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GILD

Gilead

16:02
08/10/17
08/10
16:02
08/10/17
16:02

Gilead says FDA grants priority review for NDA for bictegravir combo

Gilead Sciences announced that the U.S. Food and Drug Administration has granted priority review for the company's New Drug Application for an investigational, fixed-dose combination of bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide, a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and FDA has set a target action date under the Prescription Drug User Fee Act of February 12, 2018. The NDA is supported by data from four Phase 3 studies that evaluated the fixed-dose combination among treatment-naive patients and among virologically suppressed patients. A marketing application for BIC/FTC/TAF is also under review in the European Union, and was validated by the European Medicines Agency in July. 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.

GILD Gilead

07/13/17
BARD
07/13/17
NO CHANGE
Target $87
BARD
Outperform
Baird likes Gilead heading into Q2 earnings
Baird analyst Brian Skorney said he likes Gilead heading into Q2 earnings. The analyst said Hep-C sales should beat estimates and predicts its sales decline should be approaching a plateau, which would result in upside to the shares. He said the operating results could provide much needed stability, which should also result in upside. Skorney maintained his Outperform rating and $87 price target on Gilead shares.
07/14/17
LEER
07/14/17
NO CHANGE
LEER
Acquisition of Incyte would make sense for Gilead, says Leerink
Leerink analyst Geoffrey Porges, who noted he has "written extensively about the imperative for Gilead to diversify their portfolio and secure additional pipeline programs," said in a new note to investors that he believes an acquisition of Incyte (INCY) would make sense for Gilead (GILD). At a "reasonable acquisition premium," Gilead could pay $173-$187 per share for Incyte and its earnings would be diluted through 2018, but thereafter would be increased by such a deal, estimated Porges. The analyst, who concluded that Incyte presents a high-risk/high-reward option for Gilead, keeps a Market perform rating on Gilead shares.
07/27/17
JPMS
07/27/17
NO CHANGE
Target $85
JPMS
Overweight
Gilead price target raised to $85 from $80 at JPMorgan
JPMorgan analyst Cory Kasimov raised his price target for Gilead Sciences to $85 saying the Q2 beat-and-raise quarter is "encouraging." The HCV franchise is still in decline, but the "resiliency this quarter helps further fuel ample cash generation," Kasimov tells investors in a post-earnings research note. He keeps an Overweight rating on the shares.
07/27/17
COWN
07/27/17
NO CHANGE
Target $90
COWN
Outperform
Gilead results a 'welcome' beat and raise, says Cowen
Cowen analyst Phil Nadeau called the Gilead results a "welcome beat and raise" for what is a very cheap name. The analyst said it may be too early to confidently say the business has stabilized, but his discounted free cash flow analysis suggests the shares remain undervalued. Nadeau reiterated his Outperform rating and $90 price target on Gilead shares.

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