Key Developments: Emergent BioSolutions Inc (EBS)

EBS on New York Consolidated

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27 May 2015
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Latest Key Developments (Source: Significant Developments)

Emergent BioSolutions Inc raises FY 2014 outlook
Thursday, 6 Nov 2014 04:04pm EST 

Emergent BioSolutions Inc:Expects FY 2014 total revenues to be in the range of $440 to $460 mln.Expects FY 2014 GAAP net income to be in the range of $35 to $45 mln.Expects FY 2014 non-GAAP adjusted net income to be in the range of $50 to $60 mln.FY 2014 revenue of $443 mln, net income of $44 mln - Thomson Reuters I/B/E/S.  Full Article

Emergent BioSolutions Inc initiates final pivotal study to support licensure of BioThrax at Large Scale
Tuesday, 23 Sep 2014 07:00am EDT 

Emergent BioSolutions Inc:Initiates the pivotal non-clinical efficacy study to demonstrate that BioThrax(Anthrax Vaccine Adsorbed) manufactured at large scale in the company's new modern facility, Building 55.Says it is comparable to the BioThrax currently manufactured in its approved facility, Building 12.Data from this study will be used to support licensure of Building 55.BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for prevention of anthrax disease.Says primary objectives of this randomized, observer-blinded study are to demonstrate consistency of three BioThrax vaccine lots manufactured in Building 55 based on lot-to-lot equivalence.As well as to demonstrate comparability of the three Building 55 lots with a Building 12 lot based on non-inferiority.  Full Article

Emergent BioSolutions Inc awarded contract to develop a dry formulation of NuThrax, a Next Generation Anthrax Vaccine
Monday, 8 Sep 2014 01:52pm EDT 

Emergent BioSolutions Inc:Signs a contract with the National Institute of Allergy and Infectious Diseases (NIAID), part of \ National Institutes of Health (NIH).Contract to develop dry formulation of NuThrax (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, company's next generation anthrax vaccine candidate.This five-year contract, valued at up to $29 mln, provides funding for manufacturing and non-clinical activities through the preparation of an Investigational New Drug application to the U.S. Food and Drug Administration.Dry formulation of NuThrax is intended to increase stability of vaccine candidate at ambient and higher temperatures, with objective of eliminating need for cold chain during shipping and storage.  Full Article

Emergent BioSolutions Inc and MorphoSys AG sign license agreement to co-develop and commercialize prostate cancer drug candidate ES414
Tuesday, 19 Aug 2014 05:30pm EDT 

Emergent BioSolutions Inc and MorphoSys AG:Says agreement for joint development and commercialization of Emergent's preclinical bi-specific antibody, ES414, targeting prostate cancer.Under terms of agreement, Emergent will receive upfront payment of $20 mln and milestone payments of up to $163 mln.These milestone payments are linked to specific events, including successful development of ES414 in several indications and securing approval in certain territories.Emergent and MorphoSys will jointly develop ES414, with MorphoSys bearing 64 pct and Emergent 36 pct of total costs.Emergent will retain commercialization rights in U.S. and Canada, with tiered royalty obligation to MorphoSys, from mid-single digit up to 20 pct.MorphoSys will gain worldwide commercialization rights excluding U.S. and Canada, with low single digit royalty obligation to Emergent.Emergent will manufacture and supply clinical material from manufacturing facilities in Baltimore, Maryland.Additional financial details were not disclosed.  Full Article

U.S. Government Exercises contract options valued at $18.9 mln for Emergent BioSolutions' Vaccinia Immune Globulin Intravenous Program
Friday, 8 Aug 2014 07:00am EDT 

Emergent BioSolutions Inc:Says Centers for Disease Control and Prevention (CDC) has exercised options under contract 200-2012-52242 for the supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS).VIGIV is a therapeutic licensed by the U.S. Food and Drug Administration (FDA) for the treatment of complications due to smallpox vaccination.Says contract options, valued at $18.9 mln over three years, provide for work required to maintain FDA licensure of VIGIV and to collect plasma for future manufacturing.  Full Article

