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Rafael Holdings reports Q4 and FY 2026 losses but submits FDA NDA for Niemann-Pick disease drug remibetadex.

Company Fundamentals
29 Oct 2026, 15:00 WIB
GlobeNewsWire
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Neutral
Rafael Holdings reports Q4 and FY 2026 losses but submits FDA NDA for Niemann-Pick disease drug remibetadex.

Rafael Holdings announced its financial results for Q4 and full fiscal year 2026, reporting a net loss of $9.2 million for Q4 and $29.6 million for the year, with reduced general and administrative expenses helping to lower losses. The company submitted a New Drug Application (NDA) to the FDA for remibetadex (Trappsol® Cyclo™), a treatment for Niemann-Pick Disease Type C, supported by Phase 3 trial data. Despite the Phase 3 study not meeting its primary endpoint in the overall population, a subgroup analysis showed significant slowing of disease progression. Rafael Holdings also advanced other projects, including a license for Alzheimer's treatment and a Phase II trial for head and neck cancer. The NDA submission marks a key regulatory milestone, with the FDA review and potential approval critical for the company's future prospects.

Rafael Holdings reported a net loss of $9.2 million in Q4 and $29.6 million for fiscal 2026, alongside a key NDA submission to the FDA for a Niemann-Pick Disease treatment. For readers following the health sector, here is Pluang's market snapshot as of Oct 29, 2026 18:11 WIB: out of 150 priced US health stocks, 95 rose and 47 fell. Notable movers include Novartis AG (NVS) at USD 160.96 with a 3.13% increase, Sana Biotechnology Inc (SANA) at USD 2.71 up 3.04%, and Gilead Sciences, Inc. (GILD) at USD 163.65 rising 2.80%.

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