Edition:
United States

Allergan plc (AGN)

AGN on New York Consolidated

204.65USD
22 Sep 2017
Change (% chg)

$1.99 (+0.98%)
Prev Close
$202.66
Open
$202.50
Day's High
$209.25
Day's Low
$201.42
Volume
3,903,818
Avg. Vol
2,245,197
52-wk High
$256.80
52-wk Low
$184.50

Latest Key Developments (Source: Significant Developments)

Allergan receives refusal to file letter from FDA for Vraylar SNDA
Friday, 22 Sep 2017 04:50pm EDT 

Sept 22 (Reuters) - Allergan Plc :Allergan receives refusal to file letter from FDA for Vraylar (Cariprazine) supplemental new drug application (SNDA) for the treatment of negative symptoms in Schizophrenia.Allergan receives refusal to file letter from FDA for Vraylar (Cariprazine) supplemental new drug application (SNDA) for the treatment of negative symptoms in Schizophrenia.Allergan-‍upon its preliminary review, FDA determined SNDA for treatment of negative symptoms was not sufficiently complete to permit substantive review​.Allergan PLC - ‍Company will seek immediate guidance, and is in process of planning a meeting with FDA​.  Full Article

Allergan Plc says new data from phase 2b study supports continued development of cenicriviroc in ongoing phase 3 trial
Friday, 22 Sep 2017 08:00am EDT 

Sept 22 (Reuters) - Allergan Plc :New data from CENTAUR phase 2b clinical study supports continued development of cenicriviroc (CVC) in ongoing phase 3 AURORA trial.Allergan Plc - ‍in placebo patients who crossed over to receive CVC during year two, 20% of patients receiving CVC compared to 13% of patients receiving placebo achieved combined endpoint​.Allergan Plc - ‍new data includes patients who remained on treatment for 2 years, those who received placebo in year 1, crossed-over to CVC for year​ 2.Allergan - ‍in patients treated for two years, no significant difference in fibrosis improvement observed between CVC, placebo at year 2 in CENTAUR study​.  Full Article

Imprimis Pharmaceuticals ‍responded to Allergan Plc press release regarding lawsuit
Monday, 11 Sep 2017 07:30am EDT 

Sept 11 (Reuters) - Allergan Plc :Imprimis Pharmaceuticals Inc - ‍responded to a press release issued by Allergan Plc regarding a lawsuit Allergan USA, Inc. filed against Imprimis​.Imprimis Pharmaceuticals Inc says will defend itself against Allergan's lawsuit​.  Full Article

Allergan and Saint Regis Mohawk Tribe announce agreements regarding RESTASIS patents
Friday, 8 Sep 2017 12:34pm EDT 

Sept 8 (Reuters) - Allergan Plc :Allergan and Saint Regis Mohawk Tribe announce agreements regarding restasis® patents.Says ‍under terms of agreement, Tribe will receive $13.75 million upon execution of agreement​.Says ‍tribe will be eligible to receive $15 million in annual royalties​.Says ‍tribe is filing motion to dismiss ongoing inter partes review of restasis patents based on "their sovereign immunity from ipr challenges"​.Says ‍agreement with tribe has no impact on pending anda patent litigations regarding restasis patent family which completed 5-day trial in court.Says ‍CO, Saint Regis Mohawk tribe announced tribe now owns all orange book-listed patents for restasis (cyclosporine ophthalmic emulsion) 0.05%​.Says Allergan has been granted exclusive licenses in patents related to product​.  Full Article

Allergan USA files suits against Imprimis, Prescriber's Choice and Sincerus Florida
Thursday, 7 Sep 2017 08:53pm EDT 

Sept 7 (Reuters) - Allergan Plc :Allergan files suits against Imprimis Pharmaceuticals, Inc., Prescriber's Choice, Inc., and Sincerus Florida, LLC.Says Allergan USA filed lawsuits against Imprimis Pharmaceuticals, Prescriber's Choice, and Sincerus Florida.Allergan USA's lawsuit alleges that the companies are unlawfully manufacturing and selling unapproved new drugs.Lawsuit alleges that the co's are violating lanham act and state law by false and misleading advertising, promotion of unapproved new drugs.  Full Article

Allergan settles Restasisn 0.05% patent litigation with Famy Care
Monday, 28 Aug 2017 04:15pm EDT 

Aug 28 (Reuters) - Allergan Plc :Allergan announces settlement of Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% patent litigation with Famy Care.Allergan PLC - ‍Agreement provides dismissal of litigation and termination of pending IPR petitions​.Allergan PLC says additional details regarding settlement were not disclosed.Allergan PLC - ‍As a result of settlement, all Famy Care litigation regarding Restasis patents will be dismissed​.Allergan PLC - ‍As a result of settlement, Famy Care will terminate its pending petitions for inter parties review​.Allergan - Co will grant Famy Care license to market generic version of Restasis in U.S. beginning Feb 27, 2024, or earlier under some circumstances​.  Full Article

Allergan says as part of internal optimization restructuring programs, co intends to eliminate about 400 positions - SEC Filing‍​
Wednesday, 9 Aug 2017 07:54am EDT 

Aug 9 (Reuters) - Allergan Plc :Allergan Plc - As part of internal optimization restructuring programs, co intends to eliminate about 400 positions - Sec Filing‍​.Allergan Plc - During the three months ended June 30, 2017, co recognized restructuring charges of $119.0 million.Allergan Plc - Restructuring charges for Q2 includee costs related to planned internal reduction of about 200 positions within research and development organization.  Full Article

FDA approves Medicines360's SNDA for Liletta to prevent pregnancy for up to four years
Monday, 7 Aug 2017 08:00am EDT 

Aug 7 (Reuters) - Allergan Plc :FDA approves Medicines360's SNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to four years.Allergan Plc - ‍FDA approved Medicines360's SNDA to extend duration of use of Liletta 52 mg for prevention of pregnancy for up to four years​.  Full Article

Allergan Plc Q2 revenue $4.0 billion
Thursday, 3 Aug 2017 07:52am EDT 

Aug 3 (Reuters) - Allergan Plc :Allergan reports continued strong execution in second quarter 2017 with 9% increase in GAAP net revenues to $4.0 billion.Q2 revenue $4.0 billion versus I/B/E/S view $3.94 billion.‍Q2 2017 GAAP continuing operations loss per share of $2.35​.Q2 non-GAAP performance net income per share of $4.02​.Company raises full-year 2017 continuing operations guidance​.Company recorded restructuring charges of $65.6 million in q2 of 2017​.Sees full year 2017 GAAP loss per share $10.80 - $11.20​.Sees total net revenues in FY 2017 of $15,850 million - $16,050 million.Sees FY non GAAP earnings per share ‍$16.05 - $16.45​.FY2017 earnings per share view $16.08, revenue view $15.80 billion -- Thomson Reuters I/B/E/S.Q2 earnings per share view $3.92 -- Thomson Reuters I/B/E/S.  Full Article

Allergan Q3 cash dividend of $0.70/shr
Wednesday, 2 Aug 2017 08:00am EDT 

Aug 2 (Reuters) - Allergan Plc :Allergan announces third quarter 2017 cash dividend of $0.70 per ordinary share.  Full Article

BRIEF-Allergan receives refusal to file letter from FDA for Vraylar SNDA

* Allergan receives refusal to file letter from FDA for Vraylar (Cariprazine) supplemental new drug application (SNDA) for the treatment of negative symptoms in Schizophrenia