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Jaguar Health Announces Preliminary Discussion with FDA to Evaluate Breakthrough Therapy Designation for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)

Jaguar Health (JAGX)Jaguar HealthFDA / regulatory

Pediatric patients with Intestinal Failure (IF) due to MVID, an ultrarare congenital disorder with lethal natural history, that has no available therapies and needs lifelong total Parenteral Support (PS), could benefit from expedited development of oral crofelemer via Breakthrough Therapy

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Jaguar Health

Jaguar Health is a biopharmaceutical company focused on gastrointestinal and rare-disease therapies, with Mytesi as a key commercial asset. Its story combines niche commercialization with a pipeline aimed at high-unmet-need GI indications.

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Jaguar Health Announces Active Treatment Only Continuation of Pivotal Multicenter Clinical Trial in Pediatric Patients with Microvillus Inclusion Disease (MVID) to Support a New Drug Application (NDA) for Liquid Oral Crofelemer

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2.12M USD
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NASDAQ
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Biopharma
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San Francisco, California