On May 13, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the first quarter ended March 31, 2026.

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"Adicet is approaching a key inflection point as we prepare to report Phase 1 data for prula-cel in mid-year 2026, including data from at least 20 LN and SLE patients with a minimum of six months of follow-up," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "Reaching this important inflection point builds on the collaboration of our employees and a global network of investigators and clinical sites advancing a comprehensive Phase 1 trial of a potential first-in-class gamma delta 1 CAR-T cell therapy in autoimmune diseases."

Mr. Schor continued, "In parallel, we are continuing to build our portfolio with ADI-212, a gene-edited and armored product candidate designed to enhance clinical activity in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. We are also advancing our ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies."

First Quarter 2026 and Recent Operational Highlights:

Autoimmune diseases

Phase 1 prula-cel clinical update in LN and SLE patients anticipated in mid-2026. The Company plans to provide its next clinical update in mid-2026 for its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune conditions. Adicet also intends to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate start up activities for a pivotal program in LN or LN and SLE patients in the second half of 2026. In addition, following alignment with the FDA in November 2025, LN and SLE patients in the ongoing Phase 1 study and future studies may be dosed with prula-cel in the outpatient setting. The Company plans to provide a clinical update in patients with systemic sclerosis in the second half of 2026.
Ongoing Phase 1 trial of prula-cel in treatment-refractory rheumatoid arthritis (RA) to assess reduced conditioning regimens. The Phase 1 trial of prula-cel in RA is designed to assess two lymphodepletion approaches, cyclophosphamide alone and in combination with fludarabine. Primary objectives include evaluating safety and tolerability, with secondary assessments focused on cellular kinetics, pharmacodynamic markers, and disease activity measures. The next update on this trial is expected in the second half of 2026.
Solid tumor indications

Regulatory submission for ADI-212 planned for the third quarter of 2026 with Phase 1 start anticipated in the fourth quarter of 2026 pending regulatory clearance. Adicet continues to advance its next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor specific recognition. It integrates membrane tethered IL-12 armoring, and CRISPR/Cas9-mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with initiation of Phase 1 enrollment anticipated in the fourth quarter of 2026, subject to regulatory clearance.
Additional early-stage programs (CAR and other technologies)

Advancing innovation through a differentiated cell therapy platform. Adicet’s pipeline also includes additional early-stage gamma delta CAR-T cell therapy programs for autoimmune diseases, hematological malignancies and solid tumors. Additionally, Adicet has ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies.
Financial Results for First Quarter 2026:

Three months ended March 31, 2026

Research and Development (R&D) Expenses: R&D expenses were $17.5 million for the three months ended March 31, 2026, compared to $22.8 million during the same period in 2025. The decrease in R&D expenses was primarily due to a $3.6 million decrease in payroll and personnel expenses due to lower headcount, a $1.4 million decrease in expenses related to lab supplies and materials, a $0.5 million decrease related to lower CRO expenses and a $0.2 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.4 million increase in professional fees.
General and Administrative (G&A) Expenses: G&A expenses were $4.1 million for the three months ended March 31, 2026, compared to $7.1 million during the same period in 2025. The decrease in G&A expenses was due to a $1.4 million decrease in payroll and personnel-related expenses primarily due to a decrease in stock-based compensation and lower headcount, a $1.0 million decrease in allocated facility-related expenses and a $0.6 million decrease in professional fees.
Net Loss: Net loss for the three months ended March 31, 2026 was $20.2 million, or a net loss of $1.88 per basic and diluted share, including non-cash stock-based compensation expense of $1.3 million, as compared to a net loss of $28.2 million, or a net loss of $4.96 per basic and diluted share, including non-cash stock-based compensation expense of $3.2 million during the same period in 2025.
Cash Position: Cash, cash equivalents and short-term investments were $137.6 million as of March 31, 2026, compared to $158.5 million as of December 31, 2025. The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2026, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, MAY 13, 2026, View Source [SID1234665655])

On May 13, 2026 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the fiscal year 2025 (period ended March 31, 2026). The Company delivered solid results in line with its latest FY2025 Management Guidance, reflecting strong OPEX savings, mitigating revenue headwinds while continuing to invest in future growth.

