On October 21, 2026 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2026.

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Third-quarter sales increased 14.5 percent on a reported basis and 7.0 percent on a comparable basis.
Third-quarter GAAP diluted EPS of $0.53 and adjusted diluted EPS of $1.42, which excludes specified items.
Abbott projects full-year 2026 comparable sales growth to be approximately 6.0 percent1.
Abbott reaffirms the midpoint of previously provided full-year 2026 adjusted diluted EPS guidance range and tightens the range to $5.50 to $5.55.
In August, Abbott announced U.S. Food and Drug Administration (FDA) approval for Libre Duo, the world’s first dual glucose-ketone biowearable sensor. By providing real-time visibility into glucose and ketone levels, this new technology helps optimize the management of diabetes by detecting rising ketone levels, which can lead to diabetic ketoacidosis, a serious health condition for people with diabetes.
In August, Abbott announced that the company received CE Mark for its Amulet 360 Left Atrial Appendage (LAA) Occluder, a next-generation device designed to reduce the risk of stroke in patients with atrial fibrillation (AFib).
In August, Abbott announced the launch of Similac 360 Total Care Made With Whole Milk — the first and only commercially sterile, ready-to-feed liquid infant formula made with whole milk in the United States.
In September, Abbott announced FDA approval for its TactiFlex Duo Ablation Catheter, Sensor Enabled, designed to deliver both pulsed field ablation (PFA) and radiofrequency (RF) energy to treat patients battling atrial fibrillation.
In September, Abbott launched SimpleScreen CRC, an FDA-approved, blood-based colorectal cancer screening test for adults age 45 and older who are at average risk for the disease.
"Abbott delivered strong third-quarter results, reflecting balanced growth across our portfolio," said Robert B. Ford, chairman and chief executive officer, Abbott. "With strong performance across multiple businesses and a robust pipeline of innovation, we are well-positioned to deliver sustainable growth in the years ahead."

THIRD-QUARTER BUSINESS OVERVIEW

Comparable sales growth:
Management believes that measuring sales growth on a comparable basis is an appropriate way for investors to best understand the underlying performance of the business. Comparable sales growth includes the prior and current year sales of Exact Sciences, a cancer diagnostics company that Abbott acquired on March 23, 2026. Comparable sales growth excludes the impact of foreign exchange and revenue in both the prior and current year related to compensation payments that Abbott’s Structural Heart business received as part of a multi-year agreement with a competitor. The final payment under this agreement was recognized in the first quarter of 2026.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third Quarter 2026 Results (3Q26)

Sales 3Q26 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

5,504

958

1,853

—

2,687

International

7,509

1,304

1,452

1,614

3,139

Total reported

13,013

2,262

3,305

1,614

5,826

% Change vs. 3Q25

U.S.

28.0

7.9

109.2

n/a

6.6

International

6.2

3.1

6.2

6.8

7.2

Total reported

14.5

5.1

46.7

6.8

6.9

Total reported excl. foreign exchange impact

14.8

4.9

46.6

8.4

7.4

Comparable sales growth

7.0

4.9

6.4

8.4

7.8

U.S.

7.9

7.9

8.4

n/a

7.6

International

6.4

2.8

4.0

8.4

8.0

First Nine Months 2026 Results (9M26)

Sales 9M26 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

14,994

2,673

4,418

—

7,890

International

21,776

3,750

4,159

4,539

9,328

Total reported

36,770

6,423

8,577

4,539

17,218

% Change vs. 9M25

U.S.

17.7

(4.5)

72.0

n/a

7.1

International

8.2

1.1

6.3

9.3

11.7

Total reported

11.9

(1.3)

32.4

9.3

9.6

Total reported excl. foreign exchange impact

10.5

(2.1)

30.8

8.7

7.8

Comparable sales growth

5.2

(2.1)

3.8

8.7

8.2

U.S.

4.7

(4.5)

4.9

n/a

8.1

International

5.7

(0.3)

2.4

8.7

8.3

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of comparable sales growth.

