enGene to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 enGene Holdings Inc. (Nasdaq: ENGN or "enGene"), a clinical-stage, non-viral genetic medicines company, reported that Ron Cooper, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11, 2026, at 2:30 p.m. ET.

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A live webcast of the fireside chat can be accessed on the "Events and Presentations" page under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

(Press release, enGene, FEB 4, 2026, View Source [SID1234662490])

Arcellx Announces Late-Breaking Presentation at TANDEM Demonstrating Unique, High Target-Specificity of anito-cel’s D-Domain Binder

On February 4, 2026 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases, reported that a late-breaking abstract for its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) has been accepted for presentation at the 2026 Tandem Meetings. BCMA-directed CAR T therapies are effective in treating relapsed and/or refractory multiple myeloma, with the potential for deep and durable responses. Anito-cel is partnered with Kite, a Gilead Company.

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The poster (903) describes a preclinical study that explores the role of binder attributes in the specificity of BCMA-directed CAR T cells. CAR constructs representative of cilta-cel (dual VHH), ide-cel (scFv), and anito-cel (D-Domain) were assessed preclinically. In summary, the results showed no tonic signaling or off-target activity with the D-Domain binder, supporting a favorable safety profile. CAR T activation and cytokine release, reflective of tonic signaling, were observed for dual VHH and scFv binders in the absence of BCMA antigen, but not with the D-Domain. Off-target activity, specifically against Claudin-9 (CLDN9), was observed with the dual VHH binder, and no off-target activity was observed with the scFv binder or the D-Domain. Claudin-9 is a member of the Claudin family and is expressed at the tight junctions of endothelial and epithelial barriers. Therefore, binding of CLDN9 in addition to BCMA could increase the risk of off-target toxicities. Claudin family proteins have been implicated in maintaining the structural and functional integrity of the blood–brain and gut–vascular barriers, and disrupted Claudin function is linked to inflammatory, neurodegenerative, and gut disorders.

The Tandem Meetings are being held February 4-7, 2026, at the Salt Palace Convention Center in Salt Lake City, Utah. A copy of the presentation can be accessed on Arcellx’s website at www.arcellx.com under the Pipeline/Scientific publications section.

Tandem Presentation Details
Title and ID: D-Domain Binder In Anitocabtagene Autoleucel Shows Absence of Tonic Signaling and Cross-Reactivity Profile (poster ID: 903) (abstract: 29612)
Speaker: Alexandra Witter, PhD
Session: Poster Session: Late-Breaking Poster Abstracts
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

Abstract Details

Title
D-Domain Binder in Anitocabtagene Autoleucel Confers Potent Anti-Tumor Activity while Minimizing Tonic Signaling and Off-Target Reactivity

Authors
Alexandra Witter, Lawrence P. Andrews, Matthew J. Frigault, Krina K. Patel, Ciara L. Freeman, Sigal Shachar

Introduction
BCMA-directed CAR-T cell therapies are effective in treating relapsed and/or refractory multiple myeloma, with potential for deep and durable responses. Anitocabtagene autoleucel (anito-cel) has demonstrated an encouraging efficacy and safety profile, with no cases of delayed neurotoxicities or immune effector cell-associated enterocolitis (IEC-EC) observed to date (Patel et al., ASH (Free ASH Whitepaper) 2025). This profile differentiation may be attributable to the different BCMA-targeting binders used in these CAR-T cell therapies, as current standard-of-care BCMA-directed CAR-T cell therapies either demonstrate suboptimal efficacy with idecabtagene vicleucel (ide-cel), or a risk of delayed toxicities such as parkinsonism, cranial nerve palsies or IEC-EC with ciltacabtagene autoleucel (cilta-cel). Anito-cel utilizes a novel synthetic D-Domain binder, with binding to BCMA characterized by a fast off-rate and displays minimal antigen-independent aggregation (Hart et al., ASH (Free ASH Whitepaper) 2025).

Objectives
This study aims to further explore the contribution of binder attributes towards specificity of BCMA-directed CAR-T cells.

Methods
We transduced CAR constructs representative of cilta-cel (dual VHH), ide-cel (scFv) and anito-cel (D-Domain) into healthy donor T cells. Key attributes such as phenotypes associated with tonic signaling and target-specific activity were compared between surrogate CAR-T cells with matched CAR-positive frequency and vector copy number.

