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BLPH

Bellerophon

$0.66 /

+0.0279 (+4.43%)

09:13
04/08/19
04/08
09:13
04/08/19
09:13

Bellerophon announces agreement with FDA on regulatory pathway for INOpulse

Bellerophon announced that it has reached agreement with the FDA on the regulatory approval pathway for INOpulse in patients with Pulmonary Hypertension associated with Interstitial Lung Disease, or PH-ILD. In January, the company reported positive results from cohort 1 of its ongoing Phase 2b randomized, double-blind, placebo-controlled clinical study of INOpulse for the treatment of PH-ILD. Subjects on active treatment demonstrated a statistically significant improvement of 34% in moderate to vigorous physical activity, or MVPA, as compared to subjects on placebo, as well as improvements in overall activity, oxygen saturation and additional functional measures. Based on these data and INOpulse's safety profile, the FDA agreed with Bellerophon on the use of MVPA as the primary endpoint in the pivotal Phase 3 study, as measured by a medical wearable continuous activity monitor. In addition, the agency agreed with the company's proposal that the Phase 2b study be amended to a Phase 2/3 trial. This agreement allows a seamless transition into Cohort 3 of iNO-PF, which will serve as the pivotal Phase 3 trial.

BLPH Bellerophon
$0.66 /

+0.0279 (+4.43%)

01/24/19 Maxim
Bellerophon initiated with a Buy at Maxim
01/24/19 Maxim
Bellerophon initiated with a Buy at Maxim

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Condor Hospitality Trust price target lowered to $5 from $11 at B. Riley FBR » 08:47
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Condor Hospitality Trust

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Beyond Meat

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SHOP

Shopify

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-33.65 (-8.04%)

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ReneSola

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HEXO

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$9.08 /

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ProShares Ultra S&P 500

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AFMD

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Aspen Technology downgraded to Neutral from Outperform at Baird » 08:44
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Aspen Technology

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LII

Lennox

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PVH Corp. price target lowered to $50 from $55 at Wells Fargo » 08:43
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PVH

PVH Corp.

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Randolph Bancorp

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Johnson Controls upgraded to Neutral from Sell at UBS » 08:43
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JCI

Johnson Controls

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New Residential price target lowered to $10.50 from $18 at BTIG » 08:43
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NRZ

New Residential

$4.36 /

-0.645 (-12.90%)

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LK

Luckin Coffee

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SPX Corporation upgraded to Buy from Neutral at UBS » 08:42
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SPXC

SPX Corporation

$28.43 /

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PNM Resources price target lowered to $40 from $48 at Wells Fargo » 08:42
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PNM

PNM Resources

$36.14 /

-1.91 (-5.02%)

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