Nutrition

Third Quarter 2026 Results (3Q26)

Sales 3Q26 ($ in millions)

Total

Pediatric

Adult

U.S.

958

577

381

International

1,304

486

818

Total reported

2,262

1,063

1,199

% Change vs. 3Q25

U.S.

7.9

11.0

3.5

International

3.1

6.4

1.3

Total reported

5.1

8.8

2.0

Total reported excl. foreign exchange impact

4.9

8.7

1.8

Comparable sales growth

4.9

8.7

1.8

U.S.

7.9

11.0

3.5

International

2.8

6.0

1.0

Worldwide Nutrition sales increased 5.1 percent on a reported basis and 4.9 percent on a comparable basis in the third quarter.

Worldwide Nutrition results were driven by broad-based growth across the portfolio, including sales growth of nearly 9.0 percent in Worldwide Pediatric.

On a sequential basis, Worldwide Nutrition sales increased $118 million compared to the second quarter of 2026.

First Nine Months 2026 Results (9M26)

Sales 9M26 ($ in millions)

Total

Pediatric

Adult

U.S.

2,673

1,613

1,060

International

3,750

1,428

2,322

Total reported

6,423

3,041

3,382

% Change vs. 9M25

U.S.

(4.5)

(4.8)

(4.0)

International

1.1

3.7

(0.5)

Total reported

(1.3)

(1.0)

(1.6)

Total reported excl. foreign exchange impact

(2.1)

(1.6)

(2.6)

Comparable sales growth

(2.1)

(1.6)

(2.6)

U.S.

(4.5)

(4.8)

(4.0)

International

(0.3)

2.4

(2.0)

Diagnostics*

Third Quarter 2026 Results (3Q26)

Sales 3Q26 ($ in millions)

Total

Core Laboratory

Cancer Diagnostics

Rapid/Molecular
Diagnostics

U.S.

1,853

389

938

526

International

1,452

1,049

30

373

Total reported

3,305

1,438

968

899

% Change vs. 3Q25

U.S.

109.2

6.3

n/a

1.1

International

6.2

5.1

n/a

1.0

Total reported

46.7

5.4

n/a

1.1

Total reported excl. foreign exchange impact

46.6

5.4

n/a

0.9

Comparable sales growth

6.4

5.4

13.8

0.9

U.S.

8.4

6.3

13.9

1.1

International

4.0

5.1

12.1

0.7

Worldwide Diagnostics sales increased 46.7 percent on a reported basis and 6.4 percent on a comparable basis in the third quarter.

Worldwide Core Laboratory Diagnostics results were driven by balanced growth across major geographic regions including the U.S., Europe, Japan, and Latin America.

Cancer Diagnostics results were driven by growth of Cologuard and also reflect contributions to growth from the precision oncology and international businesses.

First Nine Months 2026 Results (9M26)

Sales 9M26 ($ in millions)

Total

Core Laboratory

Cancer Diagnostics

Rapid/Molecular
Diagnostics

U.S.

4,418

1,113

1,921

1,384

International

4,159

3,015

62

1,082

Total reported

8,577

4,128

1,983

2,466

% Change vs. 9M25

U.S.

72.0

6.1

n/a

(8.9)

International

6.3

5.8

n/a

1.9

Total reported

32.4

5.9

n/a

(4.5)

Total reported excl. foreign exchange impact

30.8

4.0

n/a

(5.4)

Comparable sales growth

3.8

4.0

13.5

(5.4)

U.S.

4.9

6.1

13.5

(8.9)

International

2.4

3.2

15.0

(0.4)

*Beginning in 2026, Abbott aggregated its previously reported Rapid Diagnostics, Molecular Diagnostics, and Point of Care businesses into the Rapid and Molecular Diagnostics business. On March 23, 2026, Abbott completed the acquisition of Exact Sciences. Following the acquisition, the sales of Exact Sciences are presented as Abbott’s Cancer Diagnostics business.

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of comparable sales growth.

