Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

On January 22, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, met its overall survival (OS) primary endpoint.

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In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004). The median OS for patients receiving relacorilant was 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months. Relacorilant in combination with nab-paclitaxel was well-tolerated, consistent with its known safety profile. Importantly, the type, frequency and severity of adverse events in the combination arm were comparable to those in the nab-paclitaxel monotherapy arm. Relacorilant conferred its benefit without increasing the safety burden of the patients who received it.

Corcept previously announced that ROSELLA also met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). Patients who received relacorilant in addition to nab-paclitaxel experienced a 30 percent reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.008). Findings were first presented at ASCO (Free ASCO Whitepaper) 2025 (American Society of Clinical Oncology) with simultaneous publication in The Lancet. Complete results from ROSELLA will be presented at an upcoming medical conference.

"The addition of relacorilant to nab-paclitaxel, a trusted and effective chemotherapy, is positioned to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer, due to its overall survival benefit, well tolerated side effect profile and oral administration. Importantly, the Phase 3 trial results are not limited to patients with any particular biomarker requirement," said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator in the ROSELLA trial. "ROSELLA’s findings compel us to evaluate relacorilant as a treatment for earlier stages of ovarian cancer and for other tumors that express the glucocorticoid receptor, such as endometrial and cervical cancer." Corcept is currently studying relacorilant in other solid tumors, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers.

"These data clearly demonstrate the potential of relacorilant plus nab-paclitaxel to extend overall and progression-free survival in patients with advanced, recurrent ovarian cancer," said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X in Milan, and Full Professor of Obstetrics and Gynaecology at Humanitas University, Rozzano and an investigator in the ROSELLA trial. "These tumors eventually become resistant to chemotherapy and providing oncologists with relacorilant plus nab-paclitaxel could greatly benefit patients."

"We want to thank the patients and investigators who participated in the ROSELLA trial. We are working with regulatory authorities in the U.S. and Europe to bring this much-needed new treatment to patients as soon as possible," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and endometrial, cervical, pancreatic and prostate cancers. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns six months after receiving platinum-containing therapy have "platinum-sensitive" disease and those with disease progression of less than six months have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease and 13,000 women with platinum-sensitive disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

(Press release, Corcept Therapeutics, JAN 22, 2026, https://ir.corcept.com/news-releases/news-release-details/overall-survival-primary-endpoint-met-corcepts-pivotal-phase-3 [SID1234662162])

Abbott Reports Fourth-Quarter and Full-Year 2025 Results; Issues 2026 Financial Outlook

On January 22, 2026 Abbott (NYSE: ABT) reported financial results for the fourth quarter ended Dec. 31, 2025.

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Fourth-quarter sales increased 4.4 percent on a reported basis, 3.0 percent on an organic basis, or 3.8 percent when excluding COVID-19 testing-related sales1.
Fourth-quarter GAAP diluted EPS of $1.01 and adjusted diluted EPS of $1.50, which excludes specified items and reflects growth of 12 percent.
Full-year 2025 sales of $44.3 billion increased 5.7 percent on a reported basis, 5.5 percent on an organic basis, or 6.7 percent when excluding COVID-19 testing-related sales2.
Full-year 2025 GAAP diluted EPS of $3.72 and adjusted diluted EPS of $5.15, which excludes specified items and reflects growth of 10 percent.
Abbott projects full-year 2026 organic sales growth to be in the range of 6.5% to 7.5%.
Abbott projects full-year 2026 adjusted diluted EPS of $5.55 to $5.80, which reflects growth of 10 percent at the midpoint.
In November, Abbott announced an agreement to acquire Exact Sciences, a move that will position the company to enter and lead in the fast-growing cancer diagnostics market. Abbott continues to expect the transaction to close in the second quarter of 2026.
Abbott expanded its leadership in Electrophysiology with two significant regulatory approvals:
In December, Abbott announced U.S. Food and Drug Administration (FDA) approval for its Volt PFA System, bringing Abbott’s first pulsed field ablation (PFA) offering to patients in the United States.
In January, Abbott announced the company obtained CE Mark for its TactiFlex Duo Ablation Catheter, Sensor Enabled, designed to deliver radiofrequency (RF) and PFA energy to treat patients battling atrial fibrillation.
"In 2025, we expanded margins and achieved double-digit earnings per share growth, our new product pipeline was highly productive, and we took important strategic steps to shape the company for the future," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re well positioned for accelerating growth in 2026."

