RFL news

Rafael Holdings reported narrowed Q4 and FY26 net losses driven by lower admin costs and a gain on settlements. While Q4 Net Loss narrowed to $9.2M, full year R&D expenses increased due to Cyclo Therapeutics consolidation.

Rafael Holdings disclosed that Trappsol Cyclo failed its primary endpoint in a pivotal NPC study despite positive prespecified subgroup results, resulting in a potential delay to the 2026 NDA submission.

An independent Data Monitoring Committee recommended proceeding with the Phase 3 study for Trappsol Cyclo. The therapy addresses a significant unmet medical need projected at over $920 million by 2031.

Rafael Holdings completed enrollment in its pivotal Phase 3 TransportNPC trial for Niemann-Pick disease Type C and expects to submit an NDA in the second half of 2026 following a pre-NDA FDA meeting. The company reported Q3 net loss of $4.2 million with $30.5 million in cash, positioning itself to t…

Rafael Holdings announced completion of its pivotal Phase 3 TransportNPC study evaluating Trappsol Cyclo for Niemann-Pick Disease Type C treatment, with 94 patients across 27 sites. The company expects to submit an NDA to the FDA in the second half of 2026, positioning the company toward commercial-…