FDA blow for Polish myeloid leukemia drug candidate

Shares of Poland’s largest biotech firm Selvita (WSE:SLV) plunged 17.2% to 45.12 zlotys on Monday, after the company revealed receipt of a clinical hold on the development of its acute myeloid leukemia (AML) drug by the US regulator.

Selvita said that the US Food and Drug Administration has placed a full clinical hold on the Phase I/II clinical trial of SEL24 in patients with relapsed/refractory (R/R) AML, being conducted in the USA. Selvita received a clinical hold letter from the FDA on October 6 and plans to work diligently with the agency and seek the release of the clinical hold.

Since March this year, the drug is partnered with Italy’s Menarini Group, which should take over the development in due course. Selvita currently is still the sponsor of the trial and is working with Menarini to respond to the FDA. Selvita will also wait for the resolution of the clinical hold before continuing with its fundraising plans announced in August 2017. The deal with Menarini is worth a potential 90 million euros ($105 million) to Selvita.