FOURTH-QUARTER BUSINESS OVERVIEW

Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand the underlying performance of the company as the demand for COVID-19 tests has significantly declined following the transition from a pandemic to endemic phase.

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.

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,383

806

967

2,605

International

7,076

1,134

1,490

1,382

3,070

Total reported

11,459

1,940

2,457

1,382

5,675

% Change vs. 4Q24

U.S.

0.9

(13.2)

(8.4)

n/a

10.7

International

6.7

(5.6)

1.8

9.0

13.7

Total reported

4.4

(8.9)

(2.5)

9.0

12.3

Impact of foreign exchange

1.4

0.2

1.1

2.0

1.9

Organic

3.0

(9.1)

(3.6)

7.0

10.4

Impact of COVID-19 testing sales 1

(0.8)

(3.4)

Organic (excluding COVID-19 tests)

3.8

(9.1)

(0.2)

7.0

10.4

Organic

U.S.

0.9

(13.2)

(8.4)

n/a

10.7

International

4.3

(5.9)

(0.2)

7.0

10.1

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

17,126

3,606

3,535

9,968

International

27,202

4,845

5,402

5,536

11,419

Total reported

44,328

8,451

8,937

5,536

21,387

% Change vs. 12M24

U.S.

4.9

(2.3)

(7.7)

n/a

13.4

International

6.1

2.6

(2.0)

6.6

12.0

Total reported

5.7

0.4

(4.3)

6.6

12.6

Impact of foreign exchange

0.2

(0.7)

0.2

(0.8)

0.7

Impact of business exit*

(0.1)

Organic

5.5

1.2

(4.5)

7.4

11.9

Impact of COVID-19 testing sales 2

(1.2)

(4.9)

Organic (excluding COVID-19 tests)

6.7

1.2

0.4

7.4

11.9

Organic

U.S.

5.0

(1.9)

(7.7)

n/a

13.4

International

5.9

3.7

(2.3)

7.4

10.5

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Nutrition

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

806

463

343

International

1,134

439

695

Total reported

1,940

902

1,038

% Change vs. 4Q24

U.S.

(13.2)

(17.7)

(6.3)

International

(5.6)

0.3

(8.9)

Total reported

(8.9)

(9.8)

(8.1)

Impact of foreign exchange

0.2

0.3

0.1

Organic

(9.1)

(10.1)

(8.2)

U.S.

(13.2)

(17.7)

(6.3)

International

(5.9)

(0.3)

(9.1)

Worldwide Nutrition sales decreased 8.9 percent on a reported basis and 9.1 percent on an organic basis in the fourth quarter.

Results in the quarter reflect the impact of lower sales volumes compared to the prior year and new strategic price actions targeted to increase volume growth in the future. In addition to these strategic price actions, Abbott expects to increase volume growth with the launch of several new products in 2026.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Pediatric

Adult

U.S.

3,606

2,158

1,448

International

4,845

1,816

3,029

Total reported

8,451

3,974

4,477

% Change vs. 12M24

U.S.

(2.3)

(2.3)

(2.2)

International

2.6

0.1

4.1

Total reported

0.4

(1.2)

2.0

Impact of foreign exchange

(0.7)

(0.5)

(0.7)

Impact of business exit*

(0.1)

(0.3)

Organic

1.2

(0.7)

3.0

U.S.

(1.9)

(2.3)

(1.4)

International

3.7

1.3

5.1

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Diagnostics

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid Diagnostics

U.S.

967

376

39

107

445

International

1,490

1,085

102

51

252

Total reported

2,457

1,461

141

158

697

% Change vs. 4Q24

U.S.

