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CG Oncology’s Presence at American Urological Association (AUA) Annual Meeting Underscores its Strong Commitment to NMIBC

On May 11, 2026 CG Oncology, Inc. (NASDAQ: CGON) reported its participation in the American Urological Association (AUA) 2026 Annual Meeting, taking place May 15–18, 2026, in Washington, D.C. CG Oncology will present first results from CORE-008 Cohort CX Phase 2 Trial evaluating intravesical combination therapy in High-Risk BCG-Exposed and BCG-Unresponsive patients and will be exhibiting at booth #3051. The AUA Annual Meeting is the largest global gathering of urologists and urologic professionals, showcasing the latest advances in urologic medicine, clinical research and patient care.

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First Results from CORE-008 Cohort CX
Title: Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec with Gemcitabine in Patients with High-Risk BCG-Exposed or BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Poster Presentation May 15, 2026, 3:30 – 5:30 PM ET
Podium Presentation at the SUO 2026 Annual Meeting at the AUA May 16, 2026, 4:25–4:30 PM ET
Additionally, the grant recipients of the annual CG-SUO-CTC NMIBC Research Fellowship will present their research at the SUO 2026 Annual Meeting at the AUA. This Fellowship is designed to support the development of outstanding clinical cancer research investigators who have demonstrated a commitment to improving the understanding and treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). Details of the presentations are below:

Grant Recipient Taylor A. Goodstein, MD Presents: Spatial Transcriptomic Profiling of the Tumor Microenvironment in BCG-Unresponsive NMIBC Patients Treated with Novel Intravesical Gene Therapies
May 16, 4:45 PM-4:50 PM ET
Grant Recipient Saum B. Ghodoussipour, MD Presents : Dynamic intra-tumor heterogeneity in non-muscle invasive bladder cancer
May 16, 4:50 PM-4:55 PM ET
Attendees of AUA 2026 are encouraged to visit CG Oncology at booth #3051 to learn more about the company’s clinical development program and its commitment to advancing innovative therapies for patients with bladder cancer.

(Press release, CG Oncology, MAY 11, 2026, View Source [SID1234665469])

Daiichi Sankyo Unveils New Five-Year Business Plan Focused on Oncology Leadership and Innovation

On May 11, 2026 Daiichi Sankyo (TSE: 4568) reported its next Five-Year Business Plan (FY2026 – FY2030) that outlines how the company plans to deliver more than 2.3 trillion yen in oncology revenue by 2030 and be a global top five oncology company by 2035 as part of its larger 2035 Vision to be recognized as a "trusted healthcare innovator transforming the lives of people through science and technology."

The new Five-Year Business Plan reinforces the enduring purpose of Daiichi Sankyo to contribute to the enrichment of quality of life around the world, and central to this growth strategy is an intensified focus on its mission to create new medicines for patients by leveraging the company’s expertise in science and technology.

"Our new five-year business plan represents a defining and transformative phase for Daiichi Sankyo," said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. "By leveraging our strengths in science and technology, particularly maximizing the value of our established DXd antibody drug conjugate platform and prioritizing our efforts to identify new breakthrough generating technologies, Daiichi Sankyo is committed to delivering innovative medicines to patients faster while driving sustainable growth and long-term value for all stakeholders."

Advancing Towards Global Top Five Oncology Company with Strong Financial Targets
A core ambition of the Five-Year Business Plan is to establish Daiichi Sankyo as a global top five oncology company by 2035 as measured by more than three trillion yen in FY2030 revenue, an increase from 2.1 trillion yen in FY2025 revenue, demonstrating aggressive growth. Operating profit of more than 600 billion yen is expected to be achieved by end of fiscal year 2030. Target earnings per share (EPS) is estimated to be more than 260 yen in FY2030 with an adjusted dividend on equity (DOE) of 10.0% or higher each year and progressive dividends. Operating profit is expected to reach one trillion yen in the early 2030s.

To achieve these financial targets, Daiichi Sankyo will maximize the value of its DXd antibody drug conjugate (ADC) portfolio and additional oncology pipeline through rapid market penetration of more than 20 new indications across five medicines by 2030, reaching more than 700,000 new patients annually by 2035.

During FY2026, there are five practice-changing launches planned across the DXd ADC portfolio in various countries/regions globally, including four new breast cancer indications for Enhertu and Datroway and the company’s first-ever launch in small cell lung cancer with ifinatamab deruxtecan (I-DXd).

