On July 30, 2026 Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS04, a CA242-directed ADC, enabling assessment in a Phase 1 trial in patients with gastrointestinal (GI) cancers.

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CA242 is a tumour-specific glycotope which is strongly expressed in a variety of GI cancers including the majority of colorectal (CRC), gastric, pancreatic and biliary tract cancers, and around half of bladder, endometrial and lung cancers, with limited expression in normal tissue.

Previous efforts to target CA242 with ADCs carrying tubulin inhibitor payloads have shown limited clinical efficacy, likely due to inherent resistance of GI cancers to this payload mechanism. In addition, there has been limited success to date with ADCs for the treatment of GI cancers such as those of the colon and stomach with topoisomerase I inhibitors, regardless of the target. There is a need for potent ADCs with differentiated cell-killing mechanisms and directed towards novel targets to enable higher efficacy and to overcome resistance.

IKS04 is a novel CA242-targeting ADC comprising an anti-CA242 humanized antibody and a highly potent pyrrolobenzodiazepine (PBD) prodrug payload. Typically, the use of potent payloads such as PBDs can limit the maximum tolerated dose of ADCs due to systemic adverse events, which in turn limits tumour tissue penetration and efficacy, particularly for high-expression targets such as CA242. This can create an antigen barrier that prevents the drug from penetrating deep into the solid tumour.

Thus, in a first for the ADC field, IKS04 will be co-administered with the unconjugated antibody to tackle the challenge of solid tumour penetration for high potency payloads. This innovative dosing approach is akin to a dosing regimen that is already used in radioimmunotherapy.

Preclinical studies have demonstrated potent activity across a range of GI cancers alongside a favourable therapeutic index – the widest preclinical therapeutic index of any PBD-containing ADC for solid tumours. Anti-cancer activity was further enhanced in high-expressing models by co-administration of IKS04 with the anti-CA242 antibody, validating the IKS04 Regimen.

The concept behind IKS04, including its clinical dosing regimen, is consistent with Iksuda’s general ADC-design approach: selecting the most clinically relevant combination of antibody, conjugation chemistry, linker and payload mechanism to deliver optimal therapeutic index for target and indication. IKS04, like all Iksuda’s ADC programs, incorporates pro-drug technology with tumour-selective activation and release of payload through glucuronide triggers. This design concept, which drives improved tolerability over traditional linkers, has now been clinically validated in Iksuda’s in-clinic ADC programs IKS014, (a HER2-directed ADC containing MMAF), and IKS03, Iksuda’s CD19-directed ADC which also contains the PBD prodrug used in IKS04, and is currently in phase 1 clinical development for B-cell malignancies.

Dr. Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, commented:
"This IND clearance for IKS04 and the IKS04 Regimen, is another important step for Iksuda and further validation of our approach to designing and developing innovative ADCs with the optimal clinical calibration for a given target and indication. IKS04 will be Iksuda’s third ADC to enter clinical development, a significant milestone for the company, with IKS014 and IKS03 both currently progressing through Phase 1 studies. This demonstrates the value of our expanding, innovative platforms, and further de-risks the clinical advancement of our novel antibodies, linkers and payloads. We look forward to progressing IKS04 into Phase 1 studies for GI cancers, an area of high unmet need with limited effective treatment options."

Leon Pappas (Massachusetts General Hospital), Investigator, added:
"IKS04 is directed at a novel target in difficult-to-treat GI cancers. The co-administration regimen and PBD payload are a distinctive approach, and the clinical program will investigate whether they can thereby deliver a better balance of efficacy and tolerability. I am excited to see if this approach helps patients as IKS04 progresses through clinical development."

About IKS04

IKS04 is a first-in-class CA242-targeting ADC comprising an anti-CA242 humanized antibody and a highly potent pyrrolobenzodiazepine (PBD) prodrug payload, incorporating LigaChem Bio’s ADC platform technology and which is associated with tumour-selective activation and release of payload and drives improved tolerability over traditional linker formats. IKS04 is IKSUDA’s third ADC program to enter the clinic.

(Press release, Iksuda Therapeutics, JUL 30, 2026, View Source [SID1234669558])

On July 30, 2026 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the first quarter of fiscal year 2026 (April 1, 2026 to June 30, 2026), marking a period of disciplined execution and operational momentum. Takeda leveraged the resilient performance of its core in-line portfolio to support its long-term strategy, advancing commercial launch preparations and driving critical R&D pipeline milestones. With a clear operational trajectory established in the first quarter and under a new operating model, Takeda remains on track to deliver its strategic and financial commitments for the fiscal year.

