Abeona’s Type A meeting with FDA done, BLA resubmission on track, says Stifel

Abeona Therapeutics management held a Type A meeting with the FDA on August 8 to discuss the complete response letter for Pz-cel, Stifel tells investors in a research note, adding that Abeona has gained the FDA’s preliminary alignment aside from two outstanding items, pending a formal review. Abeona’s steady progress since the CRL keeps the company on track toward BLA resubmission in the second half of 2024, after which management expects a six-month review, the firm notes. Stifel views these incremental updates as a positive for the stock and thinks the upside potential can be significant in light of Abeona’s less than $200M market cap. The firm made no change to its Buy rating or $21 price target.