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Bioverativ Inc (BIVV.OQ)

BIVV.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Bioverativ’s BIVV009 achieves positive results in Phase 1B CAgD patients
Monday, 11 Dec 2017 02:47pm EST 

Dec 11 (Reuters) - Bioverativ Inc ::BIOVERATIV’S INVESTIGATIONAL BIVV009 DEMONSTRATES SAFETY, TOLERABILITY AND EFFICACY IN PHASE 1B CLINICAL TRIAL IN COLD AGGLUTININ DISEASE (CAGD) PATIENTS.BIOVERATIV INC - PHASE 1B RESULTS ACHIEVE PRIMARY AND SECONDARY ENDPOINTS IN CAGD COHORT.BIOVERATIV - FOUND STATISTICALLY SIGNIFICANT OVERALL INCREASED RATE OF THROMBOEMBOLIC EVENTS IN CAGD PATIENTS VERSUS MATCHED CONTROLS.  Full Article

Bioverativ says U.S. ‍FDA Has Approved Updated Labeling For Alprolix ​
Monday, 27 Nov 2017 07:30am EST 

Nov 27 (Reuters) - Bioverativ Inc ::BIOVERATIV INC - U.S. ‍FDA HAS APPROVED UPDATED LABELING FOR ALPROLIX ​.BIOVERATIV INC SAYS LABEL UPDATE INCLUDES ADDITION OF PEDIATRIC DATA RELATED TO PROPHYLACTIC TREATMENT WITH ALPROLIX.  Full Article

Bioverativ reports Q3 earnings per share $0.63
Thursday, 26 Oct 2017 04:15pm EDT 

Oct 26 (Reuters) - Bioverativ Inc :Bioverativ reports third quarter 2017 performance.Q3 non-gaap earnings per share $0.80.Q3 gaap earnings per share $0.63.Q3 revenue $291.6 million versus i/b/e/s view $285.5 million.Q3 earnings per share view $0.69 -- Thomson Reuters I/B/E/S.  Full Article

Sangamo and Bioverativ announce FDA acceptance of IND application for ST-400
Monday, 2 Oct 2017 07:30am EDT 

Oct 2 (Reuters) - Bioverativ Inc :Sangamo and Bioverativ announce FDA acceptance of IND application for ST-400 -- a gene-edited cell therapy candidate -- to treat beta-thalassemia.Sangamo Therapeutics Inc - ‍expects to open several clinical sites across United States and begin enrolling patients in first half of 2018​.Sangamo Therapeutics - based on deal terms, Sangamo responsible for conducting ST-400 phase 1/2 clinical trial.Sangamo Therapeutics - based on deal terms, Bioverativ responsible for subsequent worldwide clinical development, manufacturing, commercialization.  Full Article

Bioverativ and Bicycle Therapeutics enter into strategic research collaboration
Wednesday, 6 Sep 2017 02:51am EDT 

Sept 6 (Reuters) - Bioverativ Inc -:Bioverativ and Bicycle Therapeutics enter into strategic research collaboration to develop therapies for haemophilia and sickle cell disease.Says Bicycle to receive an upfront payment of $10 million, with potential for future milestones.Bioverativ Inc - upon execution of agreement, Bicycle will receive near-term research and development funding of $4.2 million.Bioverativ Inc - Bicycle is eligible to receive up to $410 million related to development, regulatory ,commercialisation milestones.Says additional terms of transaction are not being disclosed.  Full Article

Bioverativ reports Q2 GAAP earnings per share $0.71
Wednesday, 2 Aug 2017 04:31pm EDT 

Aug 2 (Reuters) - Bioverativ Inc :Bioverativ reports second quarter 2017 performance.Q2 non-gaap earnings per share $0.88.Q2 gaap earnings per share $0.71.Q2 earnings per share view $0.71 -- Thomson Reuters I/B/E/S.Q2 revenue $289.1 million versus i/b/e/s view $268 million.Bioverativ Inc - ‍full year 2017 guidance updated; expected revenue growth of 23% to 25%​.Bioverativ Inc sees full year 2017 non-gaap total revenue growth 23% to 25%.Bioverativ Inc sees full year 2017 non-gaap operating margin 41% to 44%.Fy2017 revenue view $1.09 billion -- Thomson Reuters I/B/E/S.  Full Article

Bioverativ says on June 28, entered into a credit agreement
Thursday, 29 Jun 2017 06:21am EDT 

June 29 (Reuters) - Bioverativ Inc :Bioverativ inc - on june 28, entered into a credit agreement by and among bioverativ and certain subsidiaries as borrowers - sec filing.Bioverativ inc - credit agreement provides for a $175 million unsecured, revolving credit facility.Bioverativ inc - agreement also provides, under certain conditions, co may request borrowing capacity under credit agreement be increased by $300 million.Bioverativ inc - credit agreement matures on june 28, 2020.Bioverativ inc - borrowings under credit agreement will be used to finance a portion of acquisition of true north therapeutics inc.  Full Article

Amunix Operating Inc says FDA has accepted Bioverativ's IND application for BIVV001
Wednesday, 14 Jun 2017 07:00am EDT 

June 14 (Reuters) - Bioverativ Inc :Bioverativ announces FDA acceptance of investigational new drug application for BIVV001, a novel, long-acting FVIII hemophilia therapeutic utilizing amunix XTEN® half-life extension technology.Amunix Operating Inc says FDA has accepted Bioverativ's IND application for BIVV001.  Full Article

Bioverativ announces FDA acceptance of investigational new drug application for BIVV001
Monday, 12 Jun 2017 07:00am EDT 

June 12 (Reuters) - Bioverativ Inc :Bioverativ announces FDA acceptance of investigational new drug application for BIVV001 to treat hemophilia A.Look forward to commencing our phase 1/2A clinical trial later this year.On track to initiate a phase 1/2A clinical trial in second half of 2017.  Full Article

Bioverativ to acquire True North Therapeutics
Tuesday, 23 May 2017 07:00am EDT 

May 23 (Reuters) - Bioverativ Inc -:Bioverativ to acquire clinical-stage rare disease biotechnology company, True North Therapeutics.Bioverativ Inc - deal for for an upfront payment of $400 million plus assumed cash.Bioverativ Inc - true north investors are also eligible to receive additional payments of up to $425 million contingent on achievement of future milestones.Says the acquisition will be financed through a combination of cash on hand and debt.Bioverativ Inc says has entered into a definitive agreement to acquire south san francisco-based true north therapeutics.  Full Article

BRIEF-Bioverativ’s BIVV009 achieves positive results in Phase 1B CAgD patients

* BIOVERATIV’S INVESTIGATIONAL BIVV009 DEMONSTRATES SAFETY, TOLERABILITY AND EFFICACY IN PHASE 1B CLINICAL TRIAL IN COLD AGGLUTININ DISEASE (CAGD) PATIENTS