"Enhertu has changed the classification and treatment of breast cancer, becoming the most successful antibody drug conjugate ever by revenue. Datroway, our second DXd antibody drug conjugate, is on its way to changing the treatment paradigm for triple negative breast cancer," said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. "By leveraging this extensive expertise, we plan to expand our leadership into lung cancer where there are more than 10 new indication launches planned for this tumor type across our portfolio over the next five years."

Accelerating Innovation Through Science and Technology
The DXd ADC platform has achieved strong clinical development with high early-phase success rates, and Daiichi Sankyo is advancing research behind new ADCs with novel cytotoxic and immunological payloads to build upon this industry-leading scientific expertise.

Daiichi Sankyo is further strengthening its R&D engine through a breakthrough generating technology (BGT) approach, a platform-based drug discovery model, designed to deliver innovative medicines to patients faster and with a higher probability of success. By 2030, Daiichi Sankyo aims to identify additional BGTs, which may consist of multi-specific antibodies, targeted protein degradation and siRNA.

"Enhertu was one of the fastest developed biologics in oncology," said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. "We aim to further accelerate the speed of development of our pipeline assets through increasing the efficiency of clinical development processes, including leveraging the latest digital and artificial intelligence tools as well as enhancing our biomarker capabilities for better patient selection strategies."

Driving Operational Excellence
A Business Transformation Function was established to drive company-wide operational excellence by enhancing productivity through AI and digital technologies and optimizing procurement processes, with the goal of achieving cost optimization and profit improvement of more than 200 billion yen by 2030. The company will centralize global commercialization activities to drive greater speed and consistency worldwide, while optimizing resources and investment decisions in line with global strategic priorities.

Contributing to Sustainable Society
Daiichi Sankyo reaffirms its commitment to being a trusted partner for a sustainable society, guided by meaningful engagement with diverse stakeholders, including patients, employees, the medical community and investors. The company will continue to attract specialized talent and foster a high-engagement culture that connects employees with patient voices, ensuring patients remain at the center of every decision. Trusted relationships with healthcare professionals will be strengthened by the creation of new standards of care through evidence generation while upholding the highest compliance standards.

On the environmental front, Daiichi Sankyo is targeting a 63% reduction in Scope 1 and 2 CO2 emissions versus 2015 levels, 100% renewable energy adoption and supplier alignment with 1.5-degree climate goals by 2030.

(Press release, Daiichi Sankyo, MAY 11, 2026, https://www.businesswire.com/news/home/20260510205619/en/Daiichi-Sankyo-Unveils-New-Five-Year-Business-Plan-Focused-on-Oncology-Leadership-and-Innovation [SID1234665468])

Zai Lab Receives U.S. FDA Fast Track Designation for Zocilurtatug Pelitecan (Zoci), a DLL3-Targeting ADC, for Treatment of Extrapulmonary Neuroendocrine Carcinomas (epNECs)

On May 11, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of extrapulmonary neuroendocrine carcinomas (epNECs) following progression after standard first-line therapy. epNECs are an aggressive malignancy affecting approximately 100,000 people worldwide, with no targeted therapies and no approved standard of care in previously treated disease.

"This is the second FDA Fast Track Designation for zoci, underscoring the significant potential of this investigational medication to provide an important new treatment option for patients with difficult-to-treat cancers that have few available therapies," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "This designation will support our efforts to advance this novel therapy through clinical development with both the speed and quality that define our approach. We are actively engaging with health authorities on a registrational plan for epNECs."

Zai Lab reported promising preliminary data from an ongoing registration-enabling multicenter, Phase 1b/2 clinical trial of zoci (NCT06885281) in patients with epNEC and other selected solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 last month. In heavily pretreated patients enrolled in the Phase 1b/2 study, zoci demonstrated encouraging antitumor activity, including an objective response rate (ORR) of 38.2%. Zoci also demonstrated a manageable safety profile—neutrophil count decrease was the only grade ≥3 treatment-related adverse event occurring in more than one patient.

Zai Lab received Fast Track designation for zoci for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in May 2025. Fast Track designation facilitates the expedited development and review of new drugs to address an unmet medical need or treat serious or life-threatening diseases. Benefits of this designation include more frequent engagements with the FDA to discuss the drug’s clinical development plan and eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci targets Delta-like ligand 3 (DLL3), a validated therapeutic target for small cell lung cancer (SCLC) that is overexpressed in many neuroendocrine carcinomas and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across second-line SCLC, first-line SCLC, and extrapulmonary neuroendocrine carcinoma (epNEC) by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential role as a new standard of care in previously treated extensive stage small cell lung cancer, as well as a backbone DLL3-targeting antibody drug conjugate (ADC) in first line combination regimens, including those that reduce the burdens of chemotherapy, such as check point inhibitors and T-cell engagers.