Established Pharmaceuticals

Third Quarter 2026 Results (3Q26)

Sales 3Q26 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,614

1,195

419

Total reported

1,614

1,195

419

% Change vs. 3Q25

U.S.

n/a

n/a

n/a

International

6.8

9.0

1.1

Total reported

6.8

9.0

1.1

Total reported excl. foreign exchange impact

8.4

10.9

1.6

Comparable sales growth

8.4

10.9

1.6

U.S.

n/a

n/a

n/a

International

8.4

10.9

1.6

Established Pharmaceuticals sales increased 6.8 percent on a reported basis and 8.4 percent on a comparable basis in the third quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 9.0 percent on a reported basis and 10.9 percent on a comparable basis, led by double-digit growth in India and several markets across the Latin America and Asia Pacific regions.

First Nine Months 2026 Results (9M26)

Sales 9M26 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

4,539

3,448

1,091

Total reported

4,539

3,448

1,091

% Change vs. 9M25

U.S.

n/a

n/a

n/a

International

9.3

10.5

5.6

Total reported

9.3

10.5

5.6

Total reported excl. foreign exchange impact

8.7

10.4

3.6

Comparable sales growth

8.7

10.4

3.6

U.S.

n/a

n/a

n/a

International

8.7

10.4

3.6

Medical Devices

Third Quarter 2026 Results (3Q26)

Sales 3Q26 ($ in millions)

Total

Rhythm
Management

Electro-
physiology*

Heart
Failure

Vascular

Structural
Heart*

Neuro-
modulation

Diabetes
Care

U.S.

2,687

380

429

303

290

228

185

872

International

3,139

372

444

84

496

364

66

1,313

Total reported

5,826

752

873

387

786

592

251

2,185

% Change vs. 3Q25

U.S.

6.6

9.0

18.1

8.4

3.4

(11.1)

(5.6)

9.4

International

7.2

10.4

12.2

(2.7)

6.7

12.2

13.6

4.2

Total reported

6.9

9.7

15.0

5.8

5.4

1.9

(1.2)

6.2

Total reported excl. foreign exchange impact

7.4

10.0

15.5

6.0

5.7

2.6

(1.1)

6.7

Comparable sales growth

7.8

10.0

15.5

6.0

5.7

6.9

(1.1)

6.7

U.S.

7.6

9.0

18.1

8.4

3.4

(2.3)

(5.6)

9.4

International

8.0

11.0

13.1

(1.6)

7.1

13.5

13.9

4.9

Worldwide Medical Devices sales increased 6.9 percent on a reported basis and 7.8 percent on a comparable basis in the third quarter.

Sales growth in the quarter was led by double-digit growth in Electrophysiology and Rhythm Management.

In Diabetes Care, sales of continuous glucose monitors grew 7.3 percent on a reported basis and 7.7 percent on a comparable basis.

First Nine Months 2026 Results (9M26)

Sales 9M26 ($ in millions)

Total

Rhythm
Management

Electro-
physiology*

Heart
Failure

Vascular

Structural
Heart*

Neuro-
modulation

Diabetes
Care

U.S.

7,890

1,096

1,227

908

875

677

551

2,556

International

9,328

1,083

1,295

269

1,491

1,090

203

3,897

Total reported

17,218

2,179

2,522

1,177

2,366

1,767

754

6,453

% Change vs. 9M25

U.S.

7.1

10.4

16.0

10.2

5.2

(10.2)

(2.4)

9.3

International

11.7

13.9

14.5

7.9

8.0

16.1

18.1

10.5

Total reported

9.6

12.1

15.2

9.7

7.0

4.4

2.4

10.0

Total reported excl. foreign exchange impact

7.8

10.6

13.8

8.9

5.2

2.6

1.3

7.7

Comparable sales growth

8.2

10.6

13.8

8.9

5.2

6.5

1.3

7.7

U.S.

8.1

10.4

16.0

10.2

5.2

(2.3)

(2.4)

9.3

International

8.3

10.8

11.9

4.6

5.2

12.8

13.5

6.6

*Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder device and related accessories were transferred from Structural Heart to Electrophysiology on January 1, 2026. As a result, $55 million of sales in the third quarter of 2025 and $156 million of sales in the first nine months of 2025 were moved from Structural Heart to Electrophysiology.

