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ARDX

Ardelyx

$5.71

-0.08 (-1.38%)

15:27
09/12/19
09/12
15:27
09/12/19
15:27

Ardelyx says Ibsrela prescribing information includes Box Warning

Ardelyx announced that the FDA has approved Ibsrela, a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation, or IBS-C, in adults. Ibsrela is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. The FDA said to avoid use of Ibsrela in patients 6 years to less than 12 years of age. The safety and effectiveness of Ibsrela have not been established in pediatric patients less than 18 years of age. The full Prescribing Information includes a Box Warning about the risk of serious dehydration in pediatric patients. Reference Link

  • 12

    Sep

  • 16

    Sep

ARDX Ardelyx
$5.71

-0.08 (-1.38%)

04/08/19
PIPR
04/08/19
INITIATION
Target $15
PIPR
Overweight
Ardelyx initiated with an Overweight at Piper Jaffray
Piper Jaffray analyst Christopher Raymond started Ardelyx with an Overweight rating and $15 price target. The analyst sees a "sizeable disconnect" between Wall Street's view of tenapanor's potential versus that of the nephrology community. While the drug is not fully de-risked, there is enough data to get a "strong sense" of tenapanor's ultimate clinical profile, which confers $1B-plus revenue potential, Raymond tells investors in a research note. Nephrologists appear "fully aware of this drug's potential with swift and dramatic uptake projected if approved," adds the analyst. He thinks tenapanor's launch is "poised to be one of biotech's great product launches of 2021."
04/08/19
04/08/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Ardelyx (ARDX) initiated with an Overweight at Piper Jaffray. 2. Parker Drilling (PKD) initiated with an Outperform at Imperial Capital. 3. Frontdoor (FTDR) initiated with a Buy at Guggenheim. 4. Barnes & Noble Education (BNED) initiated with a Buy at Needham. 5. PlayAGS (AGS) initiated with a Buy at Roth Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
09/03/19
PIPR
09/03/19
NO CHANGE
Target $15
PIPR
Overweight
Ardelyx trial results a 'home run,' says Piper Jaffray
Piper Jaffray analyst Christopher Raymond said he is incrementally positive on Ardelyx and expects the shares to move up "sharply" after the company reported top-line data on lead drug tenapanor's AMPLIFY trial. The "home run" trial results showed that not only can adding tenapanor to a binder lower serum phosphorus significantly, it can do so relatively safely, said Raymond, who expects results from tenapanor's second Phase 3 pivotal trial by year-end and an NDA submission early next year. He keeps an Overweight rating and $15 price target on Ardelyx shares, which are up 15% to $3.92 in early trading.
09/09/19
PIPR
09/09/19
NO CHANGE
Target $15
PIPR
Overweight
Piper still sees 'substantial upside' in Ardelyx despite last week's rally
Piper Jaffray analyst Christopher Raymond says he still expects "substantial upside" in shares of Ardelyx even after last week's 43% move. While Amplify's more "real world" representation assuaged the key investor concern around tenapanor's adverse event-related discontinuations, the market still hasn't grasped tenapanor's full market potential in the renal setting, Raymond tells investors in a research note. Feedback from a recent nephrologist survey indicates "significant" awareness, interest and willingness to prescribe tenapanor, adds the analyst. He sees the drug's revenue potential "at well" over $1B in the U.S. alone. As such, Raymond continues to view his $15 target as a "more appropriate valuation" than current share levels. He maintains an Overweight rating on Ardelyx.

TODAY'S FREE FLY STORIES

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VRTX

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7.49 (4.25%)

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FBP

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ACC

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16:18
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GIFI

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ACC

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16:17
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LTXB

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VRTX

Vertex

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7.49 (4.25%)

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  • 19

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ADUS

Addus HomeCare

$84.43

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$NSD

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EFSC

Enterprise Financial

$41.74

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16:16
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UNM

Unum Group

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$NYE

NYSE Market Internals

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AMED

Amedisys

$133.91

-1.46 (-1.08%)

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UPS

UPS

$118.60

1.27 (1.08%)

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Stamps.com

$76.18

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SITE

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$78.36

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SPCB

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EHC

Encompass Health

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ADC

Agree Realty

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ENSG

Ensign Group

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  • 13

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RLI

RLI Corp.

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  • 21

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XAIR

Beyond Air

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VRTX

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ADC

Agree Realty

$77.07

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  • 22

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CRY

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$24.01

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  • 30

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