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CCXI

ChemoCentryx

$8.06

0.13 (1.64%)

05:06
11/26/19
11/26
05:06
11/26/19
05:06

ChemoCentryx, VFMCRP say pivotal phase-III ADVOCATE trial met primary endpoints

Vifor Fresenius Medical Care Renal Pharma, or VFMCRP, and ChemoCentryx announced positive topline data from the pivotal phase-III ADVOCATE trial of avacopan, an orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis). This global study, in which a total of 331 patients with ANCA vasculitis were enrolled, met both of its primary endpoints, disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS. Remission was defined as a BVAS score of zero and being off glucocorticoid treatment for ANCA vasculitis for at least the preceding four weeks. BVAS remission at week 26 was achieved in 72.3% of the avacopan treated subjects vs. 70.1% of subjects in the glucocorticoid standard of care control group. Sustained remission at 52 weeks was observed in 65.7% of the avacopan treated patients vs. 54.9% in the glucocorticoid standard of care control group, achieving both non-inferiority and superiority to glucocorticoid standard of care. Importantly, subjects who received avacopan experienced additional benefits compared to those in the glucocorticoid standard of care control group. These benefits, assessed as pre-specified secondary endpoints, include: Significant reduction in glucocorticoid-related toxicity; Significant improvement in kidney function in patients with renal disease at baseline; Improvements in health-related quality of life metrics. The topline safety results revealed an acceptable safety profile in this serious and life threatening disease with fewer subjects having serious adverse events in the avacopan group than in the glucocorticoid standard of care control group. A full analysis of the data is underway and expanded results are expected to be announced in the coming weeks. "These results exceed our expectations," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Today we mark the dawn of a new and historic period in the lives of ANCA vasculitis patients. This day we have for the first time demonstrated that a highly targeted therapy aimed at the very center of the ANCA disease process is superior to the traditional approach of broad immune suppression therapy; a therapy which the present findings may make obsolete. Until now ANCA vasculitis patients have had to endure regimens that contain chronic high doses of steroids and all their noxious effects, but with today's data it is clear that the time of making patients sick with steroid therapy in an attempt to make their acute vasculitis better may at last be over. Working with our partner VFMCRP, we plan to make regulatory submissions for full marketing approval to both the European Medicines Agency and the FDA in 2020."

CCXI ChemoCentryx
$8.06

0.13 (1.64%)

06/06/19
RAJA
06/06/19
NO CHANGE
Target $17
RAJA
Strong Buy
ChemoCentryx price target lowered to $17 from $24 at Raymond James
Raymond James analyst Steven Seedhouse removed hidradenitis suppurativa from his model for ChemoCentryx (CCXI) after InflaRx (IFRX) reported that its Phase IIb trial for C5a antibody IFX-1 failed, leading him to lower his price target on the shares to $17 from $24. However, he keeps a Strong Buy rating on ChemoCentryx shares and said he would be a buyer amid the weakness, citing Phase 2 data for avacopan in AAV and a near-term Phase 3 data readout for AAV in Q4.
09/12/19
JPMS
09/12/19
UPGRADE
Target $14
JPMS
Overweight
ChemoCentryx upgraded to Overweight from Neutral at JPMorgan
JPMorgan analyst Anupam Rama upgraded ChemoCentryx to Overweight from Neutral with a price target of $14, down from $16. The analyst sees a favorable risk/reward profile at current share levels.
09/12/19
JPMS
09/12/19
UPGRADE
Target $14
JPMS
Overweight
JPMorgan upgrades ChemoCentryx to Overweight ahead of Phase 3 readout
JPMorgan analyst Anupam Rama upgraded ChemoCentryx to Overweight from Neutral with a price target of $14, down from $16. Following a round of key opinion leader and physician discussions, the analyst believes the Phase 3 Advocate study of avacopan in associated vasculitis has a high probability of success. The share pressure dating back to the spring has created a favorable risk/reward scenario for shares of ChemoCentryx ahead of the Phase 3 results, Rama tells investors in a research note. The analyst expects the readout in the mid-to-late Q4 timeframe.
10/15/19
JPMS
10/15/19
NO CHANGE
JPMS
Overweight
ChemoCentryx can rally 110% on positive Advocate results, says JPMorgan
JPMorgan analyst Anupam Rama says shares ChemoCentryx can rally 90%-110% on positive Phase 3 Advocate trial results of avacopan in ANCA-associated vasculitis, expected in Q4. The analyst sees share downside of 45%-80% on negative results. Rama continues to believe that Advocate has a high probability of success and that the totality of data will be key for adoption. He keeps an Overweight rating on ChemoCentryx shares.

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VEEV

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BLDR

Builders FirstSource

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S

Sprint

$5.40

-0.145 (-2.62%)

, TMUS

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$75.90

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WEN

Wendy's

$21.72

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BANX

StoneCastle

$22.99

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AIZ

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XAIR

Beyond Air

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MSFT

Microsoft

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, UPWK

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AMZN

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SNY

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UNH

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VIAC

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FTSV

Forty Seven

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FATE

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TTWO

Take-Two

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THO

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BANX

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WEN

Wendy's

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INVH

Invitation Homes

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BRO

Brown & Brown

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PYX

Pyxus

$7.40

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, PM

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PM

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TSN

Tyson Foods

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AES

AES Corp.

$18.79

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