FAST TRACK shares surge 10.39% intraday as FDA fast-track nicotine pouch approvals face regulatory pushback and youth risk concerns.

FAST TRACK surged 10.39% intraday after the U.S. FDA granted Fast Track designation to PAS-004, a next-generation macrocyclic MEK inhibitor developed by Pasithea Therapeutics, for the treatment of NF1-associated plexiform neurofibromas. The designation accelerates the regulatory pathway and allows for enhanced interactions with the FDA, which is seen as a significant development for Pasithea’s clinical-stage drug candidate. The news is likely to have driven investor optimism, highlighting the potential for expedited clinical and regulatory progress.