LGVN - Longeveron spikes after FDA's Fast Track Designation for lead candidate

• The shares of clinical-stage biotech Longeveron Inc. ( NASDAQ: LGVN ) jumped in the pre-market trading Wednesday after the company announced that the FDA issued Fast Track Designation for its lead asset Lomecel-B as a treatment for Hypoplastic Left Heart Syndrome (HLHS).
• A rare congenital heart defect impacting cardiac function, HLHS affects an estimated ~1,000 babies per year in the U.S.
• The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
• If certain criteria are met, such programs will also be able to win the Accelerated Approval and Priority Review, enabling them to reach patients sooner.
• A cell-based therapeutic candidate, Lomecel-B, is currently undergoing a Phase 2a randomized clinical trial involving 38 patients.

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