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Key Highlights for FY2025

Revenue decreased by 1.7% YoY at actual exchange rates (AER), resulting from the loss of exclusivity for VYVANSE which was partially mitigated by Growth and Launch Products. On a Core basis, Revenue decreased by 2.6% at Constant Exchange Rate (CER).
Core Operating Profit increased by 0.8% YoY at AER and declined by 0.9% at CER, protected by OPEX savings, while still investing for growth.
Reported Operating Profit increased by 19.3% YoY at AER, also reflecting a step-down in amortization expenses for VYVANSE and lower restructuring expenses.
Core EPS increased by 5.2% YoY at AER and by 3.1% at CER, while reported EPS increased by 78.1% YoY.
Adjusted Free Cash Flow amounted to JPY 684.5 billion, in line with forecast, and the Company ended fiscal year with strong cash balance.
Delivered key milestones for oveporexton, rusfertide, and zasocitinib, with positive Phase 3 readouts; completed regulatory submissions for oveporexton and rusfertide, and launch preparations underway.
Takeda Chief Executive Officer (CEO)-elect, Julie Kim, commented:
"FY2025 was a pivotal year, validating the strength of our execution against demanding development and regulatory milestones, the resilience of our commercial portfolio and our strong position with three major launches planned in the next 12 months and the most robust late-stage pipeline in our history. Our growth roadmap is built around two strategic horizons: transforming for growth through near-term launches and strengthening competitiveness and accelerating growth by transitioning to a new cohort of blockbuster brands, together positioning us for long-term profitable growth and patient impact."

Takeda Chief Financial Officer, Milano Furuta, commented:
"In FY2025, despite topline headwinds, we delivered solid profit and cash flow through disciplined cost control, while directing growth investment toward new product launches and the pipeline. In FY2026, we will continue to focus on transforming operations and protecting profitability while delivering successful launches and advancing our pipeline. Strong cash flow generation and deleveraging will support long-term investment for growth acceleration and ensure competitive returns for our shareholders."

Full-year FY2026 Forecast and Guidance
Based on the current business outlook and planned investment profile, Takeda issued the following FY2026 forecast and management guidance.

(Billion yen, except percentages and per share amounts)

Item

FY2026
FORECAST

FY2026

MANAGEMENT GUIDANCE

Core Change at CER

(Non-IFRS)

Revenue

4,640.0

—

Core Revenue (Non-IFRS)

4,640.0

Low- single digit % decline

Operating Profit

420.0

—

Core Operating Profit (Non-IFRS)

1,160.0

5% ~ 8% decline

Net Profit

166.0

—

EPS (Yen)

104

—

Core EPS (Yen (Non-IFRS)

472

Mid-teens % decline

Adjusted Free Cash Flow (Non-IFRS)

650.0-750.0

—

Annual Dividend per Share (Yen)

204

—

Pipeline Achievements Set the Stage for Future Growth
Our three leading late-stage assets are positioned for regulatory approvals in the U.S. and other geographies in FY2026-2027. We expect this will be a pivotal period for launches and investment with clear near-term wins and proof points over the next 12–24 months.

oveporexton:

Oveporexton is potentially a first-of-its-kind orexin agonist designed to address the underlying orexin deficiency that causes narcolepsy type 1.
Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for oveporexton in the second half of 2026 and has also completed regulatory filings in Japan and China.
rusfertide:

Rusfertide is a potential first‑in‑class hepcidin mimetic that has demonstrated rapid, stable, and durable hematocrit control in patients with polycythemia vera, or PV, and has the potential to shift the standard of care in this blood cancer.
Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for rusfertide in the second half of 2026.
zasocitinib:

Zasocitinib is poised to be a leading oral treatment option for psoriasis patients with the potential to significantly expand the oral segment in a growing psoriasis market.
Takeda is making decisive investments to support a planned regulatory filing in 2026 and a commercial launch in the first half of 2027.
FINANCIAL HIGHLIGHTS for FY2025 Ended March 31, 2026

(Billion yen, except percentages and per share amounts)

Item

FY2025

(Billion JPY)

FY2024

(Billion JPY)

YoY Growth

(AER)

Revenue

4,505.7

4,581.6

-1.7%

Operating Profit

408.8

342.6

+19.3%

Margin

9.1%

7.5%

+1.6pp

Net Profit

191.8

107.9

+77.7%

EPS (Yen)

122

68

+78.1%

Operating Cash Flow

1,041.4

1057.2

-1.5%

Adjusted Free Cash
Flow (Non-IFRS)

684.5

769.0

-11.0%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

Item

FY2025

(Billion JPY)

FY2024

(Billion JPY)

YoY Growth

(AER)

YoY Growth

(CER)

Revenue

4,505.7

4,579.8

-1.6%

-2.6%

Operating Profit

1,172.5

1,162.6

+0.8%

-0.9%

Margin

26.0%

25.4%

+0.6pp

—

Net Profit

814.1

775.6

+5.0%

+2.9%

EPS (Yen)

517

491

+5.2%

+3.1%

Capital Allocation and Shareholder Returns
Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation to drive growth and enables the company to deliver returns to shareholders under its progressive dividend policy. In FY2025, the proposed annual dividend was JPY 200 per share, and year-end adjusted net debt/adjusted EBITDA was 2.6x.