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of comparable sales growth.

Abbott’s Financial Guidance
Abbott projects full-year 2026 comparable sales growth to be approximately 6.0%1.

Abbott projects full-year 2026 adjusted diluted earnings per share of $5.50 to $5.55.

Abbott projects fourth-quarter 2026 adjusted diluted earnings per share of $1.62 to $1.67.

Abbott has not provided the related GAAP financial measures on a forward-looking basis for these forward-looking non-GAAP financial measures because the company is unable to predict with reasonable certainty and without unreasonable effort the timing and impact of certain items such as restructuring and cost reduction initiatives, charges for intangible asset impairments, acquisition-related expenses, and foreign exchange, which could significantly impact Abbott’s results in accordance with GAAP.

(Press release, Abbott, OCT 21, 2026, View Source [SID1234673635])

On October 21, 2026 Telix reported a financial update on its commercial and operational performance for the quarter ended September 30, 2026 (Q3 2026).

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Q3 2026 Highlights
Group revenue of US$245 million increased 19% over the prior corresponding quarter (Q3 2025) driven by continued strong demand for the commercial portfolio, in line with expectations. September sales drove a higher quarterly exit rate indicating continued strength in underlying demand for Telix’s PSMA products.

Precision Medicine revenue of US$201 million, increased 30% over the prior corresponding quarter, driven by both Gozellix and Illuccix2. Telix’s commercial PSMA-PET imaging3 portfolio continued to strengthen its market position, driven by strong demand for our clinically differentiated products.

U.S. Food and Drug Administration (FDA) approved Pixclara4 for glioma imaging, marking a significant milestone and establishing the first approved imaging agent for this indication in the U.S.5. The first commercial doses were administered in September 20266.

BiPASS, a Phase 3 study evaluating pre-biopsy prostate cancer detection, completed enrollment7, with the FDA supporting an NDA pathway and granting Fast Track Designation.

Telix announced a merger with Isotope Technologies Munich SE (ITM). The merger creates a leading radiopharmaceutical platform with one of the industry’s broadest therapeutics pipelines, supported by best-in-class isotope production, manufacturing, and supply chain capabilities.

Telix reaffirmed that FY 2026 revenue and other income is expected to be in excess of US$1 billion, with revenue tracking in line with upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million of other income. The Company has also revised its FY 2026 R&D expenditure guidance range to US$240 million to US$260 million.
Q3 2026 Revenue
Revenue (US$M) Q3 2026 Q3 2025 % Change Q2 2026 % Change
Group revenue 245 206 19% 247 (1)%
Precision Medicine revenue10 201 155 30% 202 —%
TMS revenue11 44 47 (6)% 45 (2)%
Executive Commentary
Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, "Demand for both Gozellix and Illuccix remained strong during the quarter, with U.S. dose volumes increasing 1% quarter-over-quarter, in line with our expectations and reflecting expected summer seasonality. We are pleased by the strong September exit run rate, supporting our confidence in delivering over 25% Precision Medicine revenue growth in 2026. We achieved an important milestone with the FDA approval of Pixclara, expanding our commercial portfolio, establishing a presence in neuro-oncology and further diversifying our revenue base. During the quarter, we announced a transformative merger with ITM, creating a leading vertically integrated radiopharmaceutical company with one of the industry’s broadest therapeutic pipelines and expanded isotope production and global manufacturing capabilities. This is aligned with our long-term growth strategy reinforcing our ability to reliably serve patients at scale."

Therapeutics Business Unit
TLX591-Tx (177Lu rosopatamab tetraxetan): Following FDA review and alignment of the Part 1 safety data, Telix is finalizing its IND amendment to the FDA to support progression to Part 2 of the ProstACT Global Phase 3 study in the U.S.12. Outside the U.S., Part 2 of the global study continues to enroll patients across seven countries: Australia, New Zealand, Canada, Türkiye, the UK, Singapore, and South Korea. Regulatory approvals have also been obtained to proceed in China and Japan13.

TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA): OPTIMAL-PSMA14, a Phase 2 study evaluating TLX597-Tx in metastatic androgen pathway modulator-resistant (mAPMR) prostate cancer15, completed enrollment of 120 patients16. A data readout is expected in the first half of 2027. OPTIMAL-e17, a Phase 2 study evaluating TLX597-Tx in metastatic androgen pathway modulator-naive or -sensitive (mAPMN/S) prostate cancer18, continues to demonstrate strong enrollment momentum.

TLX250-Tx (177Lu girentuximab tetraxetan): Continued enrollment of patients in LUTEON19, a pivotal trial of TLX250-Tx in advanced clear cell Renal Cell Carcinoma (ccRCC). The trial is evaluating the safety and efficacy of TLX250-Tx compared with the investigator’s choice of monotherapy consistent with standard of care.

TLX101-Tx (iodofalan 131I): Following full enrollment of the first cohort in Part 1 of the Phase 3 IPAX BrIGHT study20, an IND amendment was filed with the FDA to support expansion of the trial into Part 1b in the U.S. IPAX-221, a Phase 1 study of TLX101-Tx in patients with newly diagnosed glioblastoma met its primary endpoint, establishing a maximum tolerated dose (MTD) of two 5 GBq cycles in combination with standard of care. No dose-limiting toxicities were observed, supporting advancement of IPAX-2 to Phase 222.

Precision Medicine Business Unit

68Ga-PSMA-11 for prostate cancer imaging:

BiPASS, a Phase 3 study of 68Ga-PSMA-11 PET in combination with MRI for the diagnosis of prostate cancer in the pre-biopsy setting, completed enrollment of 350 patients. Rapid enrollment underscores the unmet need for a minimally invasive option for prostate cancer diagnosis. The study builds on the clinical foundation established by the PRIMARY23 and PRIMARY224 studies and is intended to support regulatory submissions. The FDA has supported an NDA pathway that could facilitate reimbursement and granted Fast Track Designation, which may enable an expedited review.

With enrollment complete in the Phase 3 registrational study of TLX591-Px (Illuccix) in Japan25, Telix is preparing for NDA submission and potential market entry. A Conditional Approval is currently under review by Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and is expected to facilitate an expedited review process.

TLX101-Px (floretyrosine F 18) for brain cancer imaging:

Telix’s Marketing Authorization Application (MAA) for Pixlumi26 in Europe remains under review.
Following the FDA clearance of the IND application, Telix is advancing a Phase 3 registrational study to support expansion of the Pixclara label for the diagnosis of brain metastases.

TLX250-Px, Zircaix27 (89Zr-girentuximab senvedoxam) for kidney cancer imaging:

Following receipt of the corrected Complete Response Letter (CRL), Telix is finalizing its Biologics License Application (BLA) resubmission package, addressing the remaining third-party manufacturing observations. Resubmission to the FDA is planned in the near term and remains a top priority for the Company in 2026.

Telix Manufacturing Solutions (TMS)

Through RLS, Telix has established a growing network of micro-pharmacy sites, known as UroOncRxTM, providing urologists with onsite access to our imaging agents, particularly in underserved and remote markets. Multiple sites are now operational and dispensing product, further strengthening our radiopharmacy infrastructure and expanding patient access.

ARTMS, a Telix company, has secured contracts for 50 QUANTM Irradiation Systems (QIS) globally, achieving a key commercial milestone and reflecting continued demand for its isotope production technology. Telix has also placed an order to purchase multiple cyclotrons from Ion Beam Application (IBA) where each cyclotron will be equipped with QIS technology.
Telix announced a collaboration with Ekalia28, a joint venture between IBA (Ion Beam Applications S.A., EURONEXT) and Framatome, to advance scalable U.S. production of astatine-211 (211At), an alpha-emitting radioisotope being investigated for targeted alpha therapy. The first IBA alpha-beam cyclotron installation at Telix’s RLS Radiopharmacies site in Trevose, near Philadelphia (PA) is intended to establish a reproducible production model, with the potential for further rollout across the RLS network as demand develops. The collaboration secures long-term, priority isotope access for Telix’s alpha therapy pipeline, while also supporting third-party academic and industry programs.

