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Stock Market & Financial Investment News

News Breaks
August 21, 2014
07:38 EDTSUPN, ACTSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
Supernus Pharmaceuticals (SUPN) announced that on August 20, the company received a Paragraph IV Notice Letter from Actavis Laboratories FL advising Supernus of the filing by Actavis (ACT) of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules. Supernus is currently reviewing the details of this Notice Letter and intends to vigorously enforce its intellectual property rights relating to Trokendi XR. The product is currently protected by three issued patents that are listed in the FDA's Orange Book and expire no earlier than 2027.
News For SUPN;ACT From The Last 14 Days
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March 4, 2015
17:50 EDTACTActavis confirms District Court ruling that Atelvia patents are invalid
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March 2, 2015
08:31 EDTACTActavis receives approval from Europcean Commission for Xydalba
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February 27, 2015
08:04 EDTACTActavis and Medicines360 announce FDA approval of LILETTA
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08:02 EDTACTFDA PDUFA Date for Actavis Nebivolol/Valsartan is February 27, 2015
February 25, 2015
17:26 EDTACTActavis' Avycaz for infections approved by FDA
Actavis' Avycaz has been approved by the FDA for the treatment of adult patients with complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. AVYCAZ received a priority review based on Phase II data from the company's clinical development program and supporting in vitro data, and as such should be reserved for use in patients who have limited or no alternative treatment options. AVYCAZ will be available in Q2.
08:19 EDTACTActavis price target raised to $350 from $315 at Bernstein
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07:59 EDTACTActavis 13.2M share Secondary priced at $288.00
The deal size was lowered to $3.8B from $4.2B and but the convertible preferred was up-sized to $4.6B from $4.2B. JPMorgan, Mizuho, Wells Fargo and Morgan Stanley acted as joint book running managers for the offering.
February 24, 2015
16:27 EDTACTActavis confirms generic Uceris patent challenge
Actavis (ACT) confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Budesonide Extended-release Tablets, 9 mg. Actavis' ANDA product is a generic version of Salix Pharmaceuticals' (SLXP) Uceris, which is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
February 23, 2015
12:53 EDTACTAnalysts debate potential for competing Salix takeover bid
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February 20, 2015
08:46 EDTACTActavis receives final approval for generic version of Subutex
Actavis announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex. Actavis intends to begin shipping its product shortly. Subutex is indicated for the treatment of opioid dependence. For the 12 months ending December 31, 2014, Subutex had total U.S. sales of approximately $108M, according to IMS Health data.
08:07 EDTACTActavis price target raised to $340 from $310 at Argus
Argus increased its price target on Actavis as the firm believes that the company is generating strong growth. Argus is upbeat on the company's acquisition of Allergan and keeps a Buy rating on the shares.

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