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Shire PLC (SHPG.OQ)

SHPG.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

FDA grants fast track designation for Shire's Recombinant Adamts13
Wednesday, 22 Mar 2017 07:08am EDT 

Shire Plc - : Shire Plc - United States Food And Drug Administration (FDA) has granted fast track designation for Recombinant Adamts13 .Will initiate its phase 3 trial with SHP655 as a randomized, open-label, 2-period crossover study with a single arm continuation.  Full Article

FDA grants fast track designation for Shire's Recombinant ADAMTS13
Wednesday, 22 Mar 2017 07:00am EDT 

Shire Plc :Shire receives FDA fast track designation for Recombinant ADAMTS13 (SHP655) for treatment of hereditary thrombotic thrombocytopenic purpura.  Full Article

Neos Therapeutics enters into a license agreement with Shire
Friday, 10 Mar 2017 04:09pm EST 

Neos Therapeutics Inc : On March 6, 2017, Neos Therapeutics entered into a license agreement with Shire - SEC filing . Pursuant to deal Shire granted to Co non-exclusive license to certain patents owned by Shire for activities with respect to NT-0201 . Company will also pay a single digit royalty on net sales of NT-0201 during life of Shire patents . Agreement contains covenant from Shire not to file a patent infringement suit against Co alleging NT-0201 would infringe Shire patents .Under terms of license agreement, Co is required to pay lump sum, license fee of less than $1.0 million.  Full Article

EU regulator recommends condition approval of Shire's chronic hypoparathyroidism medicine
Friday, 24 Feb 2017 07:00am EST 

EU Medicines Agency: Recommendations for February 2017 . Recommends conditional marketing authorisation of Shire's orphan medicine Natpar for chronic hypoparathyroidism . Recommends approval of Astrazeneca's ZS-9 (sodium zirconium cyclosilicate) for high potassium levels . Recommends approval of Tesaro Inc's rolapitant, against chemotherapy-induced nausea and vomiting . Recommends approval of Gilead's Descovy for the treatment of HIV Link to press release: (http://bit.ly/2lCHPks) Further company coverage: [AZN.L][SHP.L][GILD.O][TSRO.O] (Bengaluru Newsroom: +91 806 749 1136).  Full Article

Shire reports positive results in phase 1b study of skin swelling drug Lanadelumab
Thursday, 23 Feb 2017 04:11am EST 

Shire Plc : Results served as basis for ongoing phase 3 trial . No serious adverse events or discontinuations due to adverse events were observed at all doses studied . Pre-Specified efficacy analyses in patients with at least 2 attacks in 3 months showed reduced rate of attacks by between 88-100 percent for dosage range versus placebo .All subjects were attack-free in 300 mg group and 82 pct were attack-free in 400 mg group versus 27 pct in placebo group.  Full Article

Third Point LLC takes share stake in JPMorgan, Bank of America - SEC Filing
Friday, 10 Feb 2017 04:44pm EST 

Third Point Llc : Third Point Llc dissolves share stake in Allergan Plc - SEC Filing . Third Point Llc takes share stake of 1.0 million shares in Anthem Inc . Third Point Llc takes share stake of 3.0 million shares in Conagra Brands Inc . Third Point Llc takes share stake of 1.4 million shares in Honeywell International Inc . Third Point Llc takes share stake of 17.5 million shares in Bank of America . Third Point Llc dissolves share stake in Liberty Global Plc . Third Point Llc dissolves share stake in Shire Plc . Third Point Llc takes share stake of 5.3 million shares in JPMorgan Chase & Co .Third Point Llc - change in holdings are as of Dec 31, 2016 and compared with the previous quarter ended as of Sept 30, 2016.  Full Article

Shire Plc responds to U.S. Federal Trade Commission civil action
Tuesday, 7 Feb 2017 03:42pm EST 

Shire Plc : Shire plc says responds to u.s. Federal trade commission civil action . Shire plc -acknowledges decision by u.s. Federal trade commission to file a civil action against one of its subsidiaries, shire viropharma . Shire plc -decision by u.s. Ftc related to citizen petition submissions viropharma filed regarding one of its products, vancocin .Shire plc says "company played no role in viropharma's challenged petitioning, which took place between 2006 and 2012".  Full Article

U.S FDA acknowledges receipt of Shire's ADHD drug application
Thursday, 19 Jan 2017 07:04am EST 

Shire Plc : U.S. FDA acknowledges receipt of Shire's new drug application for SHP465 for ADHD . fda has acknowledged receipt of class 2 resubmission of a new drug application (nda) for shp465, a long-acting, triple-bead, mixed amphetamine salts formulation . Shp465 is being evaluated as a potential once-daily treatment for attention-deficit/hyperactivity disorder . FDA is expected to provide a decision on or around june 20, 2017, designated prescription drug user fee act (PDUFA) action date .Protection for shire's ADHD franchise extends to 2029.  Full Article

Momenta provides year-end 2016 corporate update
Friday, 6 Jan 2017 08:00am EST 

Momenta Pharmaceuticals Inc : Momenta provides year-end 2016 corporate update . Momenta Pharmaceuticals Inc - reiterated its non-gaap operating expense guidance of approximately $40 - $45 million for Q4 of 2016 . Momenta Pharmaceuticals Inc - expects to report approximately $350.0 million of cash, cash equivalents and marketable securities at December 31, 2016 .Momenta Pharmaceuticals Inc - currently assessing U.S. Gaap accounting treatment for shire and csl agreements.  Full Article

RaNa acquires Shire's industry leading messenger RNA platform
Wednesday, 4 Jan 2017 07:30am EST 

Shire Plc : RaNa acquires Shire's industry leading messenger RNA platform . RaNa Therapeutics announces acquisition of MRT platform, an MRNA therapy platform, developed by subsidiaries of Shire .RaNa Therapeutics says Shire to receive equity stake in RaNa and is eligible for future milestones and royalties on products developed with technology.  Full Article

More From Around the Web

Patent trial begins in Shire bid to block generic Adderall XR

Shire PLC's bid to prevent a Florida-based drug company from being able to go to market with a generic version of extended-release Adderall entered the courtroom phase on Monday as a bench trial began.