BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma

BridgeBio Oncology Therapeutics (Nasdaq: BBOT) announced the U.S. FDA has granted Fast Track designation to BBO-11818 for treating adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma on April 20, 2026.

Rhea-AI Summary

BridgeBio Oncology Therapeutics (Nasdaq: BBOT) announced the U.S. FDA has granted Fast Track designation to BBO-11818 for treating adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma on April 20, 2026.

BBO-11818 is a pan-KRAS inhibitor in a Phase 1 trial (KONQUER-101); preliminary January 2026 data showed a confirmed partial response in pancreatic cancer and dose-dependent tumor reductions. Updated Phase 1 data expected in the second half of 2026.

Positive

• FDA Fast Track designation for BBO-11818 (KRAS-mutant pancreatic cancer)
• Confirmed partial response in pancreatic cancer in January 2026 data
• Observed anti-tumor activity across dose levels in Phase 1

Negative

• BBO-11818 remains in Phase 1—efficacy and safety not yet established
• Updated clinical data not expected until second half of 2026

Argus Apr 21 session

+2.16% close to close Open Argus

Details

News Market Reaction – BBOT

On Apr 21, the first trading day after this news, BBOT closed 2.16% above the previous close.

Data tracked by StockTitan Argus for the Apr 21 session.

Key Figures

Phase: Phase 1 Updated data timing: H2 2026 Tumor reduction: 56% +5 more

Phase

Phase 1

KONQUER-101 trial for KRAS-mutant solid tumors

Updated data timing

H2 2026

Updated Phase 1 BBO-11818 clinical data expected

Tumor reduction

56%

Confirmed partial response in pancreatic cancer for BBO-11818

Objective response rate

65% (11/17)

KRASG12C NSCLC with BBO-8520 monotherapy (prior clinical data)

6-month PFS

66%

KRASG12C NSCLC BBO-8520 monotherapy (prior clinical data)

Dose selection

500 mg QD

Selected expansion dose for BBO-10203 (prior data)

Cash balance

$425.5M

Year-end 2025 cash, cash equivalents and marketable securities

Shares outstanding

80,032,823

As of March 2, 2026 from 10-K / 424B3

Previous Clinical trial Reports

3 past events · Latest: Jan 07

Same Type 3 events

1. Jan 07

   Phase 1 data update

   24h Move

   +4.4%

   Preliminary Phase 1 data across three RAS/PI3Kα programs with strong efficacy signals.

2. Oct 25

   Preclinical combo data

   24h Move

   +3.2%

   Preclinical data for BBO-10203 showing KRAS-mutant tumor growth inhibition and combo benefits.

3. Oct 23

   Preclinical BBO-11818 data

   24h Move

   +0.8%

   Preclinical results demonstrating potent pan‑KRAS inhibition and tumor regressions for BBO-11818.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fast track designation, phase 1, pan-kras inhibitor, kras-mutant, +4 more

8 terms

fast track designation regulatory

"the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BBO-11818"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

phase 1 medical

"BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

pan-kras inhibitor medical

"the development of our pan-KRAS inhibitor in this serious disease"

A pan-KRAS inhibitor is a drug designed to block multiple common mutant forms of the KRAS protein, which can drive cancer cell growth. Investors care because such drugs can potentially treat a broader group of tumors with KRAS mutations—like a single adapter that fits several broken machines—so clinical success could open a larger market but also carries typical drug-development and regulatory risks.

kras-mutant medical

"subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors"

A KRAS-mutant tumor carries a change in the KRAS gene that makes cells behave as if a growth “gas pedal” is stuck down, driving uncontrolled cancer growth. For investors, this matters because KRAS mutations define a specific patient subgroup, influence how well therapies work, and determine whether targeted drugs or diagnostic tests will be needed — all of which affect the size of the market, clinical trial results, and regulatory prospects.

partial response medical

"BBO-11818 monotherapy demonstrated a confirmed partial response in pancreatic cancer"

