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Theravance Biopharma Inc (TBPH.OQ)

TBPH.OQ on NASDAQ Stock Exchange Global Market

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21 Feb 2018
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Latest Key Developments (Source: Significant Developments)

Theravance Biopharma Ireland Enters Global Collaboration With Janssen
Wednesday, 7 Feb 2018 07:30am EST 

Feb 7 (Reuters) - Theravance Biopharma Ireland Limited::THERAVANCE BIOPHARMA IRELAND LTD - ENTERS GLOBAL COLLABORATION WITH JANSSEN FOR TD-1473 IN INFLAMMATORY INTESTINAL DISEASES.THERAVANCE BIOPHARMA - ELIGIBLE FOR UP TO $1 BILLION POTENTIAL PAYMENTS, INCLUDING $100 MILLION UPFRONT.THERAVANCE BIOPHARMA - PHASE 2B/3 STUDY IN ULCERATIVE COLITIS, PHASE 2 STUDY IN CROHN’S DISEASE TO BEGIN IN 2018 WITH TD-1473.THERAVANCE BIOPHARMA - WILL LEAD DEVELOPMENT OF TD-1473 IN ULCERATIVE COLITIS THROUGH COMPLETION OF PHASE 2B/3 PROGRAM.THERAVANCE BIOPHARMA - AFTER PHASE 2 CROHN’S STUDY, PHASE 2B INDUCTION PORTION OF ULCERATIVE COLITIS STUDY, JANSSEN CAN ENTER EXCLUSIVE LICENSE DEAL.THERAVANCE BIOPHARMA - AFTER PHASE 2, JANSSEN WOULD LEAD SUBSEQUENT DEVELOPMENT OF TD-1473 IN CROHN’S DISEASE.THERAVANCE BIOPHARMA - JANSSEN CAN ENTER EXCLUSIVE LICENSE DEAL FOR TD-1473 BY PAYING CO $200 MILLION FEE.THERAVANCE BIOPHARMA - IF TD-1473 COMMERCIALIZED, CO HAS OPTION TO CO-COMMERCIALIZE IN THE U.S..THERAVANCE BIOPHARMA - IF TD-1473 COMMERCIALIZED, JANSSEN WOULD HAVE SOLE COMMERCIALIZATION RESPONSIBILITIES OUTSIDE U.S..THERAVANCE BIOPHARMA - IF TD-1473 COMMERCIALIZED, CO ELIGIBLE FOR UP TO ADDITIONAL $700 MILLION DEVELOPMENT, COMMERCIALIZATION MILESTONE PAYMENTS.  Full Article

Theravance Biopharma ‍Files Supplemental NDA With U.S. FDA For Use Of Trelegy Ellipta​
Tuesday, 28 Nov 2017 07:00am EST 

Nov 28 (Reuters) - Theravance Biopharma Inc ::THERAVANCE BIOPHARMA HIGHLIGHTS SUBMISSION OF LANDMARK IMPACT DATA TO FDA TO SUPPORT EXPANDED LABEL FOR TRELEGY ELLIPTA.THERAVANCE BIOPHARMA INC - ‍FILED SUPPLEMENTAL NEW DRUG APPLICATION WITH U.S. FDA FOR USE OF TRELEGY ELLIPTA​.  Full Article

Theravance Biopharma and Mylan submit marketing application to FDA for revefenacin
Monday, 13 Nov 2017 09:28am EST 

Nov 13 (Reuters) - Theravance Biopharma Inc -:Theravance Biopharma and Mylan submit new drug application to FDA for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease.Theravance Biopharma Inc - ‍NDA is supported by companies' Phase 3 program for revefenacin​.  Full Article

Theravance Biopharma posts Q3 loss of $1.27 per share
Tuesday, 7 Nov 2017 04:02pm EST 

Nov 7 (Reuters) - Theravance Biopharma Inc :Theravance biopharma, inc. Reports third quarter 2017 financial results and provides business update.Q3 revenue $4.3 million versus i/b/e/s view $4.6 million.Cash, cash equivalents and marketable securities, excluding restricted cash, totaled $434.4 million as of september 30, 2017​.Qtrly basic and diluted net loss per share $1.27‍​.  Full Article