Additional Information About Takeda’s FY2025 Results
Takeda will host a conference call for investors and analysts on Wednesday, May 13, 2026, at 7:00 PM JST / 6:00 AM EDT to discuss its full-year 2025 financial results.

A live webcast of the conference call, along with presentation materials, will be available on the investor relations section of Takeda’s website at www.takeda.com/investors. The presentation will contain further details on Takeda’s FY2025 results, commercial progress, pipeline updates, and other financial information, including key assumptions for the FY2026 forecast and definitions of non-IFRS measures.

(Press release, Takeda, MAY 13, 2026, View Source [SID1234665654])

On May 13, 2026 Assertio Holdings, Inc. (Nasdaq: ASRT) ("Assertio" or the "Company") reported that, following an engagement process outlined under the revised merger agreement (the "Garda Merger Agreement") with Garda Therapeutics, Inc. ("Garda"), the Company’s Board of Directors (the "Board") approved a definitive agreement with Zydus Worldwide DMCC, a subsidiary of Zydus Lifesciences Limited ("Zydus") to acquire all outstanding shares of Assertio common stock for $23.50 per share in cash, representing total consideration of approximately $166.4 million (the "Zydus Offer"). The Board determined that the Zydus Offer constituted a "Superior Proposal" under the Garda Merger Agreement and authorized the Company to terminate the Garda agreement announced on May 4, 2026 and enter into the transaction with Zydus (the "Zydus Transaction").

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The Zydus Offer of $23.50 per share in cash represents a 30.6% premium to the $18.00 per share all-cash transaction with Garda announced on April 8, 2026, a 7.8% premium to the $21.80 per share all-cash transaction with Garda announced on May 4, 2026, and a 75.8% premium to the Company’s unaffected closing stock price on March 20, 2026 – the day before significant share price and trading volume movement.

In making its determination that the Zydus Offer represented a Superior Proposal, the Board considered Zydus’ strong execution profile, including that the Zydus Offer has no financing contingencies, requires no third-party financing, and is fully guaranteed by a creditworthy Zydus entity, providing Assertio with direct recourse in the event of a breach or failure to close.

Heather Mason, Chair of the Assertio Board of Directors, stated: "We are pleased that the comprehensive and disciplined strategic review process undertaken by the Board has yielded this outcome. After carefully evaluating all relevant factors, including price, certainty of value, execution risk and overall transaction terms, the Board determined that the Zydus offer represents the best path available to Assertio shareholders. I want to thank everyone involved for their continued dedication throughout this process."

Transaction Overview

Under the terms of the Zydus Transaction, Zydus will promptly commence a tender offer to acquire all outstanding shares of Assertio common stock for $23.50 per share in cash, without interest, representing total cash consideration of approximately $166.4 million. The Board unanimously recommends that Assertio stockholders tender their shares into the Zydus Transaction.

The Zydus Transaction is expected to close in the second quarter of 2026, subject to customary closing conditions, including the tender of a majority of the Company’s outstanding shares. No regulatory approvals are expected to be required.

Following the successful completion of the tender offer, Zydus will acquire any remaining shares through a second-step merger at the same price of $23.50 per share in cash. Upon completion of the transaction, Assertio’s common stock will no longer be listed on Nasdaq.

Assertio will file a current report on Form 8-K with the U.S. Securities and Exchange Commission (the "SEC") containing a summary of the terms and conditions of the Zydus Transaction. The Company also expects to file a Schedule 14D-9 with the SEC in connection with the tender offer, which will include additional information regarding the transaction and the strategic review process.

Advisors

Moelis & Company LLC is serving as financial advisor, Gibson, Dunn & Crutcher LLP as legal counsel, and Longacre Square Partners as strategy and communications advisor to Assertio.

(Press release, Assertio Holdings, MAY 13, 2026, View Source [SID1234665653])

On May 13, 2026 AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, reported two-year results from the PRESERVE pivotal trial (NCT04972097) demonstrating durable oncologic control and a sustained safety profile for the NanoKnife System in the focal ablation of intermediate-risk prostate cancer. The data will be discussed by Izak Faiena, M.D., of Columbia University at the 2026 American Urological Association (AUA) Annual Meeting on Sunday, May 17 in Washington, D.C.

