Biovica announced a few weeks ago, that FDA requested one additional information needed for Biovica FDA approval. Analysts believe it is the final bit in the puzzle and that FDA approval is comming within a few weeks. Biovica could easily double by the FDA approval.
Pareto’s take on today’s announcement
|DiviTum’s 510(k) resubmitted to the FDA|
|Expected for later May, Biovica surprised yesterday evening with the 510(k) application for DiviTumhaving been resubmitted to the FDA. In a call with the CEO the same evening, he clarified that the FDA wanted to look at the data before it is being resubmitted and thereafter was fine with the submission. Subject to no further delays by the FDA, we expect approval before end of June. Thereafter, DiviTum will be made available to physicians and patients being treated in metastatic breast cancer setting, finding out earlier (after 2 weeks) if the given drug (CDK 4/6 inhibitor) is working or not (instead of >3 months). A crisp new readout at the disposal of physicians that we believe will change treatment monitoring practices over time. The company will update on its commercialization strategy at its capital markets day on May 17. We reiterate our Buy rating on BIOVIC with a target price of SEK 103/share.|