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FGEN

FibroGen

$52.45

1.35 (2.64%)

16:04
05/21/18
05/21
16:04
05/21/18
16:04

FibroGen announces updated results from PRAISE study at ATS

FibroGen announced that updated results from the company's randomized, double-blind, placebo-controlled Phase 2b PRAISE study of pamrevlumab in patients with idiopathic pulmonary fibrosis, or IPF, were presented in several poster presentations at the American Thoracic Society, or ATS 2018. In total, the company is presenting four abstracts on pamrevlumab. Pamrevlumab, a proprietary first-in-class antibody targeting connective tissue growth factor, or CTGF, currently being developed for the treatment of fibrotic and fibroproliferative disorders, has demonstrated favorable results in slowing disease progression as measured by forced vital capacity, or FVC in IPF patients in two Phase 2 trials. The poster presentation at ATS presents additional results demonstrating that pamrevlumab treatment achieved a statistically significant reduced rate of progression of lung fibrosis compared to placebo using quantitative high resolution computed tomography, or HRCT. The pamrevlumab findings are consistent with reported results from a prior Phase 2 study in IPF. Quantitative lung fibrosis, or QLF measurements appear to be an objective method for quantifying the change in lung fibrosis captured by HRCT. In PRAISE, the change in QLF volumes in pamrevlumab-treated patients over 48 weeks was significantly less than in patients on placebo, and the treatment difference between pamrevlumab vs placebo was observed as early as six months. The change from baseline in QLF volume for pamrevlumab-treated patients was 24.8 ml vs 86.4 ml for placebo at Week 24, with a treatment difference of -61.6 ml. The change in QLF volume from baseline to 48 weeks was 75.4 ml in pamrevlumab-treated patients vs 151.5 ml from baseline to 48 weeks in patients on placebo, with a treatment difference of -76.2 ml. These QLF results on pamrevlumab's reduction of fibrotic build up in the lungs of IPF patients correlate with attenuation of the rate of decline in FVC % predicted, the primary endpoint of this study, with Spearman's correlation coefficient of -0.64. The PRAISE Phase 2b study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of pamrevlumab in patients with mild-to-moderate IPF. One hundred and three patients were randomized to receive either 30 mg/kg of pamrevlumab or placebo intravenously every three weeks. Lung function assessments were conducted at baseline and at Weeks 12, 24, 36, and 48. Quantitative HRCT assessments were performed at baseline and at Weeks 24 and 48. Additional secondary endpoints of the study were disease progression, health-related quality of life, and safety.

FGEN FibroGen
$52.45

1.35 (2.64%)

11/15/17
HCWC
11/15/17
NO CHANGE
Target $24
HCWC
Buy
Akebia recent selloff not based on fundamentals, says H.C. Wainwright
H.C. Wainwright analyst Ed Arce notes that since the close on November 8, shares of FibroGen (FGEN) are down 17% while Akebia Therapeutics (AKBA) is down 21.3%. He attributes some of the weakness to FibroGen's Q3 earnings call, in which concerns arose that cardiovascular events in the large Phase 3 roxadustat cardiovascular outcomes trials are accruing too slowly. The analyst believes this has no fundamental bearing on Akebia or vadadustat, however. He keeps a Buy rating on the shares with a $24 price target.
12/18/17
PIPR
12/18/17
INITIATION
Target $26
PIPR
Overweight
Akebia initiated with an Overweight at Piper Jaffray
Piper Jaffray analyst Christopher Raymond initiated Akebia (AKBA) with an Overweight rating and a price target of $26. The analyst cites the company's "combination of sound biology, clean safety, meaningful unmet medical need and an attractive relative valuation". While the near term prospects for Akebia revolve around first-to- market player Fibrogen (FGEN) in the HIF space, the analyst contends, Akebia can generate its own share of anemia market once its lead compound vadadustat is approved.
02/28/18
LEER
02/28/18
NO CHANGE
Target $88
LEER
Outperform
FibroGen price target raised to $88 from $80 at Leerink
Leerink analyst Geoffrey Porges raised his price target for FibroGen to $88 from $80 after the company n reported Q4 financial and operational results, and provided updated later timing for the U.S. roxadustat phase III trials and approval in chronic kidney disease. The analyst reiterates an Outperform rating on the shares.
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.

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SIGA

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