(8.4)

3.6

2.9

6.5

(19.7)

International

1.8

5.9

3.3

9.8

(14.1)

Total reported

(2.5)

5.3

3.2

7.5

(17.8)

Impact of foreign exchange

1.1

1.7

2.1

0.4

0.3

Organic

(3.6)

3.6

1.1

7.1

(18.1)

U.S.

(8.4)

3.6

2.9

6.5

(19.7)

International

(0.2)

3.6

0.4

8.3

(14.9)

Global Diagnostics sales decreased 2.5 percent on a reported basis, decreased 3.6 percent on an organic basis, and decreased 0.2 percent when excluding COVID-19 testing-related sales1.

COVID-19 testing-related sales were $89 million in the quarter, compared to $176 million in the fourth quarter of the prior year.

Global Core Laboratory Diagnostics sales increased 5.3 percent on a reported basis and increased 3.6 percent on an organic basis. Growth in other geographies was partially offset by challenging market conditions in China, including the impact of volume-based procurement programs.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid Diagnostics

U.S.

3,535

1,425

150

422

1,538

International

5,402

3,935

367

184

916

Total reported

8,937

5,360

517

606

2,454

% Change vs. 12M24

U.S.

(7.7)

7.0

0.4

3.4

(20.8)

International

(2.0)

0.8

(1.1)

2.5

(13.3)

Total reported

(4.3)

2.4

(0.7)

3.1

(18.1)

Impact of foreign exchange

0.2

0.3

0.5

(0.1)

Organic

(4.5)

2.1

(1.2)

3.1

(18.0)

U.S.

(7.7)

7.0

0.4

3.4

(20.8)

International

(2.3)

0.4

(1.8)

2.4

(13.1)

Established Pharmaceuticals

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

International

1,382

1,046

336

Total reported

1,382

1,046

336

% Change vs. 4Q24

U.S.

n/a

n/a

n/a

International

9.0

10.3

5.0

Total reported

9.0

10.3

5.0

Impact of foreign exchange

2.0

1.6

3.1

Organic

7.0

8.7

1.9

U.S.

n/a

n/a

n/a

International

7.0

8.7

1.9

Established Pharmaceuticals sales increased 9.0 percent on a reported basis and 7.0 percent on an organic basis in the fourth 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 10.3 percent on a reported basis and 8.7 percent on an organic basis, led by double-digit growth in India and several countries across Latin America and the Middle East.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

International

5,536

4,167

1,369

Total reported

5,536

4,167

1,369

% Change vs. 12M24

U.S.

n/a

n/a

n/a

International

6.6

8.0

2.5

Total reported

6.6

8.0

2.5

Impact of foreign exchange

(0.8)

(1.5)

1.1

Organic

7.4

9.5

1.4

U.S.

n/a

n/a

n/a

International

7.4

9.5

1.4

Medical Devices

Fourth Quarter 2025 Results (4Q25)

Sales 4Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,605

340

340

283

287

304

208

843

International

3,070

365

390

92

496

371

66

1,290

Total reported

5,675

705

730

375

783

675

274

2,133

% Change vs. 4Q24

U.S.

10.7

12.8

13.1

11.7

6.5

4.8

1.9

14.9

International

13.7

13.4

13.9

17.9

8.9

16.3

23.8

14.2

Total reported

12.3

13.1

13.5

13.2

8.0

10.8

6.5

14.5

Impact of foreign exchange

1.9

1.6

1.0

1.1

1.5

2.1

0.9

2.8

Organic

10.4

11.5

12.5

12.1

6.5

8.7

5.6

11.7

U.S.

10.7

12.8

13.1

11.7

6.5

4.8

1.9

14.9

International

10.1

10.2

11.9

13.4

6.6

12.3

19.6

9.6

Worldwide Medical Devices sales increased 12.3 percent on a reported basis and 10.4 percent on an organic basis in the fourth quarter.

Sales growth in the quarter was led by double-digit growth in Electrophysiology, Heart Failure, Diabetes Care, and Rhythm Management.