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FY2026 First Quarter Highlights

Revenue increased by +10.2% versus the prior-year period on an actual exchange rate (AER) basis and decreased by -0.5% on a Constant Exchange Rate (CER) basis as the negative impact of the loss of exclusivity of VYVANSE was largely offset by growth from core in-line brands.
Core Operating Profit increased by +11.5% on an AER basis and decreased by -0.5% on a CER basis, reflecting continued growth investments supported by the transformation program.
Reported Operating Profit increased by +9.1% on an AER basis.
Core EPS increased by +1.5% at AER and decreased by -11.8% at CER, while Reported EPS decreased by -9.8% YoY.
Adjusted Free Cash Flow amounted to JPY 68.6 billion.
Launch preparations for key late-stage pipeline assets (ORZEYFUL, rusfertide and zasocitinib) are progressing on schedule, with the first approval for ORZEYFUL achieved in China.
FY2026 full-year outlook remains unchanged.
A Capital Markets Day will be held on December 11, 2026, in Tokyo, Japan.
Takeda President and Chief Executive Officer, Julie Kim, commented:
"Our solid performance this quarter marks a good start to the fiscal year and keeps us on track to achieve our full-year targets.

"This quarter’s results reflect our unwavering commitment to financial discipline and the progressing execution of our enterprise transformation. The efficiencies unlocked by this ongoing program are directly fueling our highest priorities in Horizon One in our two-horizon growth strategy: the successful launch of three medicines that have the potential to be blockbuster brands, the advancement of our late-stage pipeline, the enduring resilience of our core in-line portfolio and new capabilities and efficiencies gained through transformation. We look forward to sharing the detailed strategic roadmap for these two growth horizons at our Capital Markets Day in December."

Takeda Chief Financial Officer, Milano Furuta, commented:
"Our first-quarter performance is tracking consistently with management guidance, with the resilience of our core in-line brands largely offsetting our mature portfolio decline, and OPEX savings through the transformation program being strategically reinvested to fund future growth opportunities. Our full-year forecast and guidance remain unchanged."

FINANCIAL HIGHLIGHTS for First Quarter Results ended June 30, 2026

(Billion yen, except percentages and per share amounts)

Item

FY2026 Q1

(Billion JPY)

FY2025 Q1

(Billion JPY)

YoY (AER)

Revenue

1,219.9

1,106.7

+10.2%

Operating Profit

201.4

184.6

+9.1%

Margin

16.5%

16.7%

-0.2pp

Net Profit

113.2

124.2

-8.9%

EPS (Yen)

72

79

-9.8%

Operating Cash Flow

127.6

215.4

-40.8%

Adjusted Free Cash Flow (Non-IFRS)

68.6

190.1

-63.9%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

Item

FY2026 Q1

FY2025 Q1

YoY (AER)

YoY (CER)

Revenue

1,219.9

1,106.7

+10.2%

-0.5%

Operating Profit

358.9

321.8

+11.5%

-0.5%

Margin

29.4%

29.1%

+0.3pp

Net Profit

242.9

237.0

+2.5%

-10.9%

EPS (Yen)

154

151

+1.5%

-11.8%

FY2026 Full-year Forecast and Guidance

There are no changes to the FY2026 forecast and management guidance announced on May 13, 2026.

(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% to 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 Progress Building the Foundation for Future Growth
Takeda’s next-generation growth engine is anchored by three, high-potential, late-stage pipeline assets expected to obtain regulatory approvals in the U.S. and other key regions in the coming year. While this represents a pivotal period of strategic investment and commercial launch execution, Takeda is positioned to deliver tangible milestones over the next 12 to 24 months. By establishing a track record of launch excellence today, Takeda is securing the foundation that will underpin the Company’s sustained, long-term growth and meaningful impact for patients globally.

