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BriaCell Adds NYU Langone Health’s Perlmutter Cancer Center as Clinical Site in Pivotal Phase 3 Breast Cancer Study

(Moderate)
(Very Positive)

BriaCell (Nasdaq: BCTX) added NYU Langone Health’s Laura and Isaac Perlmutter Cancer Center as a clinical site in its pivotal Phase 3 Bria-ABC study for advanced metastatic breast cancer. The trial evaluates Bria-IMT plus an immune checkpoint inhibitor versus physician’s choice, with overall survival as the primary endpoint and an interim analysis planned after 144 patient events. Bria-IMT has received FDA Fast Track designation. ClinicalTrials.gov identifier: NCT06072612.

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Positive

  • Added NYU Langone Perlmutter as a Phase 3 clinical site
  • Bria-IMT has FDA Fast Track designation
  • Interim analysis planned after 144 patient events (clear trigger)

Negative

  • Interim analysis requires 144 deaths to occur before readout
  • No interim efficacy or survival results disclosed yet

News Market Reaction – BCTX

-1.20%
-1.20% Session close to close

In the May 7 session, BCTX declined 1.20%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement adds NYU Langone’s Perlmutter Cancer Center as a site in BriaCell’s pivotal Phase ...
Analysis

This announcement adds NYU Langone’s Perlmutter Cancer Center as a site in BriaCell’s pivotal Phase 3 Bria‑ABC trial, with interim analysis planned after 144 patient events and overall survival as the primary endpoint. The regimen holds FDA Fast Track status, extending a series of clinical updates and conference data. Investors may watch enrollment progress, timing of interim results, and future regulatory disclosures to gauge how the program advances from here.

Key Figures

Trial phase: Pivotal Phase 3 Interim analysis trigger: 144 patient events Clinical trials highlighted: Eleven trials +1 more
4 metrics
Trial phase Pivotal Phase 3 Bria-ABC advanced metastatic breast cancer study
Interim analysis trigger 144 patient events Deaths required before Phase 3 interim analysis
Clinical trials highlighted Eleven trials Nature Medicine feature on 2026-shaping clinical trials
Fast Track FDA Fast Track designation Granted to Bria-IMT combination regimen

Previous Clinical trial Reports

5 past events · Latest: Apr 27 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Apr 27 ASCO data plans Positive +3.9% Announced six Bria-IMT metastatic breast cancer data presentations at ASCO 2026.
Apr 20 AACR QOL/biomarkers Positive -9.3% Reported preserved quality of life and promising biomarker signals in Phase 3/2 studies.
Dec 18 Nature Medicine feature Positive +3.2% Phase 3 Bria-IMT trial named among 2026-shaping studies in Nature Medicine article.
Dec 10 SABCS Phase 2/3 data Positive -7.9% Shared Phase 2 survival and Phase 3 safety/biomarker data at SABCS 2025.
Dec 09 Phase 3 enrollment Positive -2.1% Confirmed Phase 3 enrollment on track with interim OS analysis planned upon 144 events.

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

Pattern Detected

Clinical-trial headlines for Bria-IMT/Bria-ABC often generate mixed or negative next-day moves despite generally positive clinical messaging, with more divergences than alignments.

Recent Company History

Over the last few months, BriaCell has repeatedly highlighted progress in its Bria‑IMT pivotal Phase 3 program and related platforms. Clinical‑trial news on Dec 9–18, 2025 covered enrollment progress, Nature Medicine recognition, and Phase 2/3 data, yet price reactions were often negative. More recent clinical updates in April 2026 around AACR and ASCO presentations again showed mixed stock responses. Today’s addition of a major NYU site extends that ongoing Phase 3 execution story.

