Press Releases

Nomination Committee for Biovica for the 2021 Annual General Meeting

The Nomination Committee prior to the 2021 Annual General Meeting will consist of three members, who shall represent the two shareholders with the most number of shares who accept the assignment to be part of the Nomination Committee as of December 31, 2020, and the Chairman of the Board. The Nomination Committee then appoints a chairman among its members.

February 26, 2021

FDA resumes review of DiviTum®TKa submission

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510(k)-submission for DiviTum®TKa.

January 29, 2021

Biovica’s DiviTum®TKa in early treatment resistance trial

DiviTum®TKa has been selected to be included in the new prospective clinical study TIRESIAS, with the aim of investigating if DiviTum®TKa can be used to identify early resistance to treatment by a CDK4/6 inhibitor in combination with an aromatase inhibitor in breast cancer patients.

January 18, 2021

FDA resource reallocation continues to impact DiviTum®TKa timeline

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica’s submission.

January 16, 2021

Biovica’s CEO and main shareholder lends shares for redemption of option program

Biovica’s CEO and main shareholder Anders Rylander has, to facilitate the administration of the company’s warrant program 3, lent 127,000 shares to Pareto Securities AB.

January 12, 2021

Biovica Q2 Interim Report August-October 2020/2021

Convincing study results and application submitted to the FDA – commercialization just around the corner

December 3, 2020

Biovica’s DiviTum®TKa included in new UK breast cancer study

DiviTum®TKa has been selected to be included in a new prospective study of women with hormone receptor positive metastatic breast cancer. The aim of including DiviTum®TKa in the study is to investigate if this marker can be used for disease monitoring during treatment with a CDK4/6 inhibitor, which in combination with an aromatase inhibitor is considered standard of care for this subgroup of patients.

November 23, 2020

Multicenter study PYTHIA presents positive DiviTum®TKa results

Biovica, active in cancer diagnostics, today announced that positive DiviTum®TKa results from the European multicenter study PYTHIA will be presented at the world´s leading breast cancer conference, SABCS, in early December.

November 20, 2020

CDK 4/6 dosing study supports DiviTum®TKa as an early and effective tool in treatment monitoring and prediction of response

Biovica, active in cancer diagnostics, today announced that positive DiviTum®TKa results from a clinical study at the University of Nebraska Medical Center and Washington University School of Medicine, US, will be presented at the world´s leading breast cancer conference, SABCS. The study supports using DiviTum®TKa to monitor efficacy during treatment and predict response to the CDK 4/6 inhibitor palbociclib.

November 19, 2020

Biovica announces initial results in clinical genomics study of DiviTum®TKa

November 18, 2020 — Biovica, active in cancer diagnostics, today announced that initial results from the PROMISE study (NCT03281902) will be presented at the San Antonio Breast Cancer Symposium (December 8-11, 2020).

November 18, 2020