ORZEYFUL

An orexin receptor agonist with a first-in-class mechanism of action, designed to address the orexin deficiency that causes narcolepsy type 1 (NT1).
The first approval of oveporexton was recently granted in China under the brand name ORZEYFUL.
New drug applications are currently under review in the United States and Japan.
Preparations for the expected launches in the U.S., Japan and China in the second half of the year are well underway.
At SLEEP 2026, Takeda presented Phase 3 clinical trial results for ORZEYFUL demonstrating improvements in daily functioning, cognition and nighttime sleep in patients with narcolepsy type 1.
Rusfertide

A potential first-in-class hepcidin mimetic for the treatment of adults with the blood cancer polycythemia vera (PV).
Demonstrated significant improvements in hematocrit control and phlebotomy reduction for patients with PV in a Phase 3 clinical trial.
Granted Priority Review by the U.S. FDA, Takeda is prepared for a commercial U.S. launch expected in the second half of 2026.
Zasocitinib

A next generation, highly selective and potent TYK2 inhibitor that has demonstrated rapid, durable skin clearance in a convenient once-daily oral pill with no fasting restrictions.
Achieved positive topline results across the primary endpoint and all key secondary endpoints in a head-to-head Phase 3 clinical trial against deucravacitinib.
Achieved consistent, high rates of skin clearance across the body, including hard-to-treat and high-impact sites in Phase 3 psoriasis studies.
Takeda is making the necessary investments with a view toward regulatory submissions in 2026 and a commercial launch anticipated in the first half of 2027.
Capital Allocation and Shareholder Returns
Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation with the goal of driving growth and enabling the company to deliver returns to shareholders under its progressive dividend policy. The annual dividend forecast for FY2026 is JPY 204 per share.

Additional Information Regarding FY2026 First Quarter Results
Takeda will host a conference call for investors and analysts on Thursday, July 30, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first quarter results.

A live webcast of the conference call and the presentation materials will be available in the Investor Relations section of Takeda’s website (www.takeda.com/investors). The presentation materials include details on Takeda’s FY2026 first quarter results, business progress and pipeline updates, as well as definitions of non-IFRS measures.

(Press release, Takeda, JUL 30, 2026, View Source [SID1234669557])

On July 30, 2026 Sumitomo Pharma America, Inc. (SMPA) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to enzomenib (DSP-5336) for the treatment of patients with acute lymphoblastic leukemia (ALL). Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth.

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Orphan drug designation is granted by the FDA to a drug or biological product to prevent, diagnose, or treat a rare disease or condition.1 The FDA previously granted orphan drug designation to enzomenib for acute myeloid leukemia (AML) in June 2022. The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose-escalation/dose-expansion study in patients with relapsed or refractory acute leukemia (NCT04988555) and the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study.

"The availability and selection of treatment choices is a major clinical and logistical challenge for patients with acute lymphoblastic leukemia, a challenge underscored by the complexity of sequencing therapies," said Tsutomu Nakagawa, President and CEO of Sumitomo Pharma America (SMPA). "Receiving Orphan Drug Designation for enzomenib for the treatment of ALL is an exciting development that reinforces the molecule’s potential. We will work closely with the FDA to advance clinical research of enzomenib in the hopes of bringing an innovative new treatment option to people living with ALL."

ALL, also known as acute lymphocytic leukemia, progresses quickly if untreated. It is characterized by an acute onset and occurs when the bone marrow produces an overabundance of lymphocytes. In ALL, impaired blood cell production can increase susceptibility to infections and may result in anemia and an increased risk of bleeding. ALL cells may spread to other bodily areas including the brain and spinal cord.2

About Enzomenib (DSP-5336)

Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth. Menin is a scaffold nuclear protein that plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.3,4 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.3,5 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1 and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutation.6,7 The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose-escalation/dose-expansion study in patients with relapsed or refractory acute leukemia (NCT04988555) and the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study. The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in June 2024. Japan’s Ministry of Health, Labour and Welfare (MHLW) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in September 2024.

(Press release, Sumitomo Dainippon Pharma, JUL 30, 2026, View Source [SID1234669556])

On July 30, 2026 CEL-SCI Corporation (NYSE American: CVM) reported that a manuscript highlighting the latest findings from its Phase 3 study titled "A Novel Neoadjuvant Immunotherapy Confers Improved Overall Survival in Oral Cancer Patients with Low Tumor PD-L1 Expression: The IT-MATTERS Clinical Trial – Prognostic Role of Tumor PD-L1 Expression," has been accepted for publication in Oral Oncology, one of the world’s leading peer-reviewed journals dedicated to head and neck cancer research and treatment.

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The manuscript, authored by Eyal Talor, Ph.D. (CEL-SCI Chief Scientific Officer, the developer of Multikine) and colleagues, is based on data from CEL-SCI’s landmark Phase 3 IT-MATTERS clinical trial evaluating Multikine (Leukocyte Interleukin, Injection)* in the treatment of newly diagnosed treatment naïve, resectable, locally advanced head and neck cancer patients. In accordance with the journal’s publication policies, CEL-SCI will disclose the scientific findings following publication in Oral Oncology.

