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Jaguar Receives Regulatory Clearance in Germany and Italy for Crofelemer for Rare Disease Study - Short Bowel Syndrome with Intestinal Failure (SBS-IF)

1. Jaguar's crofelemer receives Orphan-Drug Designation for rare diseases. 2. Phase 2 trials for SBS-IF begin in Italy and Germany.

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Why Bullish?

The Orphan-Drug Designation can significantly enhance funding and market value, similar to previous drug approvals that surged stock prices.

How important is it?

The article directly relates to JAGX’s strategy in the rare disease market, indicating potential revenue growth.

Why Long Term?

Successful trial outcomes may lead to increased market traction for JAGX over time, akin to historical cases where drug trials boosted stocks post-approval.

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JAGXNapo
This study, initiated yesterday, is one of five clinical efforts - three proof-of-concept (POC) investigator-initiated trials (IIT) and two Phase 2 studies - of crofelemer for the rare disease indications of SBS-IF and microvillus inclusion disease (MVID) in the US, EU, and/or Middle East/North Africa regions Availability of first IIT proof-of-concept results potentially in H1 2025 Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan-Drug Designation by the FDA and the European Medicines Agency (EMA) for both SBS-IF and MVID SAN FRANCISCO, CA / ACCESS Newswire / February 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family companies Napo Pharmaceuticals ("Napo") and Napo Therapeutics today announced that the clinical protocol for Napo's Phase 2 study to evaluate the efficacy of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, for the indication of SBS-IF in adults has received regulatory clearance from health authorities in Italy and Germany, where the trial will be conducted. The study initiated yesterday, February 18, 2025.

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