{"id":953046,"date":"2026-04-20T16:15:02","date_gmt":"2026-04-20T20:15:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/"},"modified":"2026-04-20T16:15:02","modified_gmt":"2026-04-20T20:15:02","slug":"bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/","title":{"rendered":"BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma"},"content":{"rendered":"
\n

\n 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<\/em>\n <\/p>\n

\n Updated Phase 1 clinical data are expected in the second half of 2026<\/em>\n <\/p>\n

SOUTH SAN FRANCISCO, Calif., April 20, 2026 (GLOBE NEWSWIRE) — BridgeBio Oncology Therapeutics, Inc. (\u201cBBOT\u201d) (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.<\/p>\n

“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.\u00a0“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.”<\/p>\n

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, differentiated safety profile in dose escalation.<\/p>\n

While KRASG12C <\/sup>inhibitors have demonstrated promising clinical efficacy, there remains a clear unmet medical need for therapies targeting cancers that carry other KRAS mutations, such as KRASG12D<\/sup> and KRASG12V<\/sup>. BBO-11818 was developed to address this gap and is specifically designed as a potent pan-KRAS inhibitor with strong binding affinity for KRAS, high selectivity over HRAS and NRAS, and the ability to achieve high levels of KRAS inhibition in both the ON and OFF states. BBO-11818 is being evaluated as monotherapy, in combination with standard-of-care therapies, or alongside BBOT\u2019s RAS:PI3K\u03b1 breaker, BBO-10203.<\/p>\n

Fast Track designation is intended to help rapidly advance the development and review process for promising therapeutic candidates for serious conditions that may fill an unmet medical need.<\/p>\n

\n About BBO-11818<\/strong>
\n
BBO-11818 is a selective, orally bioavailable non-covalent inhibitor that targets KRAS in both the ON and OFF states, has high selectivity over HRAS and NRAS, and displays strong activity in KRAS-mutant preclinical models, including KRASG12D<\/sup> and KRASG12V<\/sup>. In addition, it potently suppresses MAPK signaling and inhibits cell proliferation in KRAS-mutant cell lines. BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101<\/a> trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors.<\/p>\n

\n About BBOT<\/strong>
\n
BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K\u03b1 malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information, please visit\u00a0www.bbotx.com<\/a>\u00a0and follow us on\u00a0LinkedIn<\/a>.<\/p>\n

\n Forward-Looking Statements<\/strong>\u00a0
This press release\u00a0contains\u00a0forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements in this press release that are not historical facts may be deemed forward-looking statements, \u00a0which generally are accompanied by words such as \u201cbelieve,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cestimate,\u201d \u201ccontinue,\u201d \u201canticipate,\u201d \u201cintend,\u201d \u201cexpect,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201cplan,\u201d \u201cpredict,\u201d \u201cpotential,\u201d \u201cseem,\u201d \u201cseek,\u201d \u201cfuture,\u201d \u201coutlook\u201d and similar expressions that predict or indicate future events or trends. These statements are based on various assumptions,\u00a0whether or not\u00a0identified\u00a0in this press release, and are the current expectations of BBOT\u2019s management and are not predictions of actual performance. Many actual events and circumstances are beyond the control of BBOT. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to\u00a0the timing of expected regulatory and business milestones, including interactions with regulatory authorities, the progress of\u00a0enrollment\u00a0in clinical trials and availability of data from ongoing and planned clinical trials;\u00a0and those factors discussed in documents BBOT has filed or will file with the U.S. Securities and Exchange Commission.\u00a0
\u00a0\u00a0
In addition, forward-looking statements reflect BBOT\u2019s expectations, plans, or forecasts of future events and views as of the date of this press release and are qualified in their entirety by reference to the cautionary statements\u00a0herein. BBOT anticipates that\u00a0subsequent\u00a0events and developments will cause BBOT\u2019s assessments to change. These forward-looking statements should not be relied upon as any guarantee, assurance, prediction or definitive statement of fact or probability or as representing BBOT\u2019s assessments as of any date\u00a0subsequent to\u00a0the date of this press release. Neither BBOT, nor any of its affiliates undertake any obligation to update these forward-looking statements, except as required by law.\u00a0<\/p>\n

\n BBOT Contacts:<\/strong>\n <\/p>\n

\n Investor Contact:<\/strong>
\n
Heather Armstrong, Head of Investor Relations
BBOT
Investors@BBOTx.com<\/strong><\/a><\/p>\n

\n Media Contact:<\/strong>
\n
Jake Robison
Inizio Evoke Comms
Jake.robison@inizioevoke.com<\/strong><\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

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. (\u201cBBOT\u201d) (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. “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,” … <\/p>\n

Continue reading “BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-953046","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nBBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma - Market Newsdesk\" \/>\n<meta property=\"og:description\" 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 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. (\u201cBBOT\u201d) (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. “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,” … Continue reading "BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-20T20:15:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY5MzQxOCM3NTQ1NzcyIzIzMDI0OTc=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma\",\"datePublished\":\"2026-04-20T20:15:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\\\/\"},\"wordCount\":839,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTY5MzQxOCM3NTQ1NzcyIzIzMDI0OTc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\\\/\",\"name\":\"BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma - 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(\u201cBBOT\u201d) (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. “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,” … Continue reading \"BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/","og_site_name":"Market Newsdesk","article_published_time":"2026-04-20T20:15:02+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY5MzQxOCM3NTQ1NzcyIzIzMDI0OTc=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma","datePublished":"2026-04-20T20:15:02+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/"},"wordCount":839,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY5MzQxOCM3NTQ1NzcyIzIzMDI0OTc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/bbot-granted-u-s-fda-fast-track-designation-for-bbo-11818-for-the-treatment-of-adult-patients-with-advanced-kras-mutant-pancreatic-ductal-adenocarcinoma\/","name":"BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma - 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