Corporate Updates

Telix announced a transformational merger with ITM, the world’s leading supplier of therapeutic radioisotopes, reinforcing its long-term strategy as a vertically integrated radiopharmaceutical company and further strengthening one of the industry’s broadest therapeutic pipelines. ITM brings a complementary late-stage portfolio led by ITM-11 (177Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as industry-leading isotope capabilities anchored by the only globally scaled commercial-grade 177Lu production platform. The transaction includes upfront consideration of US$1.65 billion on a cash-free, debt-free basis, with ITM shareholders expected to receive approximately US$1.25 billion in Telix shares released as ADRs. Additional contingent consideration of up to US$700 million may be paid upon achievement of future regulatory approvals and commercial sales milestones for ITM-11. The transaction remains subject to Telix shareholder approval and customary closing conditions. A General Meeting of Shareholders is expected to be held on December 1, 2026 (AEDT).

Mr. David Gill was appointed Chair of the Board on September 1, 202629. Mr. Gill is a life sciences executive with more than 35 years of experience in biopharma, radiopharmaceuticals and medical devices. He has held senior leadership positions, including President, Chief Operating Officer and Chief Financial Officer roles at multiple public companies, and brings extensive expertise in capital markets, governance, business scaling and corporate strategy. He currently serves on the boards of several healthcare companies and holds degrees from Wake Forest University and Emory University.

Mr. Marcin Firek will join Telix as Company Secretary, effective October 21, 2026. Mr. Firek brings extensive experience in corporate governance, legal affairs, risk management and public company administration, including for dual-listed Australian and U.S. companies. Most recently, he served as Head of Enterprise & Operational Risk at PwC Australia. Previously, he led the Company Secretary team at Woolworths Group Limited, ASX Limited and James Hardie Industries Plc. Earlier in his career, he practiced corporate and M&A law at MinterEllison. Mr. Firek will be the primary person responsible for communications with the ASX under ASX Listing Rule 12.6. Mr. Shomalin Naidoo has also ceased his appointment as interim Company Secretary effective today.

FY 2026 guidance

Telix expects FY 2026 revenue and other income to exceed US$1 billion, with revenue tracking toward the upper end of its FY 2026 guidance of US$950 million to US$970 million, including US$40 million in other reported income.
Revenue guidance reflects product sales in markets where marketing authorization has been granted, includes a full-year contribution from RLS, and incorporates anticipated sales of Pixclara.
Telix revises its FY 2026 R&D expenditure guidance range to US$240 million to US$260 million, previously US$230 million to US$270 million, subject to the achievement of planned clinical, regulatory and development milestones.

(Press release, Telix Pharmaceuticals, OCT 21, 2026, View Source [SID1234673610])

On October 20, 2026 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma")) reported that UNLOXCYT (cosibelimab-ipdl) has been elevated to a National Comprehensive Cancer Network (NCCN) Category 2A recommended option for patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) who are not candidates for curative surgery or curative radiation.

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This is an addition to the Category 2A designation in metastatic cutaneous squamous cell carcinoma (mCSCC), which was assigned to UNLOXCYT in 2025.

UNLOXCYT was approved by the U.S. Food and Drug Administration (FDA) in 2024 and is indicated for the treatment of adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation. The recommended dosage of UNLOXCYT is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks. UNLOXCYT is the first and only FDA-approved PD-L1-blocking antibody for advanced CSCC (aCSCC).

The evidence submitted to NCCN in support of the change was based on the pivotal registration study, in which 55% of patients achieved an objective response, including 26% who achieved a complete response. Responses were durable: at a median follow-up of 24.1 months; median duration of response had not been reached (range: 8.3 to 31.3+ months). In addition, fewer than 1% of patients experienced a high-grade (Grade 3-5) immune-mediated adverse reaction (imARs)—an important consideration in this patient population. There were no grade 4 or 5 imARs.

