Jaguar Health: FDA Dialogue and Strategic Trials

First Berlin Equity Research has updated its stance on Jaguar Health, reflecting a buy recommendation with a decreased target price of USD 40, down from USD 60. Following a crucial meeting with the FDA, Jaguar Health focused on its phase 3 OnTarget trial for crofelemer, targeting cancer therapy-related diarrhea. While the trial for various solid tumors didn't meet the primary endpoint, a breast cancer subgroup showed significant results over three months.

The FDA approved Jaguar's dual regulatory strategy: a new pivotal trial for metastatic breast cancer patients and an expanded access program for ineligible patients. Jaguar aims to secure orphan drug designation and is exploring expedited approval pathways to advance crofelemer's U.S. approval, contingent on successful trials and interim funding fulfillment.