Sumitomo Pharma America Announces Enzomenib (DSP-5336) Receives FDA Orphan Drug Designation for Treatment of Acute Lymphoblastic Leukemia

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])

Takeda Quarterly Financial Report For the Quarter Ended June 30, 2026

On July 30, 2026 Takeda reported quarterly financial report for the quarter ended June 30, 2026.

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(Presentation, Takeda, JUL 30, 2026, View Source [SID1234669913])

Keros Therapeutics to Receive Development Milestone Payment from Partner Takeda

On July 30, 2026 Keros Therapeutics, Inc. ("Keros") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported that it will receive a $20 million development milestone payment under the terms of the license agreement of elritercept with partner Takeda, following the dosing of the first patient in the ELRiSE MDS clinical trial. ELRiSE MDS is a Phase 3, multicenter, open-label, randomized trial to compare the efficacy and safety of elritercept versus epoetin alfa for the treatment of anemia due to very low, low, or intermediate risk myelodysplastic syndromes ("MDS").

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"We are delighted by the continued progress of the elritercept program," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer of Keros. "We are encouraged by the positive signals that were observed in the Phase 2 clinical trial of elritercept in patients with very low-, low-, or intermediate-risk MDS, which were observed in patients with MDS both with and without ring sideroblasts."

Under the terms of the global license agreement with Takeda to further develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau, which became effective on January 16, 2025, Keros received a $200 million upfront cash payment in February 2025, and is eligible to receive development, commercial and sales milestones with the potential to exceed $1.1 billion. Keros will also be eligible to receive tiered royalties on net sales.

Keros expects to distribute 25% of the net cash proceeds from this milestone payment to its stockholders following receipt of the payment.

About Elritercept

Elritercept is an engineered ligand trap comprised of a modified ligand-binding domain of the TGF-ß receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain. Elritercept is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with MDS and in patients with myelofibrosis.

(Press release, Keros Therapeutics, JUL 30, 2026, View Source [SID1234669537])

Takeda Announces FY2026 First Quarter Results, Near-Term Launch Preparations and Pipeline Progress on Track

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])

Labcorp Announces 2026 Second Quarter Results; Raises Full Year 2026 Guidance

On July 30, 2026 Labcorp Holdings Inc. (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported results for the second quarter ended June 30, 2026 and updated its full-year financial guidance.

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"Labcorp delivered another very strong quarter, with 6% revenue growth, significant margin expansion, and double-digit adjusted EPS growth reflecting continued momentum across the business," said Adam Schechter, Chairman and CEO of Labcorp. "During the second quarter, we expanded our leadership in oncology and other high-growth specialty areas, strengthened our position as the partner of choice for health systems, biopharmaceutical companies, and regional/local laboratories, and advanced our use of technology to improve the experience for consumers and providers. Our performance and continued execution position us well to deliver sustainable growth and long-term value for customers and shareholders."

Labcorp continues to advance its strategic priorities:

Lead in specialty testing, with several advancements in Labcorp Oncology:

•Added an advanced DPYD genotyping test that helps identify patients at risk for severe chemotherapy treatment-related toxicity.
•Launched ColoSense nationwide, the first FDA-approved, RNA-based colorectal cancer screening test with at-home collection. With Medicare and expanding commercial payer coverage, this test increases patient access to screening and enables earlier detection. As ColoSense’s primary nationwide distributor, we are further strengthening our comprehensive colorectal cancer portfolio.
•Entered into a clinical trial collaboration with Fox Chase Cancer Center to evaluate Labcorp’s Plasma Detect Genome MRD in patients at risk of early-stage non-small cell lung cancer recurrence.
•Expanded nationwide access to Roche’s FDA-approved VENTANA PTEN (SP218) companion diagnostic for people living with prostate cancer who may now be eligible for combination treatment with AstraZeneca’s targeted therapy TRUQAP.

Be a partner of choice for health systems and regional/local laboratories:

•Awarded once again a Department of Defense contract to provide laboratory testing for service members and their families across military hospitals worldwide.
•Completed the acquisition of select outreach laboratory services from Parkview Health in Indiana and Ohio.
•Completed the acquisition of Tribal Diagnostics, a clinical laboratory serving communities in Oklahoma and Texas.

Grow Consumer Health:

•Announced the Marker by Labcorp Genetic Health Panel through Labcorp OnDemand where consumers can get their biomarker and genetic testing and insights from a single source.
•Introduced Canada’s first at-home, self-collection test to measure women’s fertility-related hormones and men’s testosterone levels.
•Launched an AI-powered app, MyLabcorp, which has been downloaded by millions of consumers. The app allows patients to schedule appointments, view their test results, and gain deeper insights into their health.

Shape our future through technology and innovation:

•Expanded a collaboration with Epic to place 6,500-plus diagnostic tests on Epic’s Aura platform.
•Enhanced the patient experience at Labcorp’s Patient Service Centers, through expanded appointment availability, streamlined scheduling, and proactive rescheduling reminders and assistance.

