Gamida Cell Ltd. (NASDAQ:GMDA) shares were trading more than 5% higher after-hours on Tuesday following the company’s Q3 results, and the conference call, where it discussed recent regulatory setbacks as well as new data presented over the weekend at SITC. The company’s IND for GDA-201 remains on hold, but the analysts at Oppenheimer expect a relatively quick resolution, and they believe the first patient could be dosed in early 2022.

Thursday, the company announced a new regulatory delay, pushing back guidance on the BLA filing for omidubicel into H1/22. Management cited an FDA request for a revised analysis of drug product comparability data for omidubicel manufactured in an in-house facility vs. manufacturing sites used in the Phase 3 study. Oppenheimer analysts updated their model to account for the delayed BLA filing. The analysts lowered their price target to $15 from $17, maintaining their outperform rating.