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The PRESERVE trial is a prospective, single-arm pivotal IDE study evaluating focal irreversible electroporation (IRE) using the NanoKnife System in 121 patients with Gleason Grade Group 2–3 intermediate-risk prostate cancer, conducted across 17 U.S. clinical centers in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). Primary 12-month results, published in European Urology in July 2025, demonstrated an 80% freedom-from-treatment-failure rate among protocol-biopsied patients.1

At 24 months, the updated findings confirm durability of outcomes:

94.4% of analysis-eligible patients (68 of 72) completed the 24-month assessment, reflecting strong cohort retention
No new treatment failures were identified among patients with available follow-up at 24 months
One patient (1.5%) underwent a clinically indicated biopsy, which was negative for any cancer
97% of patients (66 of 68) had a PSA at 24 months below their baseline value
No new device- or procedure-related adverse events were reported between the 12- and 24-month assessments
The 24-month PRESERVE data complement an international long-term evidence base for focal IRE, including median five-year outcomes from a 2023 international multi-institutional cohort demonstrating sustained oncologic control and preservation of functional outcomes.2

PRESERVE Trial — 24-Month Results Summary

Focal IRE Ablation Using the NanoKnife System for Intermediate-Risk Prostate Cancer

Study Design

Parameter

Detail

Trial Name

PRESERVE (NCT04972097)

Study Type

Prospective, single-arm, pivotal IDE study

Technology

NanoKnife System — Focal Irreversible Electroporation (IRE)

Population

Gleason Grade Group 2–3 (Gleason 3+4 or 4+3), clinical stage ≤T2c intermediate-risk prostate cancer

Sites

17 U.S. clinical centers

Partner

Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC)

Sponsor

AngioDynamics, Inc.

Key 24-Month Results

Endpoint

Result

Total Enrolled

121 patients

24-Month Analysis-Eligible

72 patients

24-Month Completers

68 of 72 (94.4%)

New Treatment Failures (12–24 mo)

0

Clinically Triggered Biopsies

1 (negative for any cancer)

PSA Below Baseline at 24 Months

66 of 68 (97%)

New Device/Procedure-Related AEs (12–24 mo)

0

12-Month Primary Endpoint (Reference)

Endpoint

Result

Freedom from Treatment Failure

80% among protocol-biopsied patients

Publication

European Urology, July 2025 (George et al.)

"Two years of prospective pivotal data in the United States, combined with more than five years of international follow-up evidence, paints a coherent and compelling picture of sustained efficacy," said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. "These results reinforce that the NanoKnife System is a clinically meaningful focal therapy option that physicians across care settings are actively incorporating into practice."

With a growing body of prospective U.S. pivotal data and long-term international evidence supporting the safety and efficacy of focal IRE, the NanoKnife System continues to gain traction as a meaningful treatment option for men with intermediate-risk prostate cancer who seek durable oncologic control while preserving quality of life. AngioDynamics is advancing the NanoKnife IRE System evidence base and the reimbursement infrastructure needed to bring this option to more patients and physicians across care settings.

(Press release, AngioDynamics, MAY 13, 2026, View Source [SID1234665652])

On May 13, 2026 BeOne Medicines Ltd. ("BeOne") (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BEQALZI was designed to enhance BCL2 inhibition—with greater potency, selectivity, and a pharmacologic profile with potential to improve efficacy, tolerability, and convenience over others in the class.

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Michael Wang, M.D., Global Principal Investigator, the Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, said:

"The data supporting the approval of sonrotoclax in the U.S. confirm its role as a foundational therapy for mantle cell lymphoma in the post-BTK inhibitor setting, and demonstrate that it can deliver robust disease control when treatment choices are limited and outcomes are poor. From a clinical perspective, this provides physicians with an important new option grounded in both efficacy and tolerability, fundamentally changing how we think about sequencing therapy in this disease."

Data supporting approval

The accelerated approval of BEQALZI is supported by efficacy and safety data from the Phase 1/2 study, BGB-11417-201 (NCT05471843), which was presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. The study included an independent review of efficacy data and demonstrated:

Overall response rate (ORR): 52% (95% CI, 42-62)
Complete response (CR) rate: 16% (95% CI, 9.1-24.0)
Median time to response (TTR): 1.9 months
Median duration of response (DOR): 15.8 months (95% CI, 7.4 months-NE) at a median response follow-up of 11.9 months (has yet to reach full maturity)
Safety: treatment with sonrotoclax monotherapy was generally well tolerated
Continued approval for this indication is contingent upon confirmation of clinical benefit in the confirmatory CELESTIAL-RRMCL trial (NCT06742996), which is underway. The U.S. FDA granted Breakthrough Therapy Designation (BTD) for sonrotoclax in this indication, as well as Fast Track Designation and Orphan Drug Designation.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:

"BeOne is leading the advancement and enhancement of BCL2 inhibition to revolutionize how we treat patients living with B-cell malignancies. Today’s approval of BEQALZI represents critical progress for patients with mantle cell lymphoma and reinforces our strategy of building foundational medicines designed to raise the standard of care in B-cell malignancies."

