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Jaguar Health Meeting with FDA Regarding Results of Phase 3 OnTarget Study

1. Napo Pharmaceuticals received FDA Type C Meeting for breast cancer analysis. 2. Significant responder analysis results for crofelemer presented at major symposium.

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Why Bullish?

The FDA's engagement indicates positive momentum for JAGX's drug development, similar to prior successful FDA interactions that uplifted stock prices in biotech sectors.

How important is it?

The article highlights critical advancements for a treatment relevant to a major cancer indication, indicating a cornerstone for JAGX's growth potential and investor interest.

Why Long Term?

Initial FDA discussions suggest potential future approvals, impacting market perception and value over time, as seen with other pharmaceuticals witnessing stock appreciation post-positive FDA meetings.

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The statistically significant responder analysis results for Mytesi® (crofelemer) in the OnTarget study's prespecified subgroup of patients with breast cancer were the subject of a December 2024 poster presentation at the San Antonio Breast Cancer Symposium Late-breaker abstract recently submitted to the Multinational Association of Supportive Care in Cancer (MASCC) shows additional significant results for breast cancer subgroup The American Cancer Society expects 316,950 new cases of breast cancer diagnosed in women in the US in 2025, and it's estimated that there were 4 million US women with a history of invasive breast cancer in 2022 SAN FRANCISCO, CA / ACCESS Newswire / March 27, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") family company Napo Pharmaceuticals ("Napo") today announced that the U.S. Food and Drug Administration (FDA) has granted Napo a Type C Meeting in the second quarter of 2025 to discuss the responder analysis in the prespecified subgroup of patients with breast cancer for crofelemer in Napo's Phase 3 OnTarget trial. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy.

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