FDA Places Lucid-MS IND on Clinical Hold, Timelines Withdrawn, Director Resigns
QNTM•On May 28, 2026, the US FDA placed the IND for Lucid-21-302 (Lucid-MS) on clinical hold requiring additional data. Quantum is reviewing FDA comments, has withdrawn previous Phase 2 timelines and timeline targets, and announced Dr. Lakshmi P. Kotra’s resignation as director effective June 1, 2026.
1. FDA Imposes Clinical Hold on Lucid-MS IND
On May 28, 2026, the FDA placed the Investigational New Drug application for Lucid-21-302 (Lucid-MS) on clinical hold, requesting additional information before allowing any clinical studies to proceed. Quantum has initiated a thorough review of the agency’s comments and plans to work closely with regulators to prepare a comprehensive response package.
2. Withdrawal of Development Timelines
In light of the clinical hold, Quantum has withdrawn all previously disclosed timelines for FDA review completion, Phase 2 trial initiation and anticipated interim data milestones. The company warns that no timing projections should be relied upon until further regulatory feedback is received.
3. Director Resignation and Advisory Role
Effective June 1, 2026, Dr. Lakshmi P. Kotra resigned from his position as director and all roles at Quantum BioPharma, citing personal and professional commitments. He will continue to support the company as a senior clinical advisor while the Lucid-MS development program progresses.
