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AKBA

Akebia

$4.33

0.185 (4.46%)

16:47
10/15/19
10/15
16:47
10/15/19
16:47

Akebia sues CMS over action rescinding Medicare part D coverage of Auryxia

Akebia Therapeutics, Inc. filed a complaint in federal district court against the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services. The lawsuit challenges a September 2018 decision by CMS that rescinded Medicare Part D coverage of Auryxia, Akebia's FDA-approved drug, when used for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. The legal action also seeks to reverse a related decision by CMS that imposed a prior authorization requirement for Auryxia when used for the control of serum phosphorus levels in adult patients with CKD on dialysis. In the complaint, Akebia asks the court to restore coverage of Auryxia for the IDA Indication and to remove the prior authorization requirement for the Hyperphosphatemia Indication.

AKBA Akebia
$4.33

0.185 (4.46%)

05/10/19
PIPR
05/10/19
NO CHANGE
Target $22
PIPR
Overweight
Akebia shares should be bought at the open, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond recommends purchase of Akebia Therapeutics (AKBA) shares at today's opening bell. Despite "one of the worst communication jobs we have ever witnessed with respect to a major data event," FibroGen's (FGEN) roxadustat data appear positive in that the drug has shown a statistically non-inferior safety profile versus controls in both pre-dialysis and dialysis settings, Raymond tells investors in a research note. The analyst believes that should roxadustat prove safe as well as efficacious, the agent should pave the way for the hypoxia-inducible-factor class as a novel anemia correction approach in renal disease. While FibroGen "seemed almost determined to confuse investors with their presentation of the data, we think that thesis remains intact," says the analyst. Raymond keeps an Overweight rating on Akebia with a $22 price target.
06/17/19
PIPR
06/17/19
NO CHANGE
PIPR
Piper says buy Akebia before market figures out competitive positoin
After hosting an investor call with Akebia Therapeutics (AKBA) CEO John Butler, Piper Jaffray analyst Christopher Raymond thinks vadadustat's competitive position relative to FibroGen's (FGEN) roxadustat is "stronger, not weaker now." As such, the analyst recommends buying shares of Akebia "before the market begins to figure this out." Raymond left the call incrementally confident in vadadustat "on a number of levels," namely its approvability given Akebia's alignment with FDA on trial design and statistical analysis. He keeps an Overweight rating on the shares with a $22 price target.
07/24/19
HCWC
07/24/19
NO CHANGE
Target $19
HCWC
Buy
Akebia shares at 'excellent entry point,' says H.C. Wainwright
After Akebia (AKBA) announced that its Japanese partner on vadadustat has submitted a New Drug Application in Japan that supports approval for anemia due to chronic kidney disease in both non-dialysis and dialysis patients, H.C. Wainwright analyst Ed Arce noted that this represents the first regulatory submission for vadadustat. The current valuation, with shares trading near 52-week lows, presents "an excellent entry point" given that the primary bear thesis depends on the first-to-market advantage of Fibrogen's (FGEN) roxadustat, which Arce views as "fundamentally flawed," he tells investors. In light of the JNDA submission, as well as the current timeline, Arce pushed back his U.S. and EU market launch and initial sales estimates to early 2022 and trimmed his price target on Akebia shares to $19 from $21, but he keeps a Buy rating on the stock.
08/08/19
PIPR
08/08/19
NO CHANGE
Target $22
PIPR
Overweight
Akebia's Auryxia 'a nice little growth story,' says Piper Jaffray
Piper Jaffray analyst Christopher Raymond reiterates an Overweight rating and $22 price target on Akebia's shares following the company's Q2 update. While the analyst is "gratified" to see the shares up 11% on a robust Auryxia print, the analyst believes this company still has an EV $300M, despite possessing a $130M/year approved drug, and a potential $1B product - vadadustat - with Phase 3 readouts next year. Raymond thinks the totality of the data would indicate that, despite being the second HIF to the market, vadadustat is differentiated enough, and the market is large enough that vadadustat has blockbuster potential. In the meantime, he would argue this stock's current valuation is more than justified by Auryxia alone

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BABA

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PING

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EW

Edwards Lifesciences

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3.04 (1.27%)

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Daimler AG

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CSCO

Cisco

$48.44

0.06 (0.12%)

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UBS

UBS

$12.16

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CYDY

CytoDyn

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CPE

Callon Petroleum

$4.47

-0.175 (-3.77%)

, CRZO

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$7.73

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Callon Petroleum

$4.47

-0.175 (-3.77%)

CRZO

Carrizo Oil & Gas

$7.73

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GECC

Great Elm Capital

$8.23

-0.02 (-0.24%)

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CSCO

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$48.44

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Sanmina

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$48.44

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Jabil

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BCLI

BrainStorm

$3.88

0.05 (1.31%)

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RMBL

RumbleON

$1.50

-0.83 (-35.62%)

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AXNX

Axonics

$25.49

0.53 (2.12%)

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EPAM

Epam Systems

$200.74

0.85 (0.43%)

06:09
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FENG

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ATHX

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CSCO

Cisco

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GRUB

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WTT

Wireless Telecom Group Inc

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