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FGEN

FibroGen

$42.26

1.62 (3.99%)

, AZN

AstraZeneca

$48.50

-0.275 (-0.56%)

07:07
12/02/19
12/02
07:07
12/02/19
07:07

FibroGen announces roxadustat inclusion in China's NRDL

FibroGen reported roxadustat has been included on the updated National Reimbursement Drug List released by China's National Healthcare Security Administration. Roxadustat is included on the NRDL for the treatment of anemia in chronic kidney disease, covering patients who are non-dialysis-dependent as well as those who are dialysis-dependent. Roxadustat is the first hypoxia-inducible factor prolyl hydroxylase inhibitor to be approved anywhere in the world. HIF-PHIs are a brand-new class of drugs developed based on the groundbreaking science on the body's oxygen-sensing mechanism and adaptation to hypoxia which was awarded the 2019 Nobel Prize in Physiology or Medicine. Results from the two pivotal China roxadustat Phase 3 clinical trials were published in the New England Journal of Medicine earlier in 2019.The dialysis patient population in China, exceeding 600,000 patients, is the largest single-country cohort in the world and is growing. China also has the largest peritoneal dialysis population in the world, standing at approximately 14-15% of all dialysis patients, or 100,000 patients. Roxadustat, with its oral administration, is particularly well-suited for this population, as patients receive treatment at home. The addressable anemic non-dialysis population in China is equally sizable, estimated to be in excess of 2 million. FibroGen and AstraZeneca (AZN) are collaborating on the development and commercialization of roxadustat in China. Following market approval, FibroGen China, the Beijing-based subsidiary of FibroGen, Inc. and the marketing authorization holder of roxadustat in China, is responsible for commercial manufacturing, medical affairs, pharmacovigilance, and regulatory affairs. AstraZeneca China is responsible for promotional activities including marketing, market access, key accounts and sales.

FGEN

FibroGen

$42.26

1.62 (3.99%)

AZN

AstraZeneca

$48.50

-0.275 (-0.56%)

  • 02

    Dec

  • 04

    Dec

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    Dec

  • 09

    Dec

FGEN FibroGen
$42.26

1.62 (3.99%)

11/10/19
PIPR
11/10/19
NO CHANGE
PIPR
Piper Jaffray sees approval for FibroGen's roxadustat, but still has concerns
Piper Jaffray analyst Danielle Brill maintained a Neutral rating and $42 price target on FibroGen (FGEN). After getting more color on the MACE data from a meeting with management, speaking to a lead investigator, and listening to AstraZeneca's (AZN) call, Brill continues to expect approval of the drug, but also sees aspects that will drive debate, and a lack of clarity until FDA briefing documents for an Ad Com panel are released next year, which could be 6-10 months from now depending on priority. The analyst also still questions whether the labeling for the drug, if it is approved, will include a black box safety warning.
11/11/19
MZHO
11/11/19
NO CHANGE
Target $72
MZHO
Buy
FibroGen price target raised to $72 from $65 at Mizuho
Mizuho analyst Difei Yang raised her price target for FibroGen to $72 from $65 after the company reported MACE data from the global Phase 3 clinical trials of roxadustat. The data were positive with non-inferiority to placebo in the non dialysis-dependent setting and non-inferiority versus standard of care erythropoiesis stimulating agents in the dialysis-dependent setting, Yang tells investors in a research note. She believes the "path to approval is clear" and reiterates a Buy rating on FibroGen.
11/12/19
STFL
11/12/19
NO CHANGE
Target $71
STFL
Buy
FibroGen should be bought on yesterday's weakness, says Stifel
Stifel analyst Adam Walsh recommends buying shares of FibroGen following yesterday's 15% decline to $35.40. The analyst keeps a Buy rating on the name with a $71 price target. Even though FibroGen reported "approvable" MACE data, the shares remain "in a penalty box where we see no fundamental reasons," Walsh tells investors in a research note. The analyst, who believes roxadustat is highly likely to be approved, sees a "significant value mismatch" at current share levels.
11/12/19
JEFF
11/12/19
NO CHANGE
JEFF
Buy
Jefferies doesn't see 'anything new' in latest FibroGen short report
Jefferies analyst Michael Yee addressed some of the takeaways from "another short report" on FibroGen (FGEN), which he doesn't think includes "anything new." He has previously said that he expects ongoing "noise and confusion" about cardiovascular events in various populations, though he has talked to FibroGen, AstraZeneca (AZN) and many doctors and investigators, who "support a clear view of approval and safety here." The newest short report published on FibroGen highlights topics that are "generally known or mentioned in our previous reports," added Yee, who has a Buy rating on the shares.
AZN AstraZeneca
$48.50

-0.275 (-0.56%)

11/15/19
GUGG
11/15/19
NO CHANGE
Target $228
GUGG
Buy
BeiGene price target raised to $228 from $205 at Guggenheim
Guggenheim analyst Michael Schmidt raised his price target for BeiGene (BGNE) to $228 from $205 saying FDA approval of Brukinsa over three months ahead of the action date provides additional validation of the company's strategy and ability to execute. He thinks Brukinsa's label in mantle cell lymphoma indicates a "potentially best-in-class" product profile with "nuanced differences" compared to AstraZeneca's (AZN) Calquence and "significantly better" than AbbVie's (ABBV) Imbruvica. The analyst maintains a Buy rating on BeiGene shares.
11/22/19
LEER
11/22/19
INITIATION
Target $57
LEER
Outperform
AstraZeneca initiated with an Outperform at SVB Leerink
SVB Leerink analyst Andrew Berens initiated coverage of AstraZeneca with an Outperform rating and $57 price target.
11/22/19
11/22/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Duke Energy (DUK) initiated with a Neutral at Mizuho. 2. Lancaster Colony (LANC) initiated with a Neutral at DA Davidson. 3. LendingTree (TREE) initiated with an Overweight at JPMorgan. 4. Zoom Video (ZM) initiated with a Buy at Guggenheim. 5. AstraZeneca (AZN) initiated with an Outperform at SVB Leerink. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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TLRD

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$4.96

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NFLX

Netflix

$297.59

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, FOX

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NWSA

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LULU

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XLRN

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EVH

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