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Original-Research: Jaguar Health Inc - from First Berlin Equity Research GmbH
Classification of First Berlin Equity Research GmbH to Jaguar Health Inc
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%). First Berlin Equity Research hat ein Research Update zu Jaguar Health, Inc. (ISIN: US47010C8055) veröffentlicht. Analyst Christian Orquera bestätigt seine BUY-Empfehlung und senkt das Kursziel von USD 60,00 auf USD 40,00. Zusammenfassung: Jaguar hat ein persönliches Treffen des Typs C mit der FDA abgehalten, um die statistisch signifikanten Responderdaten der vordefinierten Untergruppe von Brustkrebspatientinnen in der OnTarget-Studie der Phase 3 für Crofelemer bei krebstherapiebedingter Durchfallerkrankung (CTD) zu besprechen. Obwohl die gesamte prophylaktische Studie für alle soliden Tumorarten ihren primären Endpunkt nicht erreicht hat, zeigte die Untergruppe der Brustkrebspatientinnen, wie auf dem San Antonio Breast Cancer Symposium (SABCS) in den USA im Dezember 2024 vorgestellt, statistische Signifikanz in der Responder-Analyse über den dreimonatigen Behandlungszeitraum. Diese Ergebnisse veranlassten Jaguar, der FDA zwei parallele Zulassungswege vorzuschlagen: (1) eine neue Zulassungsstudie zur Behandlung von Patienten mit metastasiertem Brustkrebs (mBC) und (2) ein erweitertes Zugangsprogramm (d. h. compassionate use) für diejenigen Patienten mit BC, die für die nächste geplante Behandlungsstudie nicht in Frage kommen. Die FDA hat beide vorgeschlagenen Strategien akzeptiert. Jaguar beabsichtigt, ein Protokoll für eine Zulassungsstudie einzureichen, und wird außerdem den Status eines Arzneimittels für seltene Krankheiten anstreben, da die mBC-Krankheit unter die Kriterien für seltene Krankheiten fällt. Das Unternehmen plant außerdem, entweder den Status eines Therapiedurchbruchs und/oder den Fast-Track-Status anzustreben, um ein beschleunigtes Zulassungsverfahren zu unterstützen. Jaguar nutzt den konstruktiven Dialog mit der FDA, die Möglichkeit der Ausweisung als Arzneimittel für seltene Krankheiten und die beschleunigten Verfahren, um Crofelemer in den USA zur Zulassung zu bringen. Der Erfolg wird jedoch von der Durchführung der Zulassungsstudie und der Sicherung der Finanzierung in der Zwischenzeit abhängen. Wir haben unser SOTP-Modell aktualisiert, um der höheren prognostizierten Verwässerung aufgrund des derzeit niedrigeren Aktienkurses Rechnung zu tragen, was zu einem Kursziel von USD 40 führt (vorher: USD 60). Wir bestätigen unser Kaufen-Rating (Aufwärtspotenzial >1.000%). Bezüglich der Pflichtangaben gem. §85 Abs. 1 S. 1 WpHG und des Haftungsausschlusses siehe die vollständige Analyse. You can download the research here: http://www.more-ir.de/d/32934.pdf Contact for questions: First Berlin Equity Research GmbH Herr Gaurav Tiwari Tel.: +49 (0)30 809 39 686 web: www.firstberlin.com E-Mail: g.tiwari@firstberlin.com
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2162588 30.06.2025 CET/CEST
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