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Johnson & Johnson (JNJ.N)

JNJ.N on New York Stock Exchange

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22 Nov 2017
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Latest Key Developments (Source: Significant Developments)

Janssen announces FDA approval of Juluca for the treatment of HIV-1 infection
Tuesday, 21 Nov 2017 06:06pm EST 

Nov 21 (Reuters) - ‍Janssen Therapeutics :Janssen announces U.S. FDA approval of first and only complete, single-pill, two-drug regimen, Juluca (dolutegravir and rilpivirine), for the treatment of HIV-1 infection.says U.S. FDA approval for single-pill, two-drug regimen, juluca for treatment of HIV-1 infection​.  Full Article

Janssen seeks expanded use of Darzalex from EMA
Tuesday, 21 Nov 2017 09:40am EST 

Nov 21 (Reuters) - Janssen-Cilag International NV::Says submission of type II variation application to European Medicines Agency, for immunotherapy Darzalex​​.  Full Article

Ionis eligible to get nearly $800 mln in milestones from deal with Janssen
Thursday, 16 Nov 2017 07:00am EST 

Nov 16 (Reuters) - Ionis Pharmaceuticals Inc -:Ionis Pharmaceuticals licenses second orally delivered antisense drug to Janssen.Ionis Pharmaceuticals - licensed second orally delivered generation 2.5 antisense drug to Janssen Biotech, Inc. for which Ionis earned $5 million​.Ionis Pharmaceuticals -Janssen to now assume all global development, regulatory, commercialization responsibilities for IONIS-JBI2-2.5(RX )for GI diseases​.Ionis Pharma- ‍under global collaboration deal with Janssen, co eligible to receive nearly $800 million in regulatory, sales milestone payments, others.Ionis Pharma- ‍in addition, will receive tiered royalties that on average are double-digits on sales from any product that is successfully commercialized​.Ionis Pharmaceuticals Inc - ‍IONIS-JBI1-2.5(RX), first collaboration target, was licensed to Janssen last year.  Full Article

Zymeworks announces license agreement with Johnson & Johnson Innovation
Monday, 13 Nov 2017 05:00am EST 

Nov 13 (Reuters) - Zymeworks Inc :Zymeworks announces license agreement with Johnson & Johnson Innovation to develop and commercialize next generation bispecific antibody therapeutics.Says ‍US$50 million upfront license fee paid to Zymeworks for up to six bispecific programs​.Says Zymeworks licenses azymetric and efect platforms to Janssen​.Says ‍deal was facilitated by Johnson & Johnson Innovation​.Says co is eligible to potentially receive up to $282 million in development & up to US$1.12 billion in commercial milestone payments, tiered royalties.Says ‍Janssen also has option to develop two additional bispecific programs under agreement subject to a future option payment​.  Full Article

Protagonist Therapeutics initiates phase 1 trial of oral peptide PTG-200
Thursday, 9 Nov 2017 08:00am EST 

Nov 9 (Reuters) - Protagonist Therapeutics Inc : :Protagonist Therapeutics initiates phase 1 trial of oral peptide IL-23 receptor antagonist, PTG-200.Protagonist Therapeutics - co is developing PTG-200 in collaboration with Janssen.  Full Article

J&J's Stelara shows positive results in treatment of systemic lupus erythematosus in phase 2 trial
Monday, 6 Nov 2017 08:00am EST 

Nov 6 (Reuters) - Johnson & Johnson ::Stelara® (ustekinumab) shows positive results in treatment of systemic lupus erythematosus in phase 2 trial.‍Janssen - positive results from randomized, placebo-controlled phase 2 study investigating anti-interleukin (il)-12/23 monoclonal antibody stelara​.‍P Janssen Research & Development says study met primary endpoint​.‍Janssen says plans to advance stelara into a phase 3 sle development program in 2018​.‍Janssen - stelara did not meet statistical significance in other secondary endpoints​.Janssen - ‍no deaths have been reported in study to date​.Janssen Research & Development says study met primary endpoint‍ (refiles to remove extraneous character)​.  Full Article

J&J says in Sept, co and Janssen were contacted by Texas and Colorado AG's offices
Thursday, 2 Nov 2017 04:33pm EDT 

Nov 2 (Reuters) - Johnson & Johnson :Johnson & Johnson - In September, co and Janssen Pharmaceuticals were contacted by the Texas and Colorado attorney general’s offices.Johnson & Johnson - co and Janssen Pharmaceuticals contacted on behalf of about 38 states regarding a multi-state attorney general investigation.Johnson & Johnson - The multi-state coalition served co and Janssen with subpoenas as part of the investigation related to opioids marketing practices.  Full Article

Halozyme - ‍Janssen Biotech initiated first phase 3 clinical trial evaluating subcutaneous delivery of Darzalex
Tuesday, 31 Oct 2017 08:30am EDT 

Oct 31 (Reuters) - Halozyme Therapeutics Inc :Halozyme - ‍Janssen Biotech initiated first phase 3 clinical trial evaluating subcutaneous delivery of Darzalex with co's enhanze technology​.Halozyme Therapeutics Inc - will receive a $15 million milestone payment from Janssen following dosing of third patient in a phase 3 trial​.  Full Article

Geron announces fast track designation grant for imetelstat
Tuesday, 31 Oct 2017 07:30am EDT 

Oct 31 (Reuters) - Geron Corp :Geron announces fast track designation granted to imetelstat for lower risk myelodysplastic syndromes.Geron Corp - FDA grants fast track designation for potential treatment of adult patients with transfusion-dependent anemia​.Geron- J‍anssen sponsored application for fast track designation using preliminary data from clinical trial being conducted by Janssen in lower risk MDS​.  Full Article

Johnson & Johnson says FDA approved 10 mg dose of Xarelto for reducing continued risk for recurrent venous thromboembolism​
Monday, 30 Oct 2017 08:00am EDT 

Oct 30 (Reuters) - Johnson & Johnson -:FDA approves new 10 mg dosing for Xarelto® (rivaroxaban) to reduce the continued risk of venous thromboembolism (VTE).Janssen Pharmaceuticals says U.S. FDA approved 10 mg once-daily dose of Xarelto for reducing continued risk for recurrent venous thromboembolism​.  Full Article

Johnson & Johnson drug succeeds in newly diagnosed multiple myeloma patients: study

Johnson & Johnson's blockbuster multiple myeloma drug Darzalex when added to a standard therapy regimen reduced the risk of disease progression or death by 50 percent compared with standard therapy alone in patients not previously treated for the blood cancer, according to data released on Tuesday.