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June 26, 2014
08:42 EDTMNK, IGMallinckrodt grants IGI Labs non-exclusive license to launch generic PENNSAID
IGI Laboratories (IG) announced that it has entered into an agreement with Mallinckrodt (MNK) and Nuvo Research to settle a declaratory judgment action brought by IGI, concerning IGI's filing of an abbreviated new drug application with the FDA seeking approval to market a generic version of PENNSAID 1.5% w/w. Under the terms of this agreement, Mallinckrodt granted IGI a non-exclusive license to launch its diclofenac sodium topical solution 1.5% product on March 28, 2015. IGI received tentative approval of its diclofenac sodium topical solution 1.5% from the FDA on May 7. IGI CEO Jason Grenfell-Gardner said, "The agreement provides IGI with a date certain launch of diclofenac sodium topical solution 1.5%. We remain confident in our ability to obtain final FDA approval of our ANDA for diclofenac sodium topical solution 1.5% prior to our agreed upon launch date. The agreement allows IGI to continue to expand its portfolio of generic topical prescription drug products."
News For IG;MNK From The Last 14 Days
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October 6, 2015
07:43 EDTMNKMallinckrodt wants no more than a third of operating income from single product
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07:42 EDTMNKMallinckrodt says specialty generics business will have difficult comparisons
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07:41 EDTMNKMallinckrodt says Acthar is 'complex product', expects long-term volume growth
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06:54 EDTMNKMallinckrodt to hold a conference call
Management holds a business update conference call on October 6 at 7:30 am. Webcast Link
06:10 EDTMNKMallinckrodt sees FY16 net sales from Specialty Brands up at least 30%
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06:06 EDTMNKMallinckrodt sees FY16 adjusted EPS $7.70-$8.20, consensus $8.00
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October 5, 2015
18:56 EDTMNKOn The Fly: After Hours Movers
HIGHER: Regulus Therapeutics (RGLS), up 8.7% after the company announced that it will present new preclinical data on RG-012 for kidney disease... Palatin Technologies (PTN), up 9.6% after director Robert deVeer Jr. buys 10,000 shares of common stock... Arena Pharmaceuticals (ARNA), up 4.7% after CEO Jack Lief announced his retirement and Harry Hixson was named interim CEO... DuPont (DD), up 5.9% after CEO and chair Ellen Kullman retires... Ruckus Wireless (RKUS), up 4.9% after joining the S&P 600... Starz (STRZA), up 10.1% after the LA Times reports that Lionsgate (LGF) is in advanced talks to merge with Starz. DOWN AFTER EARNINGS: Container Store (TCS), down 10.4%. ALSO LOWER: Sarepta Therapeutics (SRPT), down 3.8% after filing to sell $125M of common stock... Haemonetics (HAE), down 12.2% after lowering its fiscal 2016 outlook... Energy XXI (EXXI), down 8.3% after filing a $500M mixed securities shelf... Mallinckrodt (MNK), down 1.6% after announcing that it will provide a business update and financial guidance for the fiscal year ending September 30, 2016, on an investor call on October 6.
17:58 EDTMNKMallinckrodt down 1.9% after announcing business update conference call
Mallinckrodt announced that it will provide a business update and financial guidance for the fiscal year ending September 30, 2016, on an investor call on October 6, 2015. Mallinckrodt will also provide recast historical financial information reflecting the reclassification of its CMDS business to discontinued operations. The company announced plans to sell its CMDS business to Guerbet in late July 2015, with a closing expected in Q1 of FY16.
15:04 EDTMNKMallinckrodt management to meet with JPMorgan
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09:25 EDTIGIGI Laboratories acquires three commercialized injectable products for $10M cash
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08:03 EDTIGIGI Laboratories appoints Stephen Richardson as Chief Scientific Officer
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October 2, 2015
08:00 EDTIGIGI Laboratories submits ninth ANDA to FDA of 2015
IGI Laboratories announced it has submitted its ninth abbreviated new drug application to the FDA of 2015, which brings the company's total number of ANDA submissions now pending at the FDA to thirty-one.
September 29, 2015
10:00 EDTMNKOn The Fly: Analyst Initiation Summary
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08:18 EDTMNKMallinckrodt initiated with a Neutral at Nomura
Target $100.
September 25, 2015
07:23 EDTMNKMallinckrodt estimates lowered due to Acthar competition at UBS
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September 24, 2015
09:21 EDTIGIGI Laboratories management to meet with Oppenheimer
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05:52 EDTMNKBarclays says 'hard to imagine' Mallinckrodt sentiment getting worse
It's "hard to imagine" investor sentiment for Mallinckrodt (MNK) getting worse, especially relating to Acthar, Barclays analyst Douglas Tsao tells investors in a research note. Disappointing Acthar sales coupled with competitive concerns following ANI Pharmaceuticals' (ANIP) purchase Monday of two new drug applications for purified corticotropin gel and corticotropin-zinc hydroxide have hurt sentiment, Tsao writes. He cut his price target for Mallinckrodt shares to $100 from $135 but keeps an Overweight rating on the name. After speaking with two rheumatologists, the analyst is "incrementally confident" in Mallinckrodt's ability to grow Acthar sales, especially as a potential treatment in lupus. He sees the stock bouncing higher from current levels. Mallinckrodt closed yesterday down $1.26 to $71.64.
September 23, 2015
08:10 EDTMNKMallinckrodt says USPTO grants requests for trial by Praxair
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September 22, 2015
08:03 EDTIGIGI Laboratories announces eighth ANDA submitted to FDA of 2015
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07:43 EDTMNKDrug stocks could be hurt by focus on pricing, says Oppenheimer
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