Key Terms

pivotal phase 3, immune check point inhibitor, overall survival (os), fast track designation, +1 more
5 terms
pivotal phase 3 medical
"as a clinical trial site in its ongoing pivotal Phase 3 clinical study (Bria-ABC)."
A pivotal Phase 3 is a large, final clinical trial designed to show whether a new treatment actually works and is safe enough for regulatory approval. Think of it as the product’s final exam or full dress rehearsal: positive results are the main evidence regulators use to decide if the drug can be sold, while negative or ambiguous results can halt approval and value. Investors watch these trials closely because their outcomes strongly affect a company’s future sales prospects, regulatory risk, and stock value.
immune check point inhibitor medical
"Bria-IMT™, plus an immune check point inhibitor versus treatment of physician’s choice"
A drug that lifts the natural “brakes” the body uses to keep the immune system from attacking healthy cells, allowing immune cells to recognize and destroy cancer cells. Think of it as removing restraints on security guards so they can chase down intruders; success or failure in clinical trials, approvals, and patient use can quickly change a drugmaker’s revenue prospects and therefore its stock value.
overall survival (os) medical
"Interim analysis ... after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint."
Overall survival (OS) is the length of time from the start of a treatment or clinical study until death from any cause, essentially measuring how long patients live after a therapy begins. Investors watch OS because it is the most direct evidence a treatment extends life; stronger OS results can drive regulatory approvals, wider use and higher revenue expectations, much like sales figures proving a product actually works.
fast track designation regulatory
"the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential"
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.
clinicaltrials.gov regulatory
"For additional information ... please visit ClinicalTrials.gov NCT06072612."
clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

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

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PHILADELPHIA and VANCOUVER, British Columbia, May 07, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care is pleased to announce the addition of NYU Langone Health’s Laura and Isaac Perlmutter Cancer Center, a renowned cancer center in New York City, as a clinical trial site in its ongoing pivotal Phase 3 clinical study (Bria-ABC).

BriaCell has enjoyed a marked uptick in interest from premier cancer centers and patient enrollment numbers following the prominent independent feature of its Phase 3 clinical trial in Nature Medicine’s publication, “Eleven clinical trials that will shape medicine in 2026”, linked here.

BriaCell’s pivotal Phase 3 clinical study in Advanced Breast Cancer (Bria-ABC) is evaluating BriaCell’s lead clinical candidate, Bria-IMT™, plus an immune check point inhibitor versus treatment of physician’s choice in advanced metastatic breast cancer.

“At NYU Langone Health’s Perlmutter Cancer Center, we are dedicated to offering state-of-the-art treatments to patients with difficult-to-treat cancers,” stated Nancy Chan MD, Director, Breast Cancer Clinical Research, NYU Langone Health’s Perlmutter Cancer Center. “We look forward to helping accelerate the development of Bria-IMT, a novel immunotherapy with the potential to improve outcomes for patients with advanced metastatic breast cancer.”

“We are thrilled to partner with clinical experts at the renowned NYU Langone Health’s Perlmutter Cancer Center, a patient-focused, NCI-designated Comprehensive Cancer Center, to further expand patient access to our novel immunotherapy treatment,” said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We continue to advance the study and look forward to sharing interim data in the coming months.”

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer. Importantly, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612.

About BriaCell Therapeutics Corp.

BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.

Safe Harbor

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including those about the addition of a new clinical site in the ongoing pivotal Phase 3 clinical study of Bria‑IMT, and expectations regarding patient enrollment, interim analysis timing and the potential clinical benefits of the Bria‑IMT combination regimen, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements, such as those are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com

Investor Relations Contact:
investors@briacell.com


FAQ

What does BriaCell (BCTX) adding NYU Langone Perlmutter to the Phase 3 Bria-ABC study mean for the trial?

It expands site capacity and patient access for the Phase 3 Bria-ABC study, potentially aiding enrollment. According to the company, NYU Langone Perlmutter will serve as an additional clinical site to support patient recruitment and trial conduct for Bria-IMT combination therapy.

When will BriaCell (BCTX) perform the interim analysis for the Bria-ABC Phase 3 study?

The interim analysis will occur after 144 patient events (deaths) have occurred. According to the company, that event-driven analysis uses overall survival as the primary endpoint and will trigger the planned interim look at study data.

What is the primary endpoint of BriaCell's Bria-ABC Phase 3 trial (BCTX, NCT06072612)?

The primary endpoint is overall survival (OS) for patients with advanced metastatic breast cancer. According to the company, the study compares Bria-IMT plus a checkpoint inhibitor against physician’s choice with OS as the main efficacy measure.

What does FDA Fast Track designation for Bria-IMT mean for BriaCell (BCTX)?

Fast Track designation can expedite development and review processes for therapies addressing unmet needs. According to the company, Bria-IMT received FDA Fast Track for its potential to treat advanced metastatic breast cancer, which may enable more frequent FDA interactions.

How can patients find more information or enroll in BriaCell's Bria-ABC Phase 3 trial (BCTX)?

Patients and physicians can find trial details and site listings at ClinicalTrials.gov using identifier NCT06072612. According to the company, the listing provides eligibility criteria, participating sites, and contact information for enrollment inquiries.