Key Developments: Actavis PLC (ACT)

ACT on New York Consolidated

226.57USD
28 Aug 2014
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$-0.02 (-0.01%)
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Latest Key Developments (Source: Significant Developments)

Actavis plc announces FDA acceptance for filing of NDA for Eluxadoline
9:20am EDT 

Actavis plc:Says U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome.Actavis' NDA for eluxadoline has been granted priority review status by the FDA.  Full Article

Actavis plc confirms generic neupro patent challenge
Friday, 22 Aug 2014 04:05pm EDT 

Actavis plc:Confirms that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr.Actavis' ANDA product is a generic version of UCB's Neupro, which is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS).  Full Article

Actavis plc announces positive topline results fro phase III program of ceftazidime-avibactam in patients with Complicated Intra-Abdominal Infections(cIAI)
Tuesday, 19 Aug 2014 07:30am EDT 

Actavis plc:Confirmed positive topline results from RECLAIM-1 and -2, pivotal Phase III studies evaluating the potential for the investigational antibiotic, ceftazidime-avibactam as a treatment for adult hospitalized patients with complicated intra-abdominal infections.Ceftazidime-avibactam consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor (avibactam).Compound is being developed to treat a broad range of Gram-negative bacterial infections, which are becoming resistant to antibiotics and pose an increasing threat to public health.Says global RECLAIM-1 and RECLAIM-2 Phase III studies both evaluated safety and efficacy of ceftazidime-avibactam, administered intravenously as two hour infusion (2000 mg / 500 mg).Saysp lus metronidazole, compared to meropenem, administered intravenously as a 30-minute infusion (1 g), in hospitalized adult patients with complicated intra-abdominal infections.Data from the RECLAIM-1 and RECLAIM-2 studies were analyzed as a single-pooled dataset with the agreement of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).  Full Article

Actavis plc gives H2 2014 guidance; earnings guidance below analysts' estimates; gives FY 2014 EPS guidance below analysts' estimates; gives FY 2015 guidance; revenue guidance above estimates
Tuesday, 5 Aug 2014 07:00am EDT 

Actavis plc:Estimates H2 2014 total net revenue to be about $7 bln.Expects H2 2014 adjusted EBITDA to be between $2.509 bln and $2.584 bln.Expects H2 2014 non-GAAP earnings to be between $6.25 and $6.50 per diluted share (EPS).Expects FY 2014 earnings per share of between $13.02 and $13.32.Estimates FY 2015 Net revenue to be about $15 bln.Expects FY 2015 adjusted EBITDA to be between $5.958 bln and $6.364 bln.Expects FY 2015 non-GAAP earnings per diluted share to be between $15.60 and $16.80.Q3 2014 revenue of $3.598 bln, EBITDA of $1.278 bln and EPS of $3.27 - Thomson Reuters I/B/E/S.Q4 2014 revenue of $3.695 bln, EBITDA of $1.379 bln and EPS of $3.70 - Thomson Reuters I/B/E/S.FY 2014 EPS of $13.73 - Thomson Reuters I/B/E/S.FY 2015 revenue of $15.59 bln, EBITDA of $6.173 bln and EPS of $16.61 - Thomson Reuters I/B/E/S.  Full Article

Medicines360 and Actavis plc announces FDA acceptance for filing of NDA for Levosert IUD
Monday, 21 Jul 2014 04:30pm EDT 

Medicines360 and Actavis plc:Says that U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's New Drug Application (NDA) for Levosert (levonorgestrel), hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy.  Full Article

Actavis plc confirms generic Diclegis patent challenge
Friday, 11 Jul 2014 04:25pm EDT 

Actavis plc:Confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release tablets, 10 mg/10 mg.ANDA product is a generic version of Duchesnay Inc.'s Diclegis, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.  Full Article

Impax Laboratories acquires two products from Actavis
Wednesday, 2 Jul 2014 04:05pm EDT 

Impax Laboratories Inc:Acquires from Actavis plc two generic products for cash consideration pursuant to a purchase agreement and a supply agreement.Financial terms of the agreement were not disclosed.  Full Article

Actavis plc completes acquisition of Furiex Pharmaceuticals Inc
Wednesday, 2 Jul 2014 08:46am EDT 

Actavis plc:Completes acquisition of Furiex Pharmaceuticals, Inc. in all-cash transaction valued at about $1.1 bln, and up to about $360 mln in Contingent Value Right that may be payable based on status of eluxadoline, Furiex's lead product, as controlled drug following approval.Says in connection with close of Furiex acquisition, Actavis further announced that it has closed the transaction related to the sale of Furiex's royalties on alogliptin and Priligy to Royalty Pharma for about $415 mln.  Full Article

Actavis plc appoints CEO and President
Tuesday, 1 Jul 2014 09:00am EDT 

Actavis plc:Appointed Brenton L. Saunders as CEO and President.  Full Article

Actavis plc completes Forest Laboratories acquisition
Tuesday, 1 Jul 2014 08:20am EDT 

Actavis plc:Completed acquisition of Forest Laboratories, Inc. in cash and equity transaction currently valued at about $28 bln.Combination creates one of specialty pharmaceutical companies, with annual revenues of more than $15 bln anticipated for 2015.  Full Article

Drugmaker Actavis forecasts profit below estimates

- Generic drug maker Actavis Plc's full-year profit forecast missed analysts' estimates, sending its shares down about 3 percent in premarket trading.

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