News

Biovica completes 510(k) submission for DiviTum®TKa to the FDA

Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).

September 25, 2020

Bulletin from the annual general meeting in Biovica

The following resolutions were passed at the annual general meeting of Biovica AB (publ) on 27 August 2020 in Uppsala.

August 27, 2020

Biovica Q1 Interim Report: May-July 2020/2021

Clinical validation completed, work with the FDA submission in the final phase

Biovica carries out a directed share issue of Class B shares and raises proceeds of approximately SEK 148 million

Biovica International AB (“Biovica” or the “Company”) has successfully completed a directed share issue of 4,700,000 Class B shares corresponding to approximately SEK 148 million (the “Directed Issue”). The subscription price in the Directed Issue has been determined to SEK 31.5 per share through an accelerated book building procedure performed by Pareto Securities AB (“Pareto Securities”). Due to significant demand, the gross proceeds in the Directed Issue was increased from the SEK 110 million indicated in the Company’s press release earlier today. A number of Swedish and international institutional investors participated, including Andra AP-fonden, Coeli Asset Management and Lancelot Asset Management.

August 26, 2020

Biovica intends to carry out a directed share issue of Class B shares

Biovica International AB (”Biovica” or the ”Company”) has engaged Pareto Securities AB (“Pareto Securities”) to explore the conditions for carrying out a directed share issue of Class B shares, corresponding to approximately SEK 110 million through an accelerated bookbuilding procedure (the “Directed Issue”).

Biovica successfully completes clinical validation for DiviTum® TKa FDA submission

Biovica today announces that the clinical validation of the blood test DiviTum® TKa has been completed, demonstrating the clinical value of the product. The clinical validation is the final part of Biovica’s application for US market approval. Biovica remains on schedule to submit its regulatory filing during September 2020.

Notice to AGM for Biovica International AB

The Board of Directors of Biovica International AB, corporate identity number 556774-6150, hereby convenes the Annual General Meeting on 27 August 2020 at 16:00 in the company’s premises at Dag Hammarskjölds väg 54B, Uppsala Science Park, Uppsala.

July 22, 2020

Biovica International AB – Annual Report for the fiscal year 2019/2020 published

Biovica’s annual report for the fiscal year 2019/2020 is published on our website https://biovica.com/investor-relations/financials/ Contact Anders Rylander, CEOPhone: +46-18-444 48 35E-mail: anders.rylander@biovica.com Cecilia Driving, EVP CFO/HR/IRPhone +46-73-125 92 47E-mail: cecilia.driving@biovica.com Biovica – Treatment decisions with greater confidence Biovica develops and commercializes blood-based biomarker assays to evaluate efficacy of cancer treatments. Biovica’s assay DiviTum® measure cell proliferation […]

June 30, 2020

Biovica completes analytical validation as part of FDA application

Biovica, active in cancer diagnostics, today announced that the analytical validation of the blood test DiviTum has been completed. The validation aims to verify technical and precision requirements defined in consultation with the US Food and Drug Administration (FDA). The analytical validation is an important part of the application for US market approval.

June 17, 2020

Biovica Year-end Report for 2019/2020:

Preparations for the launch of DiviTum® have started

June 5, 2020