(Press release, Zai Laboratory, MAY 11, 2026, View Source [SID1234665467])

Therorna to Showcase Clinical-Ready Circular RNA in vivo CAR-T and CircRNA Pipeline at the 2026 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

On May 11, 2026 Therorna Inc., a clinical-stage biotechnology company pioneering circular RNA (circRNA)-based therapies, reported that the company will present three posters at the 2026 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place May 11–15, 2026, in Boston, Massachusetts. The lead presentation will showcase preclinical data supporting TI-0032, the company’s flagship CD19-targeted, circRNA-based in vivo CAR-T candidate, which recently advanced into a first-in-human investigator-initiated trial (IIT) in patients with recurrent and refractory autoimmune diseases. Two additional posters will feature data from Therorna’s broader pipeline: a circRNA-encoded CD19×CD3 T-cell engager and TI-0093, a circRNA-based HPV16 therapeutic cancer vaccine.

Therorna’s circRNA platform has been advanced into human studies across multiple programs and therapeutic areas. The company’s SARS-CoV-2 circRNA vaccine was evaluated in 100 healthy subjects. In oncology, Therorna’s TI-0093 HPV16 therapeutic vaccine received the first circRNA IND approval in oncology globally. Building on this clinical foundation, TI-0032 now extends Therorna’s circRNA platform into in vivo CAR-T therapy.

"The launch of the first-in-human study of TI-0032 is a defining milestone for Therorna and for our circRNA-based in vivo CAR-T program," said Lu Gao, Ph.D., Chief Executive Officer of Therorna. "TI-0032 is engineered to deliver re-dosable, off-the-shelf treatment by reprogramming a patient’s T cells in situ. Our preclinical data demonstrates highly potent and durable CAR expression, rapid and durable B-cell depletion at a very low dose in humanized mice, and complete B-cell depletion in non-human primates. With our US/China dual IND filing for TI-0032 on track, we are well positioned to bring a new class of in vivo CAR-T therapy to patients worldwide."

TI-0032: A Differentiated in vivo CAR-T Approach

TI-0032 is Therorna’s lead in vivo CAR-T candidate, designed to enable re-dosable, off-the-shelf treatment by reprogramming a patient’s T cells in situ. The product combines a CD19-directed CAR encoded on Therorna’s proprietary scarless, splint-free circRNA payload with a T cell–targeted lipid nanoparticle (tLNP) delivery system that uses a humanized antibody fragment for site-directed conjugation and an ionizable lipid that avoids hepatic accumulation. Preclinical highlights to be presented at ASGCT (Free ASGCT Whitepaper) include:

In primary human immune cells: durable CAR expression in primary human T cells (≥ 14 days), greater than 90% CD8⁺ selectivity in the CAR⁺ population, and >95% B-cell cytotoxicity at a ≥ 0.01 µg dose, including efficient B-cell depletion in PBMCs from SLE patients.
In humanized mouse models: robust in vivo CAR expression in CD8⁺ T cells across both the blood and tissues after a single dose; complete B-cell depletion within 24 hours; and complete tumor regression in the Nalm6 lymphoma model at 0.02 mg/kg (0.4 μg/mouse).
In non-human primates: complete B-cell depletion across peripheral blood, spleen, bone marrow, and mesenteric lymph nodes (IHC-confirmed).
Additional Pipeline Data to be Presented

Circular RNA-encoded CD19×CD3 T-cell engager (CircMab platform): A novel off-the-shelf approach designed to enable in-body production of a bispecific T-cell engager for deep B-cell depletion in autoimmune diseases, leveraging the durable protein expression of circRNA to extend exposure beyond what is achievable with conventional antibody infusions and with a potentially favorable cytokine release profile.
TI-0093 (CircVac platform): A circRNA-based HPV16 therapeutic vaccine, designed with an antigen architecture that balances T-helper support and CD8⁺ activation, eliciting potent tumor antigen–specific T-cell responses for the clearance of HPV16-positive solid tumors in vivo. TI-0093 has received the first circRNA IND approval in oncology globally.
Poster Presentation Details

Presentation ID: 1254
Title: TI-0032: A Novel Circular RNA-based in vivo CAR-T Therapy
Date/Time: Tuesday, May 12, 2026, 5:00 PM – 6:30 PM ET
Location: Halls B2-C, Exhibit Level

