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NVO

Novo Nordisk

$47.44

-0.32 (-0.67%)

06:50
08/20/18
08/20
06:50
08/20/18
06:50

Novo Nordisk says PIONEER 5 trial of Oral semaglutide achieved primary objective

Novo Nordisk announced the headline results from PIONEER 5, a phase 3a trial with oral semaglutide in adults with type 2 diabetes and moderate renal impairment. Oral semaglutide is an investigational GLP-1 analogue taken once daily as a tablet. The 26-week trial investigated the efficacy and safety of 14 mg oral semaglutide compared with placebo in 324 people with type 2 diabetes and moderate renal impairment inadequately controlled with metformin, sulfonylurea alone or in combination with metformin, or basal insulin alone or in combination with metformin. Two distinct statistical approaches to evaluating the effects of oral semaglutide were applied in the PIONEER 5 trial; a primary statistical approach required by recent regulatory guidance evaluating the effect regardless of discontinuation of treatment and use of rescue medication, and a secondary statistical approach describing the effect while on treatment and without use of rescue medication. The trial achieved its primary objective according to the primary statistical approach by demonstrating statistically significant and superior reductions in HbA1c with oral semaglutide compared to placebo at week 26. Furthermore, people treated with oral semaglutide achieved statistically significant and superior reductions in body weight compared to placebo at week 26. When applying the secondary statistical approach, people treated with oral semaglutide experienced a statistically significantly greater reduction in HbA1c of 1.1% compared to 0.1% with placebo. Reduction in body weight was statistically significantly greater with oral semaglutide at week 26, with a reduction of 3.7 kg compared to 1.1 kg with placebo. In this 26-week trial, oral semaglutide was well-tolerated in people with moderate renal impairment, with a profile consistent with GLP-1-based therapies. "The results from PIONEER 5 showed that oral semaglutide is efficacious and has a solid safety profile in people with type 2 diabetes and moderate renal impairment, thereby further expanding the solid clinical profile of oral semaglutide," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

  • 25

    Aug

  • 12

    Sep

NVO Novo Nordisk
$47.44

-0.32 (-0.67%)

07/19/18
BMOC
07/19/18
NO CHANGE
Target $80
BMOC
Market Perform
Eli Lilly to have a 'good Q2' on beats from launch franchises, says BMO Capital
BMO Capital analyst Alex Arfaei raised his price target on Eli Lilly to $80 from $78 ahead of its Q2 earnings, saying the company will have a "good" quarter on "beats from its launch franchises Trulicity, Jardiance, and Basaglar". The analyst also keeps his Market Perform rating, adding that while the the pipeline potential of its Galcanezumab and Tanezumab drugs is promising, he believes investors are underappreciating the headwinds around its diabetes program. He see higher risks of an increased biosimilar erosion for Humalog from Sanofi's (SNY) Admelog, and Trulicity competitive pressure from Novo's (NVO) Ozempic in 2019.
07/02/18
BERN
07/02/18
UPGRADE
BERN
Outperform
Novo Nordisk upgraded to Outperform from Market Perform at Bernstein
06/01/18
ROTH
06/01/18
NO CHANGE
Target $400
ROTH
Buy
Roth Capital ups Madrigal price target to $400, examines possible M&A scenarios
Roth Capital analyst Yasmeen Rahimi noted that Madrigal Pharmaceuticals' (MDGL) "impressive" NASH resolution results published yesterday resulted in the stock's value being pushed up to make it the highest among "purely NASH" companies. Among large pharma companies, Rahimi believes those with the strongest metabolic franchises, large R&D teams, and sales forces focused on endocrinologists, gastroenterologists, and hepatologists likely have eyes on NASH assets, listing Merck (MRK), AstraZeneca (AZN), Eli Lilly (LLY) and Novo Nordisk (NVO) as examples. The historical acquisition price for NASH assets ranges from $200M to $1.7B, but Rahimi argues that Madrigal "can set the highest NASH price tag yet," estimating a potential takeout valuation of $5.6B. Rahimi raised her price target on Madrigal shares to $400 from $210 and keeps a Buy rating on the stock.
04/05/18
RHCO
04/05/18
NO CHANGE
Target $101
RHCO
Buy
Eli Lilly supported by positive oncology and diabetes findings, says SunTrust
SunTrust analyst John Boris keeps his Buy rating and $101 price target on Eli Lilly (LLY), citing the latest developments in Oncology and Diabetes. In Oncology, Boris points to the positive Overall Survival and Progression Free Survival data for Cyramza in second-line hepatocellular carcinoma, though he sees the commercial opportunity in Hepatocellular Carcinoma as limited. In Diabetes, the analyst points to the latest data showing Trulicity gaining market share on Novo Nordisk's (NVO) Victoza in the GLP-1 market.

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MYOV

Myovant Sciences

$12.39

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AVH

Avianca

$3.96

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SharpSpring

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CREG

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FENC

Fennec

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TD

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VIX

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$NSD

NASDAQ Market Internals

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$NYE

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RHE

Regional Health Properties

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TBIO

Translate Bio

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