A partial response is a clinical outcome where a treatment produces a clear, measurable improvement in a disease — for example a substantial shrinkage of a tumor or reduction in symptom measures — but does not eliminate the disease entirely. For investors it signals meaningful efficacy that can support regulatory progress, further trials, or commercial potential, like seeing a product gain market traction even though it hasn’t achieved a complete cure.

objective response rate medical

"reported preliminary Phase 1 safety and antitumor data ... 65% ORR (11/17)"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival medical

"and 66% 6-month PFS in KRASG12C NSCLC with BBO-8520 monotherapy"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

restricted stock units financial

"He also received 23,330 restricted stock units, each representing one share"

Restricted stock units are a type of company reward where employees are promised shares of stock, but they only fully own these shares after meeting certain conditions, like staying with the company for a set time. They matter because they can become valuable assets and are often used to motivate employees to help the company succeed.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

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) 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," 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."

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.

While KRAS^G12C inhibitors have demonstrated promising clinical efficacy, there remains a clear unmet medical need for therapies targeting cancers that carry other KRAS mutations, such as KRAS^G12D and KRAS^G12V. 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’s RAS:PI3Kα breaker, BBO-10203.

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.

About BBO-11818
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 KRAS^G12D and KRAS^G12V. 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 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors.

About BBOT
BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3Kα 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 www.bbotx.com and follow us on LinkedIn.

Forward-Looking Statements 
This press release contains forward-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,  which generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends. These statements are based on various assumptions, whether or not identified in this press release, and are the current expectations of BBOT’s 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 the timing of expected regulatory and business milestones, including interactions with regulatory authorities, the progress of enrollment in clinical trials and availability of data from ongoing and planned clinical trials; and those factors discussed in documents BBOT has filed or will file with the U.S. Securities and Exchange Commission. 
  
In addition, forward-looking statements reflect BBOT’s 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 herein. BBOT anticipates that subsequent events and developments will cause BBOT’s 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’s assessments as of any date subsequent to the 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. 

BBOT Contacts:

Investor Contact:
Heather Armstrong, Head of Investor Relations
BBOT
Investors@BBOTx.com

Media Contact:
Jake Robison
Inizio Evoke Comms
Jake.robison@inizioevoke.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does FDA Fast Track designation mean for BBOT's BBO-11818 (BBOT) treatment?

Fast Track designation expedites development and review for serious conditions with unmet need. According to the company, it enables more frequent FDA interactions and potential rolling review to accelerate BBO-11818's pathway toward approval.

What clinical evidence supports BBO-11818's Fast Track status for BBOT (BBOT)?

Early clinical data showed a confirmed partial response in pancreatic cancer and tumor reductions across doses. According to the company, preliminary January 2026 results demonstrated antitumor activity and a differentiated safety profile in dose escalation.

What is the development stage and timeline for BBOT's BBO-11818 (BBOT)?

BBO-11818 is in a Phase 1 trial evaluating monotherapy and combinations. According to the company, updated Phase 1 clinical data are expected in the second half of 2026, informing next development steps.

Which KRAS mutations is BBO-11818 designed to target for BBOT (BBOT)?

BBO-11818 is designed as a pan-KRAS inhibitor targeting multiple KRAS mutations beyond G12C. According to the company, it aims to address mutations like KRASG12D and KRASG12V with strong KRAS binding and selectivity.

Will BBO-11818 be tested with other therapies by BBOT (BBOT)?

Yes, BBO-11818 is being evaluated as monotherapy and in combination with standard therapies and BBOT's RAS:PI3Kα breaker. According to the company, combination studies are part of the Phase 1 KONQUER-101 trial design.

How does the Fast Track affect patient access and regulatory review for BBOT's BBO-11818 (BBOT)?

Fast Track can streamline interactions and possibly speed review but does not guarantee approval. According to the company, the designation is intended to accelerate development and FDA review for this serious unmet need.