In Diabetes Care, sales of continuous glucose monitors were $2.0 billion and grew 15.0 percent on a reported basis and 12.2 percent on an organic basis.

Full-Year 2025 Results (12M25)

Sales 12M25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

9,968

1,334

1,283

1,107

1,118

1,172

773

3,181

International

11,419

1,315

1,481

341

1,877

1,351

237

4,817

Total reported

21,387

2,649

2,764

1,448

2,995

2,523

1,010

7,998

% Change vs. 12M24

U.S.

13.4

15.7

12.4

12.2

5.8

11.5

0.8

20.8

International

12.0

6.4

11.7

16.4

5.4

13.0

21.5

15.4

Total reported

12.6

10.9

12.0

13.2

5.6

12.3

5.0

17.5

Impact of foreign exchange

0.7

0.7

0.4

0.5

0.5

0.8

0.2

1.2

Organic

11.9

10.2

11.6

12.7

5.1

11.5

4.8

16.3

U.S.

13.4

15.7

12.4

12.2

5.8

11.5

0.8

20.8

International

10.5

5.0

10.9

14.3

4.7

11.5

20.5

13.5

(Press release, Abbott, JAN 22, 2026, View Source [SID1234662161])

Entry into a Material Definitive Agreement

On January 21, 2026 Autolus Limited, a wholly owned subsidiary of Autolus Therapeutics plc (the "registrant", and together with Autolus Limited, the "Company"), reported to have entered into a Master Service Agreement with AGC Biologics S.p.A ("AGC") for the manufacture and supply of lentiviral vector (the "Agreement"), a raw material which is critical for the Company’s manufacture of CAR-T products for clinical and commercial use. The Agreement replaces and supersedes the prior arrangement between the Company and AGC, pursuant to which AGC has provided similar products and services.

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The Agreement sets forth the general terms and conditions applicable to AGC’s provision of products and services to the Company; specific projects will be set forth in individual work orders executed separately by the parties. The Agreement contains customary provisions regarding order placement and fulfillment, governance, regulatory support, change management, risk allocation, intellectual property, and confidentiality. The Agreement runs for a fixed term of ten years, and may be terminated by either party for default, or by the Company upon written notice (subject, in the latter case, to the payment of certain fees by the Company). The Agreement is non-exclusive with respect to each party. However, under the Agreement and the initial statement of work thereunder, the Company has committed to purchase a minimum of 14 batches of lentiviral vector during the first two calendar years of the term, and to purchase a minimum value of EUR 25 million of products and services during the subsequent five-year period. The Agreement also provides AGC with the first right to negotiate with the Company regarding the provision of new manufacturing activities in relation to the Company’s obecabtagene autoleucel, or obe-cel, product.

The foregoing summary of the material terms of the Master Service Agreement does not purport to be complete and is qualified in its entirety by reference to such Master Service Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2026. Portions of the Agreement may be omitted pursuant to Item 601(b)(10)(iv) or Item 601(a)(5) of Regulation S-K under the Securities Exchange Act of 1934, as amended.

(Filing, 8-K, Autolus, JAN 21, 2026, View Source [SID1234662203])

Research to expand options for hard-to-treat cancers

On January 21, 2026 Researchers at FIU reported a personalized approach to cancer treatment that is showing increasingly promising results for patients with hard-to-treat disease, supported by new philanthropic investment that is helping expand the science behind the work.

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A recent gift from the Tyler Trent Foundation is accelerating research led by Diana Azzam, whose lab is pioneering functional precision medicine — an emerging strategy that identifies the most effective therapies by testing large libraries of drugs directly on living tumor cells from individual patients.

The support comes as preliminary findings from the next phase of Azzam’s clinical research indicate even stronger responses than those observed in her original study, reinforcing the potential of drug sensitivity testing to guide treatment decisions when standard approaches fail.

"Cancer remains one of the leading causes of death, and many patients eventually run out of effective treatment options," Azzam said. "What we’re seeing in our latest work suggests that functional testing can reveal opportunities that traditional methods may miss."

