Abeona Therapeutics Inc shares jumped 15% to $4.96 in late-morning trading on Monday after the US Food and Drug Administration (FDA) said it would expedite a review of pz-cel (prademagene zamikeracel), the company's proposed treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare, inherited connective-tissue disorder.
The clinical-stage biopharmaceutical company had previously stated that it expected an FDA decision on priority-review status by late November.
Abeona noted the FDA set a target action date of May 25 for the application, and that the agency doesn't currently plan to hold an advisory committee meeting.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Shares of Abeona Therapeutics have gained 73% year to date.
Contact Sean at sean@proactiveinvestors.com