"The NCCN Guidelines play an important role in helping physicians evaluate appropriate treatment options for patients across different disease settings," said Ahmad Naim, MD, Senior Vice President, North American Chief Medical Officer, Sun Pharma. "The elevation of UNLOXCYT to a Category 2A recommendation for patients with laCSCC marks an important milestone, validating the growing body of clinical evidence supporting UNLOXCYT and reflecting increasing confidence among oncology experts in its role as a treatment option for patients with this challenging disease."

NCCN is an alliance of 34 leading cancer centers in the U.S. Its Clinical Practice Guidelines in Oncology, referred to as the NCCN Guidelines, provide recommendations for the prevention, diagnosis, evaluation, and treatment of different types of cancer. The NCCN Guidelines are among the most influential clinical guidelines in cancer care, offering evidence-based, expert-developed recommendations intended to help clinicians make treatment decisions for patients with cancer.

One such expert clinician is Dr. Francis Worden, Clinical Professor of Internal Medicine at the University of Michigan Rogel Cancer Center, whose institution is one of the 34 NCCN member cancer centers in the alliance.

Dr. Worden said, "This guideline update reflects the strength of the published evidence supporting the use of UNLOXCYT as first line treatment for laCSCC. In the pivotal study, patients experienced durable and clinically meaningful responses. UNLOXCYT also demonstrated a low incidence of high-grade imARs—an important consideration when selecting immune checkpoint inhibitor therapy for a patient population that is mainly elderly and is often afflicted with other health issues. These clinical outcomes may be explained by the mechanism of action that restores adaptive immunity, engages innate immunity through antibody-dependent cellular cytotoxicity (ADCC), and preserves PD-L2 signaling that may be linked to the presence of some immune tolerance in non-tumor tissues."

NCCN Guidelines also have a meaningful impact on patient access because they inform payer coverage policies, prior-authorization criteria, institutional formularies, and clinical pathways.

"For patients with laCSCC—many of whom are older, medically complex, and vulnerable to treatment-related complications—access to a therapy that offers durable responses together with a low rate of high-grade imARs is especially important. NCCN recognition helps ensure that appropriate patients can receive this treatment up front without unnecessary access barriers," said Mark Gimbert, Senior Vice President, Head of Market and Patient Access, North America, Sun Pharma.

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (CSCC) is among the most common skin cancers worldwide. While early stages are treatable, an estimated 40,000 US patients each year progress to advanced disease, resulting in nearly 15,000 deaths.

Important risk factors for CSCC include chronic ultraviolet radiation exposure and immunosuppressive conditions. In addition to being life threatening, CSCC causes significant functional morbidities and cosmetic deformities due to tumors that commonly arise in the head and neck region and that invade blood vessels, nerves, and vital organs such as the eye or ear.

(Press release, Sun Pharma, OCT 20, 2026, https://www.prnewswire.com/news-releases/sun-pharma-announces-unloxcyt-cosibelimab-ipdl-has-received-a-category-2a-preferred-designation-in-the-updated-nccn-guidelines-for-locally-advanced-cutaneous-squamous-cell-carcinoma-lacscc-patients-who-are-not-candidates-for–302914405.html [SID1234673646])

On October 20, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical-stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported the advancement of ACR-7280, a potential first-in-class, oral CDK11 inhibitor, as its next development candidate generated from its AI-enabled AP3 innovation platform. Investigational New Drug (IND)-enabling studies are underway, and the company remains on track to submit an IND to the U.S. Food and Drug Administration (FDA) in the first half of 2027.

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ACR-7280 was prioritized from multiple series of CDK11 inhibitor compounds the company identified through its co-crystallography and AP3-driven discovery platform. AP3-based indication finding identified acute myeloid leukemia (AML) as a predicted sensitive tumor type, and ACR-7280 has shown complete tumor regression in in vivo AML xenograft models. Moreover, it has demonstrated potent preclinical anti-tumor activity across AML models, including NPM1-mutated and KMT2A-rearranged tumors, as well as strong synergy in combination with both venetoclax and menin inhibitors across several AML models. Based on this, initial development will focus on AML, both as single agent and in combination.

