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FGEN

FibroGen

19:51
10/25/18
10/25
19:51
10/25/18
19:51

FibroGen presents two phase 3 study results of Roxadustat in CKD treatment

FibroGen announced the presentation of results from two Phase 3 multi-center, randomized, controlled clinical trials of roxadustat for the treatment of anemia associated with chronic kidney disease, or CKD, conducted in China at the American Society of Nephrology Kidney Week 2018 annual meeting in San Diego, California. Roxadustat is a first-in-class oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in late-stage development for the treatment of anemia associated with CKD both in patients on dialysis and in patients not on dialysis. "The results of two Phase 3 trials in dialysis-dependent and non-dialysis-dependent CKD patients in China showed roxadustat effectively corrected and maintained hemoglobin levels, and are the basis of our new drug application currently under review by the National Medical Products Administration. These results are consistent with findings from multiple Phase 3 clinical studies reported to date by FibroGen and our partners, supporting roxadustat as the potential first oral drug for the treatment of anemia associated with chronic kidney disease, a serious and potentially life-threatening condition," said Peony Yu, M.D., Chief Medical Officer of FibroGen. "If approved in China, roxadustat will be the first HIF-PHI available to help CKD patients with anemia, and patients in China could be first to gain access to treatment with roxadustat."

FGEN FibroGen

05/15/18
MZHO
05/15/18
UPGRADE
Target $61
MZHO
Buy
FibroGen upgraded to Buy from Neutral at Mizuho
Mizuho analyst Difei Yang upgraded FibroGen to Buy with an unchanged price target of $61. With a "solid" cash position, the company continues to make progress on its research and development pipeline, Yang tells investors in a research note. The analyst expects top-line Phase 3 data from Roxadustat in chronic kidney disease in Q4 and a potential regulatory approval in China is expected by year-end 2018. Yang believes believe FibroGen is likely to gain the first approval in new generation anemia drugs.
06/19/18
MZHO
06/19/18
NO CHANGE
Target $74
MZHO
Buy
FibroGen price target raised to $74 from $61 at Mizuho
Mizuho analyst Difei Yang raised her price target for FibroGen to $74 after taking a closer look at pipeline product Pamrevlumab, currently in development for the treatment of diseases associated with fibrosis. The analyst is encouraged by recent positive data in two indications: idiopathic pulmonary fibrosis and pancreatic cancer. The data lends credibility to the compound's mechanism of action, Yang tells investors in a research note. She reiterates a Buy rating on FibroGen.
08/08/18
SBSH
08/08/18
DOWNGRADE
Target $71
SBSH
Neutral
FibroGen downgraded to Neutral from Buy at Citi
Citi analyst Joel Beatty downgraded FibroGen to Neutral while raising his price target for the shares to $71 from $64. The analyst believes Phase 3 Roxadustat success is mostly priced into the shares at current valuation levels. He cites valuation for the downgrade to Neutral.
09/07/18
MSCO
09/07/18
INITIATION
Target $9
MSCO
Equal Weight
Akebia resumed with an Equal Weight at Morgan Stanley
Morgan Stanley analyst David Lebowitz resumed coverage of Akebia (AKBA) with an Equal Weight rating and $9 price target, stating that value is primarily driven by the potential of vadadustat as a treatment for anemia associated with chronic kidney disease. Vadadustat is a year behind FibroGen's (FGEN) competing HIF-inhibitor roxadustat and that lead could be an advantage if the data for the two drugs is not sufficiently differentiated, said Lebowitz.

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IOVA

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LB

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UNM

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PGTI

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LB

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ATRA

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NGD

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KIN

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WEN

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ALLO

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