Beyond genetics alone

Unlike conventional precision oncology, which relies primarily on genetic mutations to guide care, functional precision medicine evaluates how a patient’s cancer actually responds to hundreds of existing drugs. Tumor cells grown from patient samples are exposed to a wide range of compounds, allowing researchers to observe real-time drug sensitivity and resistance.

In earlier clinical research, this approach generated treatment recommendations for all participants, with many patients experiencing improved outcomes. Early data from the newest clinical phase suggest that expanding the range of drugs tested may further enhance both the effectiveness and speed of identifying viable therapies.

The method has drawn particular interest for patients with recurrent or treatment-resistant cancers, including cases where genomic testing reveals few actionable mutations.

"Our goal is to find the right drug for the right person at the right time," Azzam said. "Functional testing gives us another powerful tool to do that."

Expanding the search for effective treatments

The Tyler Trent Foundation’s gift will allow Azzam’s lab to expand its library of FDA-approved generic medications and natural compounds — a carefully curated collection of safe, widely available molecules. Many of these compounds, originally developed as antibiotics, antifungals or antiparasitic, have shown unexpected promise in cancer research and may be repurposed for oncological use.

By focusing on medications with established safety profiles, results from this study are expected to support their earlier introduction in treatment, particularly when they demonstrate synergistic effects with standard therapies. This approach could allow lower doses of conventional chemotherapy to be used, helping reduce toxicity while maintaining or enhancing treatment effectiveness and accelerating the translation from laboratory discovery to patient care.

"When we identify a drug that works, it’s often something physicians already know how to prescribe," Azzam said. "That significantly increases the potential for rapid clinical impact."

A legacy driving discovery

The Tyler Trent Foundation was established in memory of Tyler Trent, who died from osteosarcoma, a rare bone cancer. During his illness, Tyler became known nationally for his optimism and advocacy, using his platform to encourage support for cancer research. His legacy has helped raise millions of dollars to advance cancer science and patient care.

(Press release, Florida International University, JAN 21, 2026, View Source [SID1234662151])

Arcellx to Advance the Conversation on Its Platform and the Importance of Early CAR T Access for Patients with Multiple Myeloma During the 2026 Tandem Meetings

On January 21, 2026 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, ireported both its scientific foundation for its D-Domain platform technology and commercial preparedness for anito-cel for the potential treatment of multiple myeloma with three presentations at the 2026 Tandem Meetings. One presentation reinforces anito-cel’s unique ability to transiently engage BCMA, potentially resulting in tumor cell clearance without prolonged inflammation and providing a mechanistic rationale for the clinically differentiated efficacy and safety profile observed with anito-cel for multiple myeloma. Additionally, two new research studies are being presented, one on health economics and one on treatment sequencing outcomes. The meetings will be held February 4-7, 2026, at the Salt Palace Convention Center in Salt Lake City, Utah. Anito-cel is partnered with Kite, a Gilead Company.

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Tandem Presentation Details
Title and ID: Anito-cel’s D-Domain Binder Has a Fast Off-Rate and Contributes to Its Differentiated Pharmacology Profile in Multiple Myeloma (abstract ID: 28119)
Speaker: Kevin C. Hart, PhD
Session: Engineered Immune Cells (CAR-T, NK, TCR): Basic/Preclinical – Antigen Finding, Safety
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

Title and ID: Impact of Treatment Sequencing with CAR T-cell Therapies and Bispecific Antibodies on Long-Term Survival in 4L+ RRMM in the U.S.: A Simulation Model (abstract ID: 27320)
Speaker: Jodi Lipof, MD
Session: Engineered Immune cells – clinical (toxicity, practice, economics, correlative, autoimmunity, malignant, and non-malignant indications)
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

Title and ID: Visualizing Geographic Variation and Systemic Inequities of Disease Burden and CAR T-cell Therapy Access in Multiple Myeloma in the U.S. (abstract ID: 27927)
Speaker: Brandon Blue, MD
Session: Health Services and Barriers to Access
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

About Multiple Myeloma

Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About Anitocabtagene Autoleucel (anito-cel)

Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Arcellx, JAN 21, 2026, View Source [SID1234662149])