Emergent BioSolutions Inc gives Q3 2014 revenue guidance in line with analysts' estimates; raises FY 2014 revenue guidance; reaffirms FY 2014 net income guidance
Thursday, 7 Aug 2014 04:04pm EDT 

Emergent BioSolutions Inc:Increases FY 2014 total revenue forecast to $425 to $450 million, from $415 to $445 million.Anticipates Q3 2014 total revenue of $110 to $125 million.Reaffirms its guidance for FY 2014 adjusted net income of $40 to $50 million and GAAP net income of $30 to $40 million.Q3 2014 revenue of $125 million - Thomson Reuters I/B/E/S.FY 2014 revenue of $432 million and net income of $44 million - Thomson Reuters I/B/E/S.  Full Article

Emergent BioSolutions Inc submits biologics license application to FDA for Anthrax Immune Globulin Intravenous (Human)
Thursday, 7 Aug 2014 07:00am EDT 

Emergent BioSolutions Inc:Submits Biologics License Application to U.S. Food and Drug Administration (FDA) for Anthrax Immune Globulin Intravenous (Human) [AIGIV] as part of development contract with the Biomedical Advanced Research and Development Authority (BARDA).AIGIV, which was acquired in Cangene acquisition completed earlier this year, is being developed as an intravenous therapeutic treatment for inhalation anthrax.AIGIV is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that targets the anthrax toxins of Bacillus anthracis, the bacteria that causes anthrax disease.It is prepared using plasma collected from healthy, screened donors who have been immunized with BioThrax((reg))(Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine for the prevention of anthrax disease.AIGIV was evaluated through studies conducted in animal models of inhalation anthrax and was granted Orphan Drug designation by FDA in 2008.AIGIV is being developed as part of a $160 million contract with the Biomedical Advanced Research and Development Authority, within the office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.Under this contract, which was awarded in 2005, 10,000 doses of AIGIV have been delivered to the U.S. Strategic National Stockpile and the company will receive $7 mln payment upon FDA approval of AIGIV.  Full Article

Emergent BioSolutions Inc reaffirms FY 2014 outlook; gives FY 2014 adjusted net income outlook below analysts' estimates; gives Q2 2014 revenue outlook below analysts' estimates
Thursday, 8 May 2014 04:03pm EDT 

Emergent BioSolutions Inc:Reaffirms FY 2014 outlook.Expects FY 2014 total revenue of $415 to $445 mln.Expects FY 2014 net income of $30 to $40 mln.Expects FY 2014 adjusted net income of $40 to $50 mln.Expects Q2 2014 total revenue of $95 to $110 mln.FY 2014 revenue of $439 mln, net income of $51 mln - Thomson Reuters I/B/E/S.Q2 2014 revenue of $119 mln - Thomson Reuters I/B/E/S.  Full Article

Emergent BioSolutions Inc and FDA finalize comparability protocols enabling manufacturing of BioThrax Consistency Lots in Building 55
Tuesday, 22 Apr 2014 07:00am EDT 

Emergent BioSolutions Inc:Initiates to manufacturing of BioThrax (Anthrax Vaccine Adsorbed) consistency lots in Building 55, following review by U.S. Food and Drug Administration (FDA) of Manufacturing and Non-Clinical Study Protocols submitted by company supporting Building 55 comparability program.Goal of comparability program is to generate data that will show BioThrax manufactured at large scale in Building 55 is comparable to BioThrax manufactured in approved facility, Building 12.BioThrax is only FDA-licensed vaccine for prevention of anthrax disease.  Full Article

Emergent BioSolutions Inc receives Orphan Drug designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease
Monday, 21 Apr 2014 07:00am EDT 

Emergent BioSolutions Inc:U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in U.S.This designation provides incentives to BioThrax PEP Program, including waiver of Biologics License Application (BLA) supplemental regulatory filing fee and marketing exclusivity of up to seven years.  Full Article

BRIEF-Evolva Holding completes transfer of EV-035 to Emergent BioSolutions

* Completes transfer of EV-035 to Emergent BioSolutions, triggering a $4 million payment

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