Presentation ID: 2256
Title: A Circular RNA-Encoded CD19×CD3 T-Cell Engager: A Novel Off-the-Shelf Deep B-Cell Depletion Therapy in Autoimmune Diseases
Date/Time: Wednesday, May 13, 2026, 5:00 PM – 6:30 PM ET
Location: Halls B2-C, Exhibit Level

Presentation ID: 3243
Title: A Novel Circular RNA-based HPV16 Therapeutic Vaccine: Eliciting Potent Antitumor Immunity for Tumor Clearance in vivo
Date/Time: Thursday, May 14, 2026, 5:00 PM – 6:30 PM ET
Location: Halls B2-C, Exhibit Level

(Press release, Therorna, MAY 11, 2026, View Source [SID1234665466])

CEL-SCI Enters Strategic Agreement with Amarox for the Registration, Commercialization, and Distribution of Multikine in Saudi Arabia

On May 11, 2026 CEL-SCI Corporation (NYSE American: CVM) reported it has signed a strategic partnership, distribution, and revenue sharing agreement with Amarox for regulatory affairs, marketing and potential commercialization of *Multikine (Leukocyte Interleukin, Injection) in the treatment of head and neck cancer in Saudi Arabia, with an optional extension for the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.

Amarox will support and coordinate the local regulatory process with SFDA, including seeking the SFDA’s Breakthrough Medicine Designation which, upon granting, would make Multikine rapidly available to patients in Saudia Arabia, representing a pivotal shift in CEL-SCI’s commercial trajectory.

The companies will share net revenue from sales of Multikine in Saudi Arabia on a 50%/50% basis.

Upon SFDA approval, Amarox will receive exclusive rights to distribute Multikine for the treatment of head and neck cancer in Saudi Arabia. CEL-SCI retains full ownership of all Multikine intellectual property, manufacturing know-how and global rights.

"Our collaboration with Amarox marks a transformative milestone for CEL-SCI as we advance Multikine toward commercialization in Saudi Arabia and potentially throughout the GCC region," said Geert Kersten, Chief Executive Officer of CEL-SCI. "This agreement establishes an attractive long-term revenue-sharing structure for CEL-SCI and aligns us with one of the region’s most respected pharmaceutical and regulatory organizations."

"Amarox’s excellent track record with the SFDA, combined with its deep commercial infrastructure and oncology expertise, significantly strengthens our ability to bring Multikine to patients in a region prioritizing rapid access to breakthrough cancer therapies. We believe this partnership could position Saudi Arabia as one of the first market globally to commercialize Multikine and represents an important step in CEL-SCI’s broader international commercialization strategy," Kersten concluded.

Dr. Abdullah Alzomaie, Chief Executive Officer of Amarox noted: "Saudi Arabia is rapidly advancing its position as a regional hub for innovative healthcare and advanced therapies. We are pleased to collaborate with CEL-SCI in exploring the regulatory pathway for Multikine and evaluating its potential role in addressing unmet needs in oncology care across Saudi Arabia and the GCC region."

Strong Validation from Leading Regional Oncology Partner

Amarox, one of the fastest growing pharmaceutical companies in Saudi Arabia, is engaged in manufacturing, marketing, and supply of best-in-class therapies. The company is expanding its portfolio of oncology products with a special emphasis on serving the unmet and poorly met needs of countries in the Middle East. As one of the most agile and rapidly expanding pharmaceutical companies in Saudi Arabia, Amarox is focused on regulatory excellence, oncology, specialty pharmaceuticals, and innovative therapies across Saudi Arabia and the GCC region. This strategic partnership reflects Amarox’s interest in exploring the regulatory and commercial potential of innovative oncology therapies in the region.

Amarox has demonstrated strong engagement with the SFDA to address unmet needs, and ranks #1 for applications in the SFDA’s shortage and unregistered medicines initiative for three consecutive years—2022, 2023, and 2024.

Strategic Alignment with Saudi Vision 2030

The SFDA Breakthrough Medicine Program, among other accelerated pathways, aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. By targeting this designation, CEL-SCI and Amarox are aligning Multikine with a high-priority national health initiative, potentially making Saudi Arabia the first region in the world to commercialize this neoadjuvant immunotherapy.

First Berlin, a leading corporate finance and investment boutique based in Berlin, Germany, specializing in independent research, capital market advisory, and investment banking services for small- and mid-cap companies across various sectors, acted as CEL-SCI’s sole advisor in structuring and executing the strategic partnership with Amarox.

About Multikine

Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system.

About Head and Neck Cancer

Head and neck cancer is the 6th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need.

(Press release, Cel-Sci, MAY 11, 2026, View Source [SID1234665465])