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RBCN

Rubicon

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ANCB

Anchor Bancorp

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GIFI

Gulf Island Fabrication

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MPB

Mid Penn Bancorp

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CALD

Callidus Software

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GIFI

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GE

General Electric

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NRE

Northstar Realty Europe

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FHN

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LII

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TBNK

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TRTN

Triton International

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16:30
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Options
Preliminary option volume of 21.1M today »

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