New scientific publication focuses on DiviTum® and highlights the need for biomarkers of CDK4/6 inhibitors

A new publication in the scientific journal Frontiers in Oncology, authored by researchers at the Prato hospital in Italy, emphasize the need to find and utilize biomarkers to identify early treatment resistance and predict the likelihood of successful treatment to a new group of drugs, CDK 4/6 inhibitors. The article focuses on biomarkers and highlights DiviTum® as a technology with great potential, strong rationale and already documented pre-clinical and clinical data to evaluate CDK4/6 inhibitor efficacy.

2020-02-19T12:09:43+00:00 September 17th, 2019 08:00|News|

Plan for 510(k) submission specified – Q1 Interim Report: May-July 2019/2020

SEK thousands  Q1 19/20  Q1 18/19  May-April 18/19  Net sales  367  914  3,005  Operating profit (loss)  -6,097  -3,956  -21,718  Profit (loss) for the period  -6,068  -4,028  -21,556  Earnings per share, after dilution  -0.33  -0.23  -1.18  Significant events during the first quarter  Targeted new share issue for SEK 60 million to European and Swedish institutional investors [...]

2020-02-19T12:09:43+00:00 August 29th, 2019 08:00|Regulatory|

The path to 510(k) submission defined after FDA feedback

Biovica has completed the supplement II process which includes written feedback and physical meetings with the FDA in order to define the process for clinical validation for 510(k) submission for DiviTum®. Biovica also announces that an agreement with a leading oncology group has been signed. The agreement enables Biovica to analyze samples from a large, high impact, clinical trial within metastatic breast cancer. Biovica will use the results in the 510(k) FDA submission and has chosen to extend the time plan in order to include the results as an essential part of the submission.

2020-02-19T12:09:43+00:00 August 28th, 2019 07:55|Regulatory|

Biovica completed meeting with the FDA

On the 22nd of July, Biovica had fruitful meeting with the FDA regarding Supplement II that discusses the approach for clinical validation of DiviTum. Next step is to document the conclusions from the meeting, which the FDA will review and signoff. This process will take a maximum of 45 days. Thereafter, Supplement II will be completed, [...]

2020-02-19T12:09:43+00:00 July 25th, 2019 12:16|News|

FDA-process and commercialization on track. New study results confirm the potential. Year-End Report (May-January 2018/2019)

SEK thousands                         Q4 18/19    Q4 17/18 May-April 18/19 May-April 17/18 Net sales                                               1,715           1,433                 3,005                    2,723 Operating profit (loss)                        -8,569          -4,132              -21,718                -17,956 Loss for the period                              -8,631          -4,176              -21,556                -18,010 Earnings per share, after dilution        -0.47            -0.24                  -1.18                     -1.01

2020-02-19T12:09:43+00:00 June 14th, 2019 08:00|Regulatory|

Biovica publishes a summary of study-results in breast cancer with DiviTum®

Biovica has a comprehensive study program with DiviTum® to demonstrate the clinical value for cancer patients. Biovica has published a summary brochure in order to share knowledge about results achieved so far with DiviTum® to researchers, oncologists and other stakeholders. The summary describes all clinical studies presented where DiviTum® is used to evaluate response to breast cancer treatment.

2020-02-19T12:09:43+00:00 May 22nd, 2019 09:45|News|

Biovica attends ASCO in Chicago

Uppsala, Sweden, May 8, 2019: Biovica will participate in the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago May 31-June 4, 2019

2020-02-19T12:09:43+00:00 May 8th, 2019 11:09|News|

Announcement from Biovica’s extra general meeting

The extra general meeting ("EGM") of Biovica International AB (publ) ("Biovica" or the "Company") was held today on 2 May 2019 and the following resolutions were passed by the meeting. Resolution regarding approval of the board of directors' resolution to issue new class B shares with deviation from the shareholders' preferential rights

2020-02-19T12:09:43+00:00 May 2nd, 2019 13:30|Regulatory|