Business Wire India

Boomi, the data activation company for AI, today announced it has signed a letter of intent to acquire Lunar.dev, an innovator in AI and MCP gateway. The proposed acquisition is expected to enrich the Boomi Enterprise Platform and Boomi Connect with advanced capabilities to govern and scale AI usage across enterprise systems.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513850557/en/

 

 

 

As organizations move from AI experimentation to production, controlling how agents and AI applications interact with LLMs at scale has become critical. Lunar.dev addresses this need with an AI gateway that delivers granular, policy-driven control over AI interactions, with the visibility, security, and performance required for enterprise environments. These capabilities enable organizations to move from pilot to production with confidence, ensuring AI operates reliably, securely, and within defined guardrails.

 

“At Boomi, we see a clear shift from AI experimentation to real-world deployment,” said Steve Lucas, Chairman and CEO of Boomi. “Our intent to acquire Lunar.dev is focused on one priority: giving customers control over every interaction between AI, data, and applications. That’s essential to building trust and scaling AI with confidence.”

 

 

Strengthening AI Governance and Control

 

 

With Lunar.dev, Boomi will introduce a centralized and decentralized control layer for managing AI interactions across the enterprise. This enables organizations to:

 

 

• Enforce fine-grained policy and governance across every AI interaction
• Secure and precisely control AI access to enterprise data and systems
• Achieve full observability into AI activity, including prompts, responses, and downstream actions
• Operate AI at scale with high-performance routing and execution
• Deploy with flexibility, including full tenant control across on-premises, private cloud, and sovereign environments

 

Expanding Boomi Connect with Governed Agent Connectivity

 

Lunar.dev is expected to become a key component of Boomi Connect, extending Boomi’s ability to enable secure, governed connectivity between AI tools (e.g. Claude, Copilot, Gemini) and enterprise applications through 1000+ managed, MCP-enabled tools. With Lunar.dev, Boomi will add a MCP gateway that additionally provides:

 

 

• Cost management and observability
• Scalable AI connectivity across hybrid and multi-cloud environments

 

Together with the Boomi MCP Registry, organizations can discover, govern, and manage AI services through a centralized catalog across Boomi and third-party environments.

 

These capabilities establish Boomi Connect as a unified foundation for governed agent connectivity, enabling organizations to scale AI securely across the enterprise.

 

 

Supporting the Next Phase of Agentic AI

 

 

This move reflects Boomi’s vision for the agentic enterprise: moving beyond fragmented tools toward a unified platform for connectivity, automation, and governance.

 

 

“This is about helping customers turn AI into a trusted, operational capability,” Lucas added. “With governance embedded at every layer, organizations can move faster while staying in control.”

 

 

Boomi World

 

 

Join the Boomi World keynotes live in Chicago on LinkedIn to hear the latest from Boomi executives, customers, and partners:

 

 

• #BoomiWorld 2026 Day 1 — Wednesday, May 13, 9 a.m. Central
• #BoomiWorld 2026 Live: Day 2 — Thursday, May 14, 9 a.m. Central

 

Learn more about Boomi World

 

• Learn more about Boomi World
• See all of Boomi’s announcements this week in the Boomi Newsroom
• Follow official event hashtag #BoomiWorld for event coverage on LinkedIn, X, and Instagram

 

About Boomi

 

Boomi, the data activation company for AI, powers the agentic enterprise by bringing data to life across the business. The Boomi Enterprise Platform is the active data foundation that delivers essential agentic infrastructure to drive agentic transformation. By unifying agent design and governance, API and MCP management, integration and automation, and data management into a single platform, Boomi enables organizations to harness the power of AI with secure, scalable connectivity. Trusted by over 30,000 customers and supported by a network of 800+ partners, Boomi helps organizations of all sizes achieve agility, efficiency, and innovation at scale. Discover more at boomi.com.

 

 

© 2026 Boomi, LP. Boomi, the ‘B’ logo, and Boomiverse are trademarks of Boomi, LP or its subsidiaries or affiliates. All rights reserved. Other names or marks may be the trademarks of their respective owners.

 

 

 

 

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Business Wire India

 

BEQALZI is a foundational BCL2 inhibitor designed for greater potency and selectivity, with potential to improve efficacy, tolerability, and convenience versus others in the class

 

Approval of BEQALZI marks the first new BCL2 inhibitor approved in a decade in the U.S. and the only BCL2 inhibitor approved in MCL, aiming to set a new standard of innovation

 

BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced 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.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513542161/en/

 

 

 

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 67^th American Society of Hematology (ASH) 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) 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.

 

 

About BeOne

 

 

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before.

 

 

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

 

 

Forward-Looking Statement

 

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential benefits of sonrotoclax; BeOne’s expectations regarding sonrotoclax’s clinical development, regulatory milestones, submissions and approvals; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent periodic report, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

 

 

To access BeOne media resources, please visit our Newsroom.

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260513542161/en/

 

Business Wire India

Kioxia Corporation today announced the KIOXIA XG10 Series solid state drives (SSDs), its latest high-performance client storage solution engineered for PC OEMs. Targeting the performance segment, the new KIOXIA XG10 Series leverages PCIe^® 5.0 technology to significantly elevate speed and responsiveness across data-intensive client applications.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513852514/en/

 

 

 

Designed as the successor to the KIOXIA XG8 Series, the KIOXIA XG10 Series adopts PCIe^® 5.0 interface, enabling improvements in both sequential and random performance. Compared to the previous generation⁽¹⁾, the new drives achieve up to 2x sequential read, more than 2x sequential write, and increases of approximately 122 % in random read and 158 % in random write performance – supporting faster data access and improved system responsiveness.

