Bioporto A/S (BIOPOR.CO) Key Developments | Reuters.com
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Bioporto A/S (BIOPOR.CO)

BIOPOR.CO on Copenhagen Stock Exchange

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24 Jun 2016
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Latest Key Developments (Source: Significant Developments)

Bioporto: FDA rejects application for registration of NGAL Test
Monday, 30 May 2016 01:00am EDT 

Bioporto A/S : The FDA rejects application for the registration og The NGAL Test . Registration application for NGAL Test rejected on grounds that submission does not provide adequate clinical and analytical data to support a reasonable assurance of approval of device . Cannot begin commercialization of NGAL Test for clinical use in US as previously expected, whereas sales for research use continues . As a result of FDA's rejection of application, expectations for 2016 are adjusted . Sees 2016 revenues of around 23 million-26 million Danish crowns ($3.43 million - $3.88 million) (previously around 27-30 million crowns) .Sees 2016 operating loss (EBIT) of 16-18 million crowns (previously a loss of around 11-13 million crowns).  Full Article

Bioporto NGAL Forms patent upheld after EPO ruling
Wednesday, 18 May 2016 08:36am EDT 

Bioporto A/S : Says the company's NGAL Forms patent is upheld after European Patent Office (EPO) ruling .Decision is a first instance decision and can be appealed by the opponent.  Full Article

BioPorto cuts FY 2016 EBIT outlook due to warrants program
Friday, 8 Apr 2016 03:00am EDT 

BioPorto A/S:Adjusts EBIT forecast for FY 2016 due to warrants program for employees.To issue a total of 6,368,696 warrants, exercise price fixed at 4.58 Danish crowns per share.EBIT forecast for FY 2016 is adjusted: from a negative EBIT of around 7 million - 9 million crowns to a negative EBIT of around 11 million - 13 million crowns.  Full Article

BioPorto issues FY 2016 guidance
Wednesday, 16 Mar 2016 03:41am EDT 

BioPorto A/S:In FY 2016, expects to generate revenue of around 27 million – 30 million crowns, equivalent to 30–50 pct growth​.Plans higher investments in long-term growth potential at the expense of the short-term goal of becoming profitable in FY 2016.Says accordingly, in FY 2016 a negative EBIT of around 7 million – 9 million crowns, equivalent to a loss after tax of 5.5 million – 7.5 million crowns, is expected.  Full Article

BioPorto A/S enters distribution agreement with Siemens Healthcare
Monday, 11 Jan 2016 06:00am EST 

BioPorto A/S:Says has entered into a distribution agreement with Siemens Healthcare, under which BioPorto will deliver an NGAL test adapted for Siemens Healthcare’s BN II and BN ProSpec Systems‍.Says expects to see an economic effect of this agreement in H2 2016​.  Full Article

BioPorto submits FDA application for NGAL Test, forms US business platform
Friday, 25 Sep 2015 02:41am EDT 

BioPorto A/S:Submits FDA application for the NGAL Test.Alongside application process, Bioporto has initiated establishment of a business platform in US.US business platform will include the company’s own US sales and support organization in charge of the commercialization of The NGAL Test.Expects US Food and Drug Administration (FDA) approval to be achieved in early 2016.  Full Article

BioPorto completes cash issue, private placement
Monday, 31 Aug 2015 09:21am EDT 

BioPorto A/S:Completes cash issue, private placement.Issue was fully subscribed.Board has decided to issue 11,724,750 new shares against payment of 2.40 Danish crowns per share.Total proceeds from share issue amounts to 28.1 million crowns before issue costs.Part of net proceeds are expected to be used for establishing a business platform in the USA.Part of proceeds are expected to be used to complete development and marketing of new products gRAD and immunodeficiency tests as well as other projects.  Full Article

BioPorto announces private placement
Monday, 31 Aug 2015 02:40am EDT 

BioPorto A/S:Initiates private placement of up to 11,724,750 new shares to selected institutional and financial investors.Subscription price is 2.40 Danish crowns.Expected total proceeds from share issue will amount to 28,139,400 Danish crowns at a full subscription.Offering is equivalent to 9.9 pct of BioPorto's registered share capital before the capital increase.  Full Article

BioPorto A/S upgrades FY 2015 guidance
Monday, 10 Aug 2015 03:00am EDT 

BioPorto A/S:Revenue is expected to be 22 million - 23 million crowns in FY 2015.In FY 2015, an EBIT of 12 million crowns and a net loss of 10 million crowns is expected.Previous guidance for FY 2015 revenue was 22 million - 25 million crowns.Previous guidance for FY 2015 EBIT was loss of 10 million to 12 million crowns.Previous guidance for FY 2015 net loss was 8 million - 10 million crowns.  Full Article

BioPorto : progress in clinical trials for NGAL Test, launch of new generic strip test
Friday, 3 Jul 2015 04:30am EDT 

BioPorto A/S:Announces progress in clinical trials for the FDA application for The NGAL Test.Conducted a preliminary internal assessment of data from completed clinical trials in USA.Says preliminary internal assessment of data supports the further application process, including the formulation of the application, which is expected to be submitted to the FDA in September 2015 at the latest.Says antibody portfolio is extended with a generic strip test under the name gRAD (Generic Rapid Assay Device).  Full Article

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