Theravance Biopharma and Mylan reports positive Phase 3 data for Revefenacin
Wednesday, 1 Nov 2017 08:30am EDT 

Nov 1 (Reuters) - Mylan Nv :Theravance Biopharma and mylan report additional positive phase 3 data for Revefenacin (TD-4208) in multiple presentations at 2017 Chest Annual Meeting.Theravance Biopharma Inc - ‍remain on track to submit an NDA for Revefenacin Q4 of 2017​.Theravance Biopharma Inc - ‍results demonstrated statistically significant and clinically meaningful improvements for revefenacin over placebo ​.Theravance Biopharma Inc - ‍both doses of revefenacin had comparable rates of adverse events to placebo​.  Full Article

Theravance Biopharma highlights positive results from impact study of Trelegy Ellipta
Wednesday, 20 Sep 2017 04:05pm EDT 

Sept 20 (Reuters) - Theravance Biopharma Inc :Theravance Biopharma highlights positive headline results from impact study of Trelegy Ellipta announced by Glaxosmithkline and Innoviva.Theravance Biopharma Inc - ‍Single inhaler triple therapy met study primary endpoint​.Theravance Biopharma Inc - Theravance Biopharma is entitled to receive an 85% economic interest in royalties paid by GSK on worldwide net sales.Theravance Biopharma Inc - Is not responsible for any costs related to Trelegy Ellipta.  Full Article

Theravance Biopharma highlights approval of trelegy ellipta for treatment of appropriate patients with COPD in the U.S.
Tuesday, 19 Sep 2017 08:30am EDT 

Sept 19 (Reuters) - Theravance Biopharma Inc :Theravance Biopharma highlights approval of trelegy ellipta (closed triple) as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US.Theravance Biopharma Inc - ‍Theravance Biopharma is entitled to receive an 85% economic interest in royalties paid by GSK on worldwide net sales​.Theravance Biopharma Inc - ‍Theravance Biopharma is not responsible for any costs related to trelegy ellipta​.  Full Article

Theravance Biopharma reports Q2 revenue of $3.5 mln
Tuesday, 8 Aug 2017 04:15pm EDT 

Aug 8 (Reuters) - Theravance Biopharma Inc :Reports second quarter 2017 financial results and provides business update.Q2 revenue $3.5 million.Q2 revenue view $4.7 million -- Thomson Reuters I/B/E/S.‍Revising guidance for operating loss excluding non-cash share-based compensation for FY 2017 to range of $205.0 million to $215.0 million​.  Full Article

Theravance Biopharma reports encouraging data from first cohort of patients in Phase 1b clinical trial of TD-1473 in ulcerative colitis
Tuesday, 8 Aug 2017 04:05pm EDT 

Aug 8 (Reuters) - Theravance Biopharma Inc :Theravance Biopharma Inc says plans to progress TD-1473 into induction and maintenance study in 2018.Theravance Biopharma Inc says in first cohort, there were no moderate or serious adverse events related to TD-1473.  Full Article

Theravance Biopharma announces positive top-line results from phase 2B study of velusetrag
Wednesday, 2 Aug 2017 07:00am EDT 

Aug 2 (Reuters) - Theravance Biopharma Inc :Theravance Biopharma announces positive top-line results from phase 2B study of Velusetrag (TD-5108) in patients with gastroparesis.Theravance Biopharma - top-line results demonstrated statistically significant improvements in gastroparesis symptoms and gastric emptying in patients.Theravance Biopharma - patients were receiving 5 mg of Velusetrag as compared to placebo.Theravance Biopharma - additionally, Velusetrag was shown to be generally well-tolerated.  Full Article

BRIEF-Theravance Biopharma And Mylan Announce FDA Acceptance Of New Drug Application For Revefenacin

* THERAVANCE BIOPHARMA AND MYLAN ANNOUNCE FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR REVEFENACIN (TD-4208) IN ADULTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE