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AGN

Allergan

$204.65

1.99 (0.98%)

16:57
09/22/17
09/22
16:57
09/22/17
16:57

Allergan receives refusal to file letter from FDA for Vraylar

Allergan announced that it received a refusal to file, or RTF letter from the FDA regarding its supplemental new drug application, or sDNA, for Vraylar for treatment of negative symptoms associated with schizophrenia in adult patients. Vraylar is an oral, once daily atypical antipsychotic approved in the U.S. for the treatment of schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder. Upon its preliminary review, the FDA determined that the sNDA for treatment of negative symptoms was not sufficiently complete to permit a substantive review. Cariprazine is approved in Europe for the treatment of schizophrenia. "We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our next steps. Vraylar is an important treatment option for patients suffering from bipolar I disorder and schizophrenia. We remain committed to our mental health program and to cariprazine and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia," said David Nicholson CRDO, Allergan.

  • 25

    Sep

AGN Allergan
$204.65

1.99 (0.98%)

09/20/17
SBSH
09/20/17
NO CHANGE
Target $280
SBSH
Buy
Allergan pipeline largely out of the shares, says Citi
Citi analyst Liav Abraham believes Allergan's pipeline remains largely out of the share price. In a research not titled "Emerging from the Twilight Zone. Reiterating Buy Rating," the analyst admits the outcome of the Restasis district court litigation remains a near-term overhang on the stock. She believes, however, that Allergan's pipeline will become a "more meaningful part of the debate heading into 2018." The company's nonalcoholic steatohepatitis opportunity, as well as its migraine assets, could generate $3B in peak non-risk-adjusted sales, which is largely not discounted in the current valuation, Abraham contends. She lowered her price target for Allergan shares to $280 from $290 and keeps a Buy rating on the name.
09/20/17
MSCO
09/20/17
DOWNGRADE
MSCO
Equal Weight
Allergan downgraded to Equal Weight from Overweight at Morgan Stanley
09/20/17
09/20/17
DOWNGRADE
Target $228

Equal Weight
Allergan cut to Equal Weight on lower margin assumptions at Morgan Stanley
As previously reported, Morgan Stanley analyst David Risinger downgraded Allergan to Equal Weight from Overweight, explaining that he previously projected growth above the average of its Major Pharma peers, but he now has less conviction in its pipeline catalysts, sees more Restasis patent risk and he no longer expects margin expansion because high gross margin products face generic pressures. The analyst lowered his longer-term margin assumptions for Allergan and cut his price target on the stock to $228 from $284.
09/22/17
WELS
09/22/17
NO CHANGE
Target $276
WELS
Outperform
Allergan trial not successful, but overhang removed, says Wells Fargo
Wells Fargo analyst David Maris says the best he can say about Allergan's data today for the treatment of liver fibrosis in adults with nonalcoholic steatohepatitis is that Cenicriviroc "seems safe and it may have a benefit in some patients." Overall, the study was not a success, but the good safety and other data support further study, Maris tells investors in a research note titled "Data Mixed, One Overhang Gone." The analyst keeps an Outperform rating on Allergan shares with a $276 price target.

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