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GILD

Gilead

$63.84

-0.23 (-0.36%)

08:43
03/26/19
03/26
08:43
03/26/19
08:43

Gilead announces Japan's MHLW approves Biktarvy for HIV-1 treatment

Gilead Sciences announced that Japan's Ministry of Health, Labour and Welfare has approved Biktarvy, a once-daily single tablet regimen for the treatment of HIV-1 infection. Biktarvy is the first HIV product that Gilead will launch and commercialize in Japan directly through its local subsidiary, Gilead Sciences K.K. In the United States, Biktarvy has a Boxed Warning in its product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for U.S. Important Safety Information as well as the Biktarvy Indication. The approval of Biktarvy is supported by data from four Phase 3 studies: Studies 1489 and 1490 in treatment-naive HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a diverse population of 2,415 participants on Biktarvy or an active comparator, including a wide range of adult age groups and races/ethnicities. Biktarvy met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies developed treatment-emergent virologic resistance while taking Biktarvy, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking Biktarvy were diarrhea, nausea and headache.

  • 18

    May

GILD Gilead
$63.84

-0.23 (-0.36%)

03/07/19
PIPR
03/07/19
NO CHANGE
Target $75
PIPR
Neutral
Gilead Truvada conversion still looks challenging, says Piper Jaffray
Gilead Sciences reported positive data from the Phase III Discover trial and the efficacy data demonstrated non-inferiority of Descovy to Truvada for HIV pre-exposure prophylaxis, Piper Jaffray analyst Tyler Van Buren tells investors in a research note. The analyst, however, believes the numerical improvements appear small and wonders if a year will be enough time to convert the majority of a $2.6B Truvada U.S. sales franchise prior to generic entry in 2021 In order for this conversion to be "exceedingly" successful, the safety advantage needs to be "dramatic" given the anticipated low price of generic Truvada, says Van Buren. He's still uncertain as to how well it will go and keeps a Neutral rating on Gilead with a $75 price target.
03/14/19
BMOC
03/14/19
INITIATION
Target $78
BMOC
Outperform
Gilead initiated with an Outperform at BMO Capital
BMO Capital analyst Matthew Luchini started Gilead Sciences with an Outperform rating and $78 price target. The company's HIV franchise should remain dominant for at least the next several years while a growing dividend and continued buybacks "provide investors with a baseline return," Luchini tells investors in a research note. Further, the analyst believes current levels provide an attractive entry point.
03/15/19
03/15/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Simmons First National (SFNC) initiated with a Buy at DA Davidson. 2. Amgen (AMGN) and Gilead (GILD) initiated with an Outperform at BMO Capital. 3. Rocket Pharmaceuticals (RCKT) initiated with a Buy at BofA/Merrill. 4. Urovant Sciences (UROV) initiated with a Buy at SunTrust. 5. Spectrum (SPPI) assumed with a Buy at Jefferies. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
03/17/19
PIPR
03/17/19
NO CHANGE
Target $75
PIPR
Neutral
Gilead HIV drugs' price increase 30% lower than prior years, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren notes that as expected, effective March 16th, Gilead raised list prices of the company's top 6 selling HIV antiviral drugs by 4.9% which includes Atripla, Biktarvy, Descovy, Genvoya, Odefsey, and Truvada. Notably, the price increases were roughly 30% lower than what has been observed in prior years and likely reflects the recent increasing pressure on drug pricing, he contends. The analyst also notes that these increases are well below the high single digit year over year price increases that have been observed with other companies, which Gilead can afford due to strong volume growth of its next generation TAF-based regimens. Van Buren reiterates a Neutral rating and $75 price target on the shares.

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