FAST TRACK shares surge 21.95% premarket after FDA grants fast track designation to PAS-004 for NF1 tumor treatment.

FAST TRACK surged 21.95% in premarket trading following news that the FDA granted Fast Track designation to Pasithea Therapeutics’ drug candidate, PAS-004, for the treatment of NF1-associated plexiform neurofibromas. This regulatory milestone accelerates drug development timelines and increases the likelihood of expedited approval. Additionally, A2 Biotherapeutics received Fast Track status for its CAR T-cell therapy, A2B543, further reinforcing the broader theme of fast-track designations driving momentum in the sector. These developments are likely to have boosted investor sentiment toward companies benefiting from FDA fast-track programs.