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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)

Shire's angioedema drug succeeds in late-stage study
Thursday, 18 May 2017 07:00am EDT 

May 18 (Reuters) - Shire Plc :Shire's investigational treatment lanadelumab reduces hereditary angioedema monthly attack rate by 87% versus placebo in phase 3 26-week pivotal trial.Says data to serve as basis for U.S. BLA filing expected in Q4 2017 to Q1 2018.Shire - study met its primary endpoint and all secondary endpoints with highly statistically significant, clinically meaningful results for all three lanadelumab treatment arms.Shire Plc - lanadelumab was generally well tolerated over 26-week treatment period.Says no treatment-related serious adverse events or deaths were reported.Shire Plc - plans to submit a biologics license application (BLA) for evaluation by U.S. Food and Drug Administration (FDA) by late 2017 or early 2018.  Full Article

Shire and Parion Sciences enter into a collaborative license agreement
Monday, 1 May 2017 07:00am EDT 

May 1 (Reuters) - Shire Plc ::Shire and Parion Sciences enter into a collaborative license agreement to advance p-321 for ophthalmic indications.Demonstrates ongoing commitment to innovation in ophthalmics for Shire.Shire Plc will make initial $20 million upfront license payment with an additional $20 million payment based on milestone.Parion will be entitled to receive additional potential milestone payments, with a total potential deal value of up to $535 million.Parion has option to co-fund through additional stages of development in exchange for enhanced tiered double-digit royalties..Parion also has option to co-fund commercialization activities and participate in financial outcome from those activities..  Full Article

Shire says ADHD treatment Intuniv receives approval in Japan
Thursday, 30 Mar 2017 04:42am EDT 

Shire Plc :Intuniv (guanfacine hydrochloride prolonged release), a non-stimulant for the treatment of ADHD, receives approval in Japan.  Full Article

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

More From Around the Web

BRIEF-Xenetic Biosciences receives update from Shire's Phase 1/2 study evaluating SHP656 in development as long-acting treatment for Hemophilia A

* Xenetic Biosciences - receives program update from partner Shire's phase 1/2 study evaluating SHP656 in development as a long-acting treatment for Hemophilia A