First Berlin Equity Research has published a research update on Jaguar Health, Inc. (ISIN: US47010C8055). Analyst Christian Orquera reiterated his BUY rating and decreased the price target from USD 60.00 to USD 40.00.

Abstract
Jaguar has held a Type C face-to-face meeting with the FDA to discuss statistically significant responder data from the prespecified subgroup of breast cancer patients in the phase 3 OnTarget trial for crofelemer in cancer therapy-related diarrhoea (CTD). Although the overall prophylactic trial for all solid tumour types did not meet its primary endpoint, the breast cancer subgroup, as presented at the San Antonio Breast Cancer Symposium (SABCS) in the US in December 2024, showed statistical significance in the responder analysis over the 3-month treatment period. These results prompted Jaguar to propose two parallel regulatory paths to the FDA: (1) a new pivotal treatment trial in metastatic breast cancer (mBC) patients and (2) an expanded access programme (i.e. compassionate use) for those patients with BC that are ineligible for the next planned treatment trial. The FDA accepted both proposed strategies. Jaguar intends to submit a pivotal trial protocol and will also pursue an orphan drug designation, as the mBC disease qualifies under orphan criteria. The company also plans to seek either Breakthrough Therapy and/or Fast Track designation to support an expedited approval process. Jaguar is leveraging a constructive FDA dialogue, orphan designation potential, and expedited pathways to advance crofelemer towards approval in the US. However, success will depend on executing the pivotal trial and securing funding in the interim. We have updated our SOTP model to reflect the higher forecast dilution due to the current lower share price, resulting in a price target of USD 40 (previously: USD 60). We confirm our Buy rating (upside >1,000%).