Following the submission of an application in September, the US FDA has now granted Fast Track designation to RhoVac’s lead drug RV001.

Although we had expected this, it indicates a third-party validation for RhoVac and its ongoing clinical programme. Importantly, this designation should make RV001 more appealing to potential partners, given it eases some of the regulatory processes ahead.

Other developments include the news that RhoVac’s Phase I/II data have been published in a peer-reviewed article, which gave some additional details. The COVID-19 pandemic continues to cause delays, but the BRaVac study timelines still fit within the existing budget. Our valuation is SEK64.2/share (vs SEK61.8/share).

Link to the analysis