Results
Dual VHH CAR-T cells show increased expression of FAS, ICAM and TRAIL, compared to D-Domain CAR-T cells, in the absence of antigen-expressing cells suggesting a tonic signaling phenotype. D-Domain CAR-T cells did not show expression of activation markers (CD69, 4-1BB) or IFNγ release, which were elevated 3-fold and 39-fold respectively, with dual VHH CAR-T cells. As previously reported from a membrane surface protein array, cilta-cel bound to Claudin-9 (CLDN9) in addition to BCMA (EPAR EMA/594558/2022, EMA 2022). CLDN9 is expressed in tight junctions of folliculo-stellate cells in the anterior pituitary gland and cerebellum. In this study, dual VHH CAR-T cells stimulated with CLDN9++ HEK293 cells demonstrated upregulation of activation markers, IFNγ release and target cell killing. CLDN9-induced activity was not observed with D-Domain or scFv CAR-T cells under any conditions tested.

Conclusion
Off-target activity with dual VHH CAR-T cells was seen against CLDN9, suggesting that the high avidity dual VHH binder could recognize other cryptic epitopes and lead to off-tumor binding and toxicities. The D-Domain exhibits favorable features such as stability and rapid off-rate differentiating it from the dual VHH binder, which may contribute to the enhanced target specificity and lack of tonic signaling described here.

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, FEB 4, 2026, View Source [SID1234662489])

Immunome to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Immunome management will present at Guggenheim’s Emerging Outlook: Biotech Summit on February 11, 2026, at 9 a.m. ET.

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Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

(Press release, Immunome, FEB 4, 2026, View Source [SID1234662488])

Boston Scientific announces results for fourth quarter and full year 2025

On February 4, 2026 Boston Scientific Corporation (NYSE: BSX) reported net sales of $5.286 billion during the fourth quarter of 2025, growing 15.9 percent on a reported basis, 14.3 percent on an operational1 basis and 12.7 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $672 million or $0.45 per share (EPS), compared to $566 million or $0.38 per share a year ago, and achieved adjusted3 EPS of $0.80 for the period, compared to $0.70 a year ago.

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For the full year 2025, the company generated net sales of $20.074 billion, growing 19.9 percent on a reported basis, 19.2 percent on an operational1 basis and 15.8 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $2.898 billion or $1.94 per share, compared to $1.853 billion or $1.25 per share a year ago, and delivered full year adjusted3 EPS of $3.06, compared to $2.51 a year ago.

"2025 was another exceptional year for Boston Scientific, with our global teams delivering differentiated innovation and high performance that enabled us to exceed our goals," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As a direct result of the dedication, consistency and winning spirit of our team, we have impacted millions of patient lives and are well-positioned to continue on our strong growth trajectory well into the future."

Fourth quarter financial results and recent developments:

