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NVO

Novo Nordisk

$40.73

-0.13 (-0.32%)

17:58
10/07/16
10/07
17:58
10/07/16
17:58

Novo Nordisk receives CRL from FDA for faster-acting insulin aspart

Novo Nordisk announced that it has received a Complete Response Letter from the US Food and Drug Administration regarding the New Drug Application for faster-acting insulin aspart. In the letter, the FDA requests additional information related to the assay for the immunogenicity and clinical pharmacology data before the review of the New Drug Application can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to resolve the outstanding issues. "We believe faster-acting insulin aspart can address an unmet medical need for people requiring improved blood glucose control around meals, and our ambitions for this innovative drug are unchanged", says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We acknowledge the request for information from FDA and will work closely with the agency to determine the best path forward to complete the review." The New Drug Application for faster-acting insulin aspart was submitted to the FDA in December 2015. Faster acting insulin aspart is currently also under review in the EU, Switzerland, Canada, Brazil, South Africa and Argentina.

  • 06

    Nov

NVO Novo Nordisk
$40.73

-0.13 (-0.32%)

09/09/16
JPMS
09/09/16
DOWNGRADE
JPMS
Neutral
Novo Nordisk downgraded to Neutral from Overweight at JPMorgan
JPMorgan analyst Richard Vosser downgraded Novo Nordisk to Neutral saying additional upside is "hard to justify" given the more hostile U.S. pricing environment. The analyst sees a balanced risk/reward at current share levels.
09/12/16
DBAB
09/12/16
UPGRADE
DBAB
Buy
Novo Nordisk upgraded to Buy from Hold at Deutsche Bank
Deutsche Bank analyst Tim Race upgraded Novo Nordisk to Buy saying the company's long-term prospects in diabetes are positive. Insulin price concerns in the U.S. are well known and reflected by the company's 24% share price decline year-to-date, Race tells investors in a research note. He has a DKK 360 price target for the shares.
09/13/16
EXAN
09/13/16
UPGRADE
EXAN
Outperform
Novo Nordisk upgraded to Outperform from Neutral at Exane BNP Paribas
09/23/16
PIPR
09/23/16
INITIATION
PIPR
Neutral
Novo Nordisk initiated with a Neutral at Piper Jaffray
Piper Jaffray analyst Richard Purkiss started Novo Nordisk with a Neutral rating and DKK 320 price target.

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