Labcorp also remains committed to a disciplined allocation of capital. In the second quarter of 2026, the company invested $225.7 million in acquisitions, repurchased $353.8 million of stock, and paid out $58.7 million in dividends. The company also paid down $500.0 million in senior notes in June. On July 9, 2026, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on September 11, 2026, to stockholders of record at the close of business on August 28, 2026. In July, the Board of Directors approved an increase of $1.0 billion in the company’s share repurchase authorization, bringing the remaining total authorization to $1.4 billion.
3

LABCORP HOLDINGS INC. AND SUBSIDIARIES
CONSOLIDATED RESULTS
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 Delta 2026 2025 Delta
Revenue Summary (Dollars in millions)
Total Revenue $ 3,731.1 $ 3,527.3 5.8 % $ 7,268.7 $ 6,872.4 5.8 %
Organic(1)
4.2 % 3.6 %
Acquisitions, net of Divestitures(2)
1.2 % 1.3 %
Foreign Exchange 0.4 % 0.9 %
(1) Excludes the impact from acquisitions, divestitures, and currency, as well as other strategic actions taken in Early Development.
(2) Includes the impact from strategic actions taken in Early Development.
Earnings Summary (Dollars in millions, except per share data)
Operating Income ("OI") $ 451.6 $ 394.5 $ 832.4 $ 720.5
OI as % of Revenue 12.1 % 11.2 % 90 bps 11.5 % 10.5 % 100 bps
Adjustments (3)
$ 137.1 $ 137.1 $ 264.2 $ 280.1
Adjusted Operating Income ("AOI") (4)
$ 588.7 (5) $ 531.6 $ 1,096.6 $ 1,000.6
AOI as % of Revenue 15.8 % (5) 15.1 % 70 bps 15.1 % 14.6 % 50 bps
Net Earnings Attributable to Labcorp Holdings Inc. $ 298.7 $ 237.9 $ 576.5 $ 450.7
Diluted EPS $ 3.64 $ 2.84 $ 6.99 $ 5.36
Adjusted EPS (4)
$ 4.99 $ 4.35 14.9 % $ 9.24 $ 8.19 12.8 %
(3) Adjustments include amortization, impairment charges, restructuring charges, and special items.
(4) Non-GAAP financial measure. See "Reconciliation of Non-GAAP Measures" for additional information.
(5) The increase in adjusted operating income and margin was due to organic growth and operating efficiencies.

4

LABCORP HOLDINGS INC. AND SUBSIDIARIES
CONSOLIDATED RESULTS
Three Months Ended June 30, Six Months Ended June 30,
2026 2025 2026 2025
Cash Flow Summary (Dollars in millions)
Operating Cash Flow $ 445.5 $ 620.6 $ 637.0 $ 639.1
Capital Expenditures 131.6 77.9 252.6 203.9
Free Cash Flow $ 313.9 (1) $ 542.7 $ 384.4 $ 435.2
(1) The difference in free cash flow was primarily due to working capital timing and planned increases in capital expenditures.

Capital Allocation Summary

•At the end of the quarter, Labcorp’s cash and cash equivalents balance was $141.8 million and total debt was $5.86 billion. In June, we retired $500.0 million in senior notes.
•During the quarter, the company invested $225.7 million in acquisitions, repurchased $353.8 million of stock, and paid out $58.7 million in dividends.
5

LABCORP HOLDINGS INC. AND SUBSIDIARIES
Diagnostics Laboratories Segment Summary

Three Months Ended June 30,
2026 2025 Delta
Revenue Summary (Dollars in millions)
Total Revenue $ 2,900.7 $ 2,748.8 5.5 %
Organic 3.6 %
Acquisitions, net of Divestitures 1.9 %
Earnings Summary (1) (Dollars in millions)
Adjusted Operating Income ("AOI") (2)
$ 522.6 (3) $ 482.8
AOI as % of Revenue 18.0 % (3) 17.6 % 50 bps
(1) Non-GAAP financial measure. See "Reconciliation of Non-GAAP Measures" for additional information.
(2) Excludes amortization, restructuring charges, special items, and unallocated corporate expenses.
(3) Adjusted Operating Income and margin increased due to organic growth and operating efficiencies.

Three Months Ended June 30, 2026
Requisition Price/Mix
Volume Delta (4)
Delta (4)
Metrics Summary
Total 3.0 % 2.5 %
Organic (5)
1.8 % 1.8 %
Acquisitions, net of Divestitures 1.3 % 0.6 %
Foreign Exchange — % — %
(4) Column shows changes versus the three months ended June 30, 2025.
(5) Organic price/mix includes lab management agreements.

6

LABCORP HOLDINGS INC. AND SUBSIDIARIES
Biopharma Laboratory Services Segment Summary
Three Months Ended June 30,
2026 2025 Delta
Revenue Summary (Dollars in millions)
Total Revenue $ 836.2 $ 784.8 6.5 %
(1)
Organic(2)
6.2 %
Acquisitions, net of Divestitures(3)
(1.4) %
Foreign Exchange 1.8 %
(1) Central Labs revenue growth of 9.8%; Early Development revenue was down 1.4%.
(2) Excludes the impact from acquisitions, divestitures, and currency, as well as other strategic actions taken in Early Development.
(3) Includes the impact from strategic actions taken in Early Development.
Earnings Summary (4) (Dollars in millions)
Adjusted Operating Income ("AOI") (5)
$ 142.2
(6)
$ 123.3
AOI as % of Revenue 17.0 %
(6)
15.7 % 130 bps
(4) Non-GAAP financial measure. See "Reconciliation of Non-GAAP Measures" for additional information.
(5) Excludes amortization, restructuring charges, special items, and unallocated corporate expenses.
(6) Adjusted Operating Income and margin increased, driven by organic growth and operating efficiencies from the strategic actions taken in Early Development.

As of
June 30, 2026
Metrics Summary (Dollars in billions)
TTM Net Orders $ 3.32
TTM Book to Bill 1.03
Backlog $ 8.73
(7)
Next Twelve Months Forecast Backlog Conversion $ 2.75

(Press release, LabCorp, JUL 30, 2026, View Source [SID1234669538])