A new BCL2 option for a challenging R/R MCL post–BTK inhibitor setting

MCL is a rare and often aggressive subtype of non-Hodgkin lymphoma. In the United States, approximately 3,300 new cases of MCL are diagnosed each year.1 While many patients respond to initial therapy, relapse is common, and outcomes after progression can be poor, particularly after prior treatment with a BTK inhibitor. The accelerated approval of BEQALZI introduces a new targeted mechanism to the MCL treatment landscape and reinforces the importance of expanding therapeutic choices for patients as the disease evolves.

Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation, said:

"For people living with relapsed or refractory mantle cell lymphoma, each progression can bring uncertainty and questions regarding remaining treatment options. The FDA approval of sonrotoclax represents significant progress for the U.S. mantle cell lymphoma community, offering renewed hope for patients and families who have exhausted other available therapies. Advances like this underscore why continued research and innovation in this disease remain so critical."

Additional regulatory and development updates

BEQALZI is also approved in China for the treatment of R/R MCL, as well as adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor. Data from the Phase 1/2 study of sonrotoclax in R/R MCL is also under review by the European Medicines Agency and other regulatory agencies.

The U.S. FDA also granted sonrotoclax Fast Track Designation for Waldenström macroglobulinemia (WM), as well as Orphan Drug Designation for the treatment of adult patients with WM, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.

Additionally, sonrotoclax is currently being studied in combination with other therapeutics, including zanubrutinib, as a potential treatment for CLL, with updated data expected to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

About BEQALZI (sonrotoclax)

BEQALZI (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program.

INDICATION

BEQALZI (sonrotoclax) is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome (TLS).

WARNINGS & PRECAUTIONS

Tumor Lysis Syndrome (TLS): BEQALZI can cause rapid tumor reduction and changes in blood chemistries consistent with TLS, which may be serious or life-threatening and require prompt management. TLS may occur as early as 4 hours after the first dose, with dose increases, or upon reinitiation following treatment interruption. Laboratory or clinical TLS occurred in 7% of patients who followed the recommended dose ramp-up. Assess all patients for TLS risk and initiate prophylaxis, including adequate hydration and antihyperuricemics. For patients at high risk of TLS, consider hospitalization with intravenous hydration and employ frequent monitoring. Monitor blood chemistries closely and manage abnormalities promptly. Interrupt BEQALZI for TLS; upon reinitiation, follow dose modification guidance in the Prescribing Information.
Serious Infections: BEQALZI can cause fatal or serious infections. Serious infections occurred in 14% of patients; Grade 3-4 occurred in 17% (fatal: 2.6%). The most common Grade 3 or greater infection was pneumonia (10%). Monitor for signs and symptoms of infection and treat appropriately. Consider prophylactic antimicrobials and immunoglobulins. Interrupt, reduce dose, or permanently discontinue BEQALZI based on severity.
Neutropenia: BEQALZI can cause serious or severe cytopenias, including neutropenia. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%); febrile neutropenia occurred in 1.7% of all patients. Monitor complete blood counts throughout treatment. Interrupt treatment, reduce the dose, or permanently discontinue BEQALZI based on severity.
Embryo-Fetal Toxicity: BEQALZI can cause fetal harm when administered to pregnant women. Advise patients of the potential risk to a fetus. Verify pregnancy status prior to initiation. Advise females to use effective contraception and males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.
ADVERSE REACTIONS

The most common adverse reactions (≥15%) are pneumonia (16%) and fatigue (16%). The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes (29%) and neutrophils (18%).

DRUG INTERACTIONS

Strong or Moderate CYP3A Inhibitors: Concomitant use increases BEQALZI exposure. Avoid use of strong CYP3A inhibitors during BEQALZI initiation and ramp-up. Avoid use of moderate CYP3A inhibitors at the 1 mg and 2 mg doses; for all other doses, reduce the BEQALZI dose with concomitant use. See approved labeling for dose modifications.
Strong or Moderate CYP3A Inducers: Concomitant use decreases BEQALZI exposure. Avoid use.
SPECIAL POPULATIONS

Lactation: Advise women not to breastfeed during treatment with BEQALZI and for 1 week after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full U.S. Prescribing Information.

(Press release, BeOne Medicines, MAY 13, 2026, View Source [SID1234665651])