Reported net sales of $5.286 billion, representing an increase of 15.9 percent on a reported basis, compared to the company’s guidance range of 14.5 to 16.5 percent; 14.3 percent on an operational basis; and 12.7 percent on an organic basis, compared to the company’s guidance range of 11 to 13 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.45 per share, compared to the company’s guidance range of $0.48 to $0.52 per share, and achieved adjusted EPS of $0.80 per share, compared to the guidance range of $0.77 to $0.79 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 11.7 percent reported, 10.2 percent operational and 6.5 percent organic
Cardiovascular: 18.2 percent reported, 16.5 percent operational and 16.1 percent organic
Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 17.0 percent reported and operational
Europe, Middle East and Africa (EMEA): 12.4 percent reported and 4.8 percent operational
In the second quarter of 2025, management made the decision to discontinue worldwide sales of the ACURATE neo2 and ACURATE Prime Aortic Valve Systems, which had prior year global sales of approximately $50 million per quarter
Asia-Pacific (APAC): 15.2 percent reported and 14.8 percent operational
Latin America and Canada (LACA): 15.9 percent reported and 10.4 percent operational
Emerging Markets4: 15.4 percent reported and 13.0 percent operational
Received U.S. Food and Drug Administration (FDA) approval and CE mark for the FARAPOINT Pulsed Field Ablation (PFA) Catheter, a nav-enabled, focal PFA catheter that can create focal and linear-shaped lesions within a single device.
Commenced enrollment in the OPTIMIZE clinical trial, which uses the Cortex OPTIMAP Electrographic Flow (EGF) Mapping Technology with the FARAPULSE PFA Platform to evaluate how EGF-guided mapping and delivery of PFA to atrial fibrillation (AF) sources outside the pulmonary veins impacts outcomes for patients with persistent AF, compared to traditional anatomic approaches.
Completed enrollment in the SIMPLAAFY clinical trial evaluating two single-drug regimens as post-procedural alternatives to dual anti-platelet therapy following implantation of the WATCHMAN FLX Pro Left Atrial Appendage Closure Device in patients with AF.
Initiated U.S. launch of the SEISMIQ Intravascular Lithotripsy (IVL) System to treat patients with complex calcified peripheral artery disease.
Completed enrollment in the global FRACTURE IDE clinical trial evaluating the use of the SEISMIQ IVL System to treat patients with complex calcified coronary artery disease.
Received U.S. FDA 510(k) clearance for the TheraSphere 360 Y-90 Management Platform, a web-based platform that simplifies ordering TheraSphere Y-90 and helps care teams plan, dose and track the therapy for patients with liver cancer.
Received positive coverage for the Intracept Procedure from Health Care Service Corporation and launched the Intracept EDGE J Stylet, the latest advancement to the Intracept Procedure System, designed to improve access to the basivertebral nerve and streamline the treatment experience.
Commenced enrollment in the MOSAIC study, using commercially approved Boston Scientific Spinal Cord Stimulation (SCS) Systems, to evaluate the effectiveness of time variant pulse patterns of SCS and compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
Received U.S. coverage of Endoscopic Sleeve Gastroplasty (ESG), using the OverStitch Endoscopic Suturing System, by Elevance Health (formerly Anthem) beginning December 18, 2025, and recognition by The American Society for Metabolic and Bariatric Surgery of ESG as an endorsed procedure, expanding patient access to an innovative, less invasive weight-loss solution.
Received CE mark for the MOSES Raydar Holmium Laser System, which is designed to increase ablation efficiency by maintaining an effective proximity range between the laser fiber tip and kidney stone during lithotripsy procedures.
Announced agreement to acquire Penumbra, Inc., (NYSE: PEN) a publicly traded company that offers thrombectomy products for use in peripheral vascular procedures, minimally invasive peripheral embolization technologies and differentiated neurovascular solutions for access, stroke revascularization and neuro embolization – subject to customary closing conditions.
Announced agreement to acquire Valencia Technologies Corporation, a privately held company focused on the development and commercialization of the eCoin System, an implantable tibial nerve stimulation device for the treatment of urge urinary incontinence — subject to customary closing conditions.
Completed the acquisition of Nalu Medical, Inc., developer of the Nalu Neuromodulation System, designed to use peripheral nerve stimulation to deliver targeted relief for adults living with severe, intractable chronic pain of peripheral nerve origin.
1.

Operational net sales growth excludes the impact of foreign currency fluctuations.

2.

Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.

3.

Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4.

Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

Net sales for the fourth quarter by business and region:

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Certain
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2025

2024

Endoscopy

$ 760

$ 690

10.1 %

(1.9) %

8.2 %

— %

8.2 %

Urology

717

630

13.8 %

(1.1) %

12.7 %

(9.5) %

3.2 %

Neuromodulation

332

299

11.1 %

(1.2) %

9.9 %

— %

9.9 %

MedSurg

1,809

1,619

11.7 %

(1.5) %

10.2 %

(3.7) %

6.5 %

Cardiovascular

3,477

2,942

18.2 %

(1.7) %

16.5 %

(0.4) %

16.1 %

Net Sales

$ 5,286

$ 4,561

15.9 %

(1.6) %

14.3 %

(1.6) %

12.7 %

Increase/(Decrease)

Three Months Ended
December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2025

2024

U.S.

$ 3,385

$ 2,893

17.0 %

— %

17.0 %

EMEA

933

830

12.4 %

(7.6) %

4.8 %

APAC

788

684

15.2 %

(0.4) %

14.8 %

LACA

179

155

15.9 %

(5.5) %

10.4 %

Net Sales

$ 5,286

$ 4,561

15.9 %

(1.6) %

14.3 %

Emerging Markets4

$ 771

$ 668

15.4 %

(2.5) %

13.0 %

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of certain acquisitions/divestitures are not prepared in accordance with U.S. GAAP.

