- Athersys ( NASDAQ: ATHX ) shares spiked ~8% pre-market Tuesday after announcing that the FDA granted a clinical Type B meeting to discuss the Phase 3 development of MultiStem, an experimental therapy targeted at ischemic stroke.
- The request for the meeting follows the data for MultiStem from the Phase 2 MASTERS-1 trial and Phase 2/3 TREASURE ischemic stroke trial that the company’s partner Healios completed in Japan recently.
- In the meeting scheduled for March, Athersys ( ATHX ) intends to discuss potential modifications to the ongoing pivotal Phase 3 MASTERS-2 clinical trial.
- The changes are designed to define “primary and secondary outcomes that best reflect the potential benefit of MultiStem treatment with ischemic stroke patients,” the company said.
- Read: Athersys’ ( ATHX ) valuation “is minuscule” compared to those of its rivals focused on stem cell products similar to MultiStem, Seeking Alpha contributor Arthur Frentzel wrote in October.
For further details see:
Athersys gains on FDA nod to offer Phase 3 guidance for stroke candidate