"The acceptance of this manuscript by Oral Oncology represents another important validation of the quality and significance of our clinical data," said Geert Kersten, CEO of CEL-SCI. "Publication in leading peer-reviewed journals expands awareness of Multikine among oncologists, head and neck surgeons and cancer researchers around the world. As we prepare to begin patient enrollment in our Confirmatory Registration Study, we believe growing recognition within the scientific community will further strengthen the foundation supporting Multikine’s potential to become an important new treatment option for patients with low PD-L1 head and neck cancer."

In CEL-SCI’s Phase 3 study, a well-defined population of newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low tumor PD-L1 expression and no lymph node involvement treated with Multkine before receiving standard of care had a 73% five-year overall survival rate compared to 45% in patients receiving standard of care alone.

Unlike currently available immune checkpoint inhibitor therapies that primarily target patients with higher PD-L1 expression, Multikine is being developed specifically for patients with low PD-L1 tumor expression—an underserved patient population with limited treatment options and a recognized unmet medical need.

CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which is designed to confirm the previously observed overall survival benefit in this predefined target patient population. The registration study aims to enroll patients globally at clinical centers across the United States, Europe and Asia and is designed based on the approximately 97% statistical power to detect the previously observed overall survival hazard ratio of 0.34 in the same selected population of the completed Phase 3 study.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced 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. In the world’s largest head and neck cancer Phase 3 study in the same selected population, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

(Press release, Cel-Sci, JUL 30, 2026, View Source [SID1234669555])

On July 30, 2026 One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, reported data establishing that single-cell RNA expression profiles can be generated from the standard, formalin-fixed paraffin-embedded (FFPE) pathology specimens obtained in routine cancer care using the company’s proprietary platform, OneMap.

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The study, conducted with collaborators at Centre Léon Bérard, Hôpital Bichat–Claude Bernard, Institut Curie, and Memorial Sloan Kettering Cancer Center, was released as a preprint on BiorXiv.

"Every tumor is a unique ecosystem of many different types of cells, some cancerous, some not. Single cell profiling enables us to understand what those cells are, what they’re doing and potentially how that may impact treatment outcomes," said Helena Yu, MD, thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. "Until now that type of analysis required different types of samples and workflows than we deploy in clinical care. This study shows we can do that analysis from the same samples we already collect, paving the way to more deeply explore how we can leverage this technology to guide treatment."

The study included multiple institutions from multiple regions and varied sample and tumor types to reflect the diversity encountered in real world clinical care. The data include findings from 88 single-nucleus experiments spanning bladder, breast, colon, lung, ovarian, and pancreatic cancers, including 36 core biopsies. The assay produced reproducible measurements of cellular composition and cell-type-resolved gene expression. Technical reproducibility was high (median correlation > 0.92 in cell-type proportions across replicates), and automated estimates of immune infiltration closely matched pathologists’ assessments of tumor-infiltrating lymphocytes. The workflow succeeded on archival blocks up to roughly a decade old and on ultra-low-input biopsies, and it quantified clinically relevant antibody-drug-conjugate targets.

The assay uses single-nucleus RNA sequencing to measure gene activity inside individual cells present in thin slices of tissue prepared for standard pathologic analyses. OneMap, an A.I.-powered software engine, identifies which cells are present and measures what each type is doing. OneMap then produces a single standardized report for each sample, eliminating the batch processing that older single-cell methods required.

"Single-cell analysis is a valuable addition to current molecular profiling, revealing important information about a tumor that standard tests cannot. Previously, it required the wrong kind of samples, too much tissue and analysis that only worked in large batches, making it impractical for real-world patient care," said Vincent Miller, executive chairman of One Biosciences. "This study validates our approach, which runs on ordinary pathology slides every hospital already produces, needs only a fraction of the tissue, and returns a standardized report for one patient at a time, creating a true sample-to-report solution that can enable more targeted clinical trials and ultimately improve patient care."

Standard tumor diagnostics average signal across millions of cells, potentially obscuring subpopulations of cells that might drive resistance, including immune cells. Single-cell profiling analyzes tumors one cell at a time, providing critical insights for both researchers and clinicians. Ongoing studies will explore whether single cell profiles can better select patients. In the clinic, single cell profiles offer an important addition to standard bulk profiling that grounds treatment decisions in the composition of a patient’s own tumor.

(Press release, One Biosciences, JUL 30, 2026, View Source [SID1234669554])