 

The KIOXIA XG10 Series is engineered to meet the needs of high-performance client system environments. These include professional applications, private AI training and inference, content creation and editing workflows, and immersive gaming experiences. With sequential read speeds of up to 14,000 MB/s and sequential write speeds reaching up to 12,000 MB/s, along with random read performance of up to 2,000 KIOPS and random write performance up to 1,600 KIOPS, the KIOXIA XG10 Series enables high-throughput performance for modern computing demands.

 

 

Additional features include:

 

 

• PCIe^® 5.0 (Gen5 x4) and NVMe™ 2.0d compliant
• Self-Encrypting Drive (SED) support based on TCG Opal version 2.02
• Recommended for high-performance PC systems including AI PCs, workstations and gaming platforms
• M.2 Type 2280 form factor
• Capacities of 512 GB, 1024 GB, 2048 GB, and 4096 GB⁽²⁾

 

The KIOXIA XG10 Series is currently sampling to select PC OEM customers, with PC shipments equipped with the SSD expected to begin from the second quarter of 2026 onwards.

 

Notes:
(1)	Compared to KIOXIA XG8 Series SSDs
(2)	KIOXIA XG10 Series 512 GB, 1024 GB models utilize BiCS FLASH™ generation 6 TLC-based flash memory, 2048 GB, 4096 GB models utilize BiCS FLASH™ generation 8 TLC-based flash memory.

 

– Definition of SSD capacity: Kioxia Corporation defines a kilobyte (KB) as 1,000 bytes, a megabyte (MB) as 1,000,000 bytes, a gigabyte (GB) as 1,000,000,000 bytes, a terabyte (TB) as 1,000,000,000,000 bytes, and a kibibyte (KiB) is 1,024 bytes. A computer operating system, however, reports storage capacity using powers of 2 for the definition of 1GB = 2^30 bytes = 1,073,741,824 bytes and 1TB = 2^40 bytes = 1,099,511,627,776 bytes and therefore shows less storage capacity. Available storage capacity (including examples of various media files) will vary based on file size, formatting, settings, software and operating system, and/or pre-installed software applications, or media content. Actual formatted capacity may vary.

 

– Read and write speed may vary depending on the host device, read and write conditions, and file size.

 

 

– IOPS: Input Output Per Second (or the number of I/O operations per second)

 

 

– Availability of the SED model lineup may vary by region

 

 

– NVMe is a registered or unregistered mark of NVM Express, Inc. in the United States and other countries.

 

 

– PCIe is a registered trademark of PCI-SIG.

 

 

– Other company names, product names and service names may be trademarks of third-party companies.

 

 

About Kioxia
Kioxia is a world leader in memory solutions, dedicated to the development, production and sale of flash memory and solid-state drives (SSDs). In April 2017, its predecessor Toshiba Memory was spun off from Toshiba Corporation, the company that invented NAND flash memory in 1987. Kioxia is committed to uplifting the world with “memory” by offering products, services and systems that create choice for customers and memory-based value for society. Kioxia’s innovative 3D flash memory technology, BiCS FLASH™, is shaping the future of storage in high-density applications, including advanced smartphones, PCs, automotive systems, data centers and generative AI systems.

 

 

*Information in this document, including product prices and specifications, content of services and contact information, is correct on the date of the announcement but is subject to change without prior notice.

 

 

Customer Inquiries:
Global Sales Offices
https://www.kioxia.com/en-jp/business/buy/global-sales.html

 

 

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260513852514/en/

 

Business Wire India

Sky Blue Cinematix is pleased to announce its appointment by UAE-based Aspin Holding as an Associate in relation to the FC Barcelona area for a range of high-profile commercial activities and brand integrations associated with FC Barcelona (Barça) within the Republic of India.

 

Under this landmark agreement, Sky Blue Cinematix serves as the authorised representative for Aspin Holding, tasked with supporting the promotion and market engagement of the club’s prestigious brand in the Indian market in connection with “the Project” through a diverse portfolio of integrated lifestyle and commercial entities.

 

A Visionary Strategic Collaboration

 

The appointment establishes a robust framework for collaboration, reflecting a shared commitment to supporting the development of the FC Barcelona brand. Acting in the strategic, Sky support capacity, Sky Blue Cinematix will contribute to brand positioning and the marketing of the Barça lifestyle, ensuring all initiatives meet the premium global standards of both Aspin Holding and FC Barcelona.

 

“We are delighted to collaborate with Aspin Holding to support this landmark Project in India,” said Dato’ Manikandamurthy Velayoudam, Chairman of Sky Blue Cinematix. “This collaboration is about more than just business; it is about connecting a world-class brand identity with one of the world’s most dynamic markets.”

 

Broadening the Commercial Horizon

 

The mandate covers a defined commercial scope, allowing Sky Blue Cinematix to explore and facilitate various branded experiences in connection with the Project. The partnership is set to introduce the passion of Barça to the Indian audience in connection with the Project through several key avenues.