The U.S. Food and Drug Administration (FDA) has granted fast track status to KYV-101, Kyverna Therapeutics’ cell-based therapy candidate for people with progressive forms of multiple sclerosis (MS) that are treatment-resistant.
The FDA designation is intended to accelerate the development of therapies that aim to address unmet medical needs for people with serious or life-threatening conditions. Among other incentives, it makes Kyverna eligible for more frequent meetings and discussions with the FDA about KYV-101’s clinical developmental plan.
The award of fast track status follows the FDA’s clearance, earlier this month, of a Phase 2 trial (NCT06138132) to test KYV-101 in people with progressive disease types whose condition worsens despite the use of standard MS treatments.
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