Net sales for the full year by business and region:

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational
Basis

Impact of
Certain
Acquisitions/
Divestitures

Organic
Basis

(in millions)

2025

2024

Endoscopy

$ 2,916

$ 2,687

8.6 %

(0.8) %

7.8 %

(0.1) %

7.7 %

Urology

2,709

2,200

23.1 %

(0.4) %

22.7 %

(17.9) %

4.7 %

Neuromodulation

1,199

1,106

8.4 %

(0.4) %

8.0 %

— %

8.0 %

MedSurg

6,824

5,993

13.9 %

(0.6) %

13.3 %

(6.6) %

6.7 %

Cardiovascular

13,250

10,755

23.2 %

(0.7) %

22.5 %

(1.6) %

20.8 %

Net Sales

$ 20,074

$ 16,747

19.9 %

(0.7) %

19.2 %

(3.4) %

15.8 %

Increase/(Decrease)

Year Ended

December 31,

Reported
Basis

Impact of
Foreign
Currency
Fluctuations

Operational

Basis

(in millions)

2025

2024

U.S.

$ 12,864

$ 10,210

26.0 %

— %

26.0 %

EMEA

3,451

3,228

6.9 %

(3.7) %

3.2 %

APAC

3,080

2,686

14.7 %

(0.2) %

14.5 %

LACA

678

624

8.7 %

2.0 %

10.7 %

Net Sales

$ 20,074

$ 16,747

19.9 %

(0.7) %

19.2 %

Emerging Markets4

$ 2,985

$ 2,680

11.4 %

0.2 %

11.6 %

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of certain acquisitions/divestitures are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and First Quarter 2026

The company estimates net sales growth for the full year 2026, versus the prior year period, to be approximately 10.5 to 11.5 percent on a reported basis and 10.0 to 11.0 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates adjusted EPS, excluding certain charges (credits), of $3.43 to $3.49.

The company estimates net sales growth for the first quarter of 2026, versus the prior year period, to be approximately 10.5 to 12.0 percent on a reported basis and 8.5 to 10.0 percent on an organic basis. First quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates adjusted EPS, excluding certain charges (credits), of $0.78 to $0.80.

The company has not provided reconciliations of the forward-looking adjusted EPS guidance to GAAP guidance as it is unable to predict with reasonable certainty and without unreasonable efforts the impact of certain items such as intangible asset impairment charges, acquisition-related charges, restructuring and restructuring-related charges and litigation-related charges. The combined impact of these items is uncertain, dependent on various factors and cannot be predicted with reasonable certainty, and could be material to our GAAP measures of financial results.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

(Press release, Boston Scientific, FEB 4, 2026, View Source [SID1234662487])

Aminex Therapeutics Announces Multiple Sites Activated for Phase 1b/2 Clinical Trial of Novel Investigational Cancer Treatment AMXT 1501 and DFMO in Patients with Breast Cancer or Melanoma

On February 4, 2026 Aminex Therapeutics, Inc., a private clinical-stage biotechnology company focused on developing novel therapies for rare and difficult-to-treat cancers, reported the initiation of a Phase 1b/2 clinical trial of AMXT 1501 in combination with difluoromethylornithine (DFMO) in patients with breast cancer or metastatic melanoma.

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"Initiating this study is an important milestone for Aminex and for patients facing advanced cancers with limited treatment options," said Mark Burns, PhD, Chief Scientific Officer and President of Aminex. "This trial builds on our foundation of pre- and early clinical data demonstrating the potential of AMXT 1501 plus DFMO to block the polyamine metabolism—a pathway that drives tumor growth and suppresses immune responses. We are advancing this program, in collaboration with leading investigators and pediatric oncologists, targeting eight tumor types."

The multicenter, open-label trial (NCT07287917) will evaluate the safety, tolerability and preliminary efficacy of oral AMXT 1501 in combination with oral DFMO together with standard of care in metastatic melanoma or in pre- and post-menopausal women with ER+ HER2- breast cancer who have progressed after prior therapies. The study will include safety and dose expansion cohorts.

In addition to this trial, Aminex is partnering with The Beat Childhood Cancer Consortium at Penn State College of Medicine on a randomized Phase 1/2 clinical trial of AMXT 1501 plus DFMO in pediatric patients with neuroblastoma, diffuse intrinsic pontine glioma, atypical teratoid rhabdoid tumor, embryonal tumor with multilayer rosettes, ewing sarcoma, and osteosarcoma. (NCT06465199) Aminex also recently announced the receipt of Orphan Drug Designation from the FDA for AMXT 1501 plus DFMO for the treatment of patients with neuroblastoma.

About AMXT 1501 and DFMO
AMXT 1501 is a novel polyamine transport inhibitor designed to block the uptake of polyamines, which are essential for tumor growth and survival. DFMO is an established inhibitor of polyamine biosynthesis. Together, the combination aims to comprehensively inhibit polyamine metabolism and tumor growth.

(Press release, Aminex Therapeutics, FEB 4, 2026, View Source [SID1234662486])