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AVDL

Avadel Pharmaceuticals

$4.37

-0.18 (-3.96%)

08:35
10/15/18
10/15
08:35
10/15/18
08:35

Avadel data shows increase in duration of FUSP with Noctiva

Avadel Pharmaceuticals presented data from two abstracts from Phase 3 clinical trials of NOCTIVA at the American Urogynecologic Society Annual Scientific Meeting, Pelvic Floor Disorder Week 2018 in Chicago, Illinois from October 9-13. These data show that patients treated with NOCTIVA Nasal Spray - the lowest effective dose of desmopressin - experienced an increase in both duration of first uninterrupted sleep period and percentage of nights with one or no nocturic voids, and NOCTIVA's safety profile was well-tolerated. These results show that NOCTIVA is an effective therapy in patients with nocturia due to nocturnal polyuria. The efficacy of NOCTIVA on FUSP and safety, as secondary endpoints, were evaluated in patients age 50 years and older with nocturia due to nocturnal polyuria in two Phase 3 randomized, double-blind pivotal studies. FUSP is defined as elapsed time from bedtime to first NOV or awakening if no void occurred. Patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA, or a placebo for 12 weeks. The baseline average FUSP for all groups was 2.4 hours. In the NOCTIVA 1.66 mcg group, FUSP increased by 1.8 hours to 4.2 hours, and in the NOCTIVA 0.83 mcg group, FUSP increased by 1.6 hours to 4.0 hours, which was statistically significant compared to placebo. Incidence and severity of adverse events were similar to placebo, and the incidence of hyponatremia, defined as serum sodium less than or equal to125 mmol/L regardless of symptoms or less than130 mmol/L with symptoms, was low for both doses. No patients treated with 0.83 mcg experienced serum sodium less than or equal to125 mmol/L. These results demonstrate that NOCTIVA is an effective therapy with a well-tolerated safety profile in patients with nocturia due to nocturnal polyuria and may provide longer periods of uninterrupted sleep.

AVDL Avadel Pharmaceuticals
$4.37

-0.18 (-3.96%)

08/07/18
JMPS
08/07/18
DOWNGRADE
JMPS
Market Perform
Avadel Pharmaceuticals downgraded to Market Perform from Outperform at JMP Securities
08/07/18
08/07/18
DOWNGRADE
Target $7

Hold
Avadel Pharmaceuticals downgraded to Hold on lower Noctiva sales at SunTrust
As previously reported, SunTrust analyst John Boris downgraded Avadel Pharmaceuticals to Hold from Buy after the company lowered its 2018 revenue guidance for Noctiva. Following the company's Q2 report, Boris cut his Noctiva sales estimate by about 35% and lowered his price target to $7 from $13, citing the lower Noctiva sales view and rising competition for Avadel's Eclat non-strategic assets.
08/07/18
RHCO
08/07/18
DOWNGRADE
RHCO
Hold
Avadel Pharmaceuticals downgraded to Hold from Buy at SunTrust
03/09/18
LTCO
03/09/18
NO CHANGE
Target $24
LTCO
Buy
Avadel Pharmaceuticals price target lowered to $24 from $30 at Ladenburg
Ladenburg Thalmann analyst Matthew Kaplan lowered his price target for Avadel Pharmaceuticals to $24 citing a lack of clarity with respect to the FT 218 new drug application filing. The analyst, however, keeps a Buy rating on the shares following the company's Q4 results.

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TJX

TJX

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TPR

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AFL

Aflac

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ROST

Ross Stores

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RL

Ralph Lauren

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RH

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PVH

PVH Corp.

$96.91

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JWN

Nordstrom

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NKE

Nike

$89.51

-0.52 (-0.58%)

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EYE

National Vision

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LB

L Brands

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BABA

Alibaba

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0.26 (0.14%)

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ENR

Energizer

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DDOG

Datadog

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NKE

Nike

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6.63 (0.37%)

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Report from Bloomberg.

NKE

Nike

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AMZN

Amazon.com

$1,778.33

6.63 (0.37%)

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HPE

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