"ACR-7280 provides another powerful validation of our AP3 innovation engine," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. "AP3 profiling and analyses enabled us to identify ACR-7280 as a highly selective CDK11 inhibitor with optimized, desirable cellular pathway effects, which has translated to complete tumor regression in aggressive AML mouse models. While CDK11 has historically been a difficult target to drug, we believe ACR-7280 provides a first-in-class opportunity with broad potential in refractory/relapsed AML. The oral administration route may also provide flexibility for combining with standard-of-care agents, like venetoclax and menin inhibitors, potentially in earlier line settings. We look forward to advancing ACR-7280 swiftly towards the clinic, with IND submission on track for the first half of 2027."

CDK11 is a challenging but compelling target with multiple isoforms and broad roles in cell cycle control, spanning transcription, pre-mRNA splicing and mitosis. ACR-7280 was rationally designed using the AP3 platform to achieve optimal on-target pathway effects, the same approach that was used to design ACR-2316, the company’s potential first-in-class, oral WEE1/PKMYT1 inhibitor which was rapidly advanced to the randomized dose expansion phase of its Phase 1/2 study.

(Press release, Acrivon Therapeutics, OCT 20, 2026, View Source [SID1234673633])

On October 20, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that lisaftoclax (APG-2575), the Company’s novel Bcl-2 inhibitor, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), in combination with acalabrutinib, for the treatment of treatment-naïve adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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BTDs are granted to innovative drugs or modified new drugs intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impair quality of life, for which there is no effective treatment, or where sufficient existing evidence demonstrates significant clinical advantages over currently available treatment options. Drug candidates that are granted BTDs receive priority from the CDE for communications and development guidance to accelerate drug development. Furthermore, if the applicant meets the relevant conditions after evaluation, it may apply for Priority Review status and conditional approval when submitting a New Drug Application (NDA) in China. Overall, the BTD pathway is designed to accelerate the development and review of innovative drugs and modified new drugs that offer significant clinical value or address urgent unmet clinical needs.

CLL/SLL is a clonal proliferative malignancy of B lymphocytes that predominantly affects older adults, with more than 100,000 new cases worldwide each year.1 In recent years, the incidence of CLL/SLL in China has been increasing, with some patients presenting at a younger age and with more aggressive disease.2

In CLL/SLL, immunochemotherapy and BTK inhibitors have been used as first-line treatment options and have achieved favorable response rates and survival outcomes, although certain limitations remain. Immunochemotherapy has limited efficacy in some patients, particularly in those with high-risk features such as del(17p)/TP53 mutations, complex karyotypes, and unmutated IGHV. BTK inhibitor monotherapy, which is an approved standard of care treatment, also has limitations, including insufficient depth of response and concerns regarding long-term safety, and requires continuous treatment. Once treatment fails, patients have very limited subsequent treatment options, with generally poor outcomes. Therefore, there remains an urgent clinical need for fixed-duration combination strategies that improve efficacy and depth of response while reducing adverse events.

Lisaftoclax is a novel, oral, selective Bcl-2 inhibitor developed by Ascentage Pharma. In July 2025, lisaftoclax was approved in China for the treatment of adult patients with CLL/SLL who had previously received at least one systemic therapy including a BTK inhibitor. Lisaftoclax is the first China-developed Bcl-2 inhibitor approved in China and the second Bcl-2 inhibitor approved globally. Ascentage Pharma is currently conducting four global registrational Phase III trials of lisaftoclax. One of these studies, GLORA-2, is a global registrational Phase III trial evaluating the clinical potential of lisaftoclax in combination with acalabrutinib as a first-line treatment for CLL/SLL.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "This BTD recognizes the clinical potential of Lisaftoclax in combination with acalabrutinib for patients with treatment-naïve CLL/SLL and the urgent unmet need in this setting. Moving forward, we are continuing to accelerate the global clinical development of lisaftoclax across relevant indications and are striving to bring this treatment to more patients as quickly as possible."

(Press release, Ascentage Pharma, OCT 20, 2026, View Source [SID1234673632])