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BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma
BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors Updated Phase 1 clinical data are expected in the second half of 2026 SOUTH SAN FRANCISCO, Calif., April 20, 2026 (GLOBE NEWSWIRE) -- BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced that the U.S. Food and Drug Administration (FDA)
About this update from Bridgebio Oncology Therapeutics, Inc.
[{"type":"image","alt":"TheRas, Inc. (d/b/a BBOT)","displaySize":"","headline":null,"caption":"TheRas, Inc. (d/b/a BBOT)","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":143,"url":"https://media.zenfs.com/en/globenewswire.com/9479f198b092ba1412cb0ee76f46ca4a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/zl2QesQ7dM5qmBVBYYNnWQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIwMA--/https://media.zenfs.com/en/globenewswire.com/9479f198b092ba1412cb0ee76f46ca4a","width":300,"height":143}},"lazy":false},{"type":"text","content":"BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors","length":157,"tagName":"p"},{"type":"text","content":"Updated Phase 1 clinical data are expected in the second half of 2026","length":69,"tagName":"p"},{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., April 20, 2026 (GLOBE NEWSWIRE) -- BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BBO-11818 for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma.","length":415,"tagName":"p"},{"type":"text","content":""Receiving Fast Track designation from the FDA for BBO-11818 in KRAS-mutant pancreatic ductal adenocarcinoma reflects the importance and urgency of accelerating the development of our pan-KRAS inhibitor in this serious disease," said Yong Ben, MD, Chief Medical and Development Officer of BBOT. "Pancreatic cancer remains one of the most difficult-to-treat malignancies. KRAS mutations are present in the vast majority of cases, yet patients have had few targeted options. This designation will help us collaborate closely with the FDA to advance BBO-11818 as efficiently as possible for patients who need new options."","length":644,"tagName":"p"},{"type":"text","content":"This designation follows preliminary data, first released in January 2026, in which BBO-11818 monotherapy demonstrated a confirmed partial response in pancreatic cancer. In addition, anti-tumor activity was observed across dose levels and tumor types with tumor reductions at higher dose levels with a generally favorable, diffe...