J&J expects a 2026 US launch of Icotrokinra, a first-in-class oral IL-23 peptide for moderate-to-severe psoriasis, following a July 2025 submission and ongoing head-to-head trials versus Stelara.
The Icotrokinra program has expanded into IBD with pivotal Phase III studies in Crohn’s disease and ulcerative colitis initiated to address the 5 million moderate-to-severe patients not on biologics.
Tremfya (guselkumab) records robust growth in psoriasis and psoriatic arthritis, delivering durable skin clearance and unique inhibition of structural damage in PsA, while capturing >50% of new IL-23 starts in ulcerative colitis and rapid subcutaneous adoption in Crohn’s disease.
J&J’s 4804 fixed-dose combination of golimumab and guselkumab shows promising Phase II efficacy and safety in bio-refractory Crohn’s, UC, and PsA, with full data review and pivotal planning underway for refractory populations in 2026.
Imavi, the first FcRn inhibitor approved for myasthenia gravis, demonstrates sustained IgG reduction over 24 weeks with extension to 60 weeks in adults, and ~33% of neurologists surveyed plan first-line use, underpinning a potential >$5 billion opportunity.

1 day ago

Transcript

J&J outlines immunology pipeline advances at Wolfe Research Healthcare Conference 2025

JNJ

Product Launch

M&A

New Projects/Investments

Icotrokinra, an oral IL-23 receptor inhibitor, was submitted in July 2025 with a 2026 US launch targeted; robust phase III data and head-to-head trials versus Stelara are underway alongside pivotal Crohn’s and ulcerative colitis studies.
Tremfya continues to grow with durable skin clearance in psoriasis and psoriatic arthritis; it accounts for >50% of new IL-23 starts in ulcerative colitis and is experiencing rapid adoption in Crohn’s with its subcutaneous induction option.
J&J 4804, a fixed-dose TNF/IL-23 combination for biologic-refractory IBD, completed phase IIb DUET studies in Crohn’s and colitis, with results expected in 2026.
Imavi, the first FcRn inhibitor in myasthenia gravis, delivers sustained IgG reduction and durable disease control; it achieved >90% access coverage and is projected to be a >$5 billion asset, with ~33% of neurologists indicating first-line interest.
In 2024, J&J acquired multiple assets targeting atopic dermatitis and respiratory diseases—IL-31, IL-13/TSLP bispecifics, and an oral STAT6 inhibitor—to address heterogeneous endotypes and pursue higher remission rates.

1 day ago

Transcript

Johnson & Johnson previews Icotrokinra launch and immunology pipeline at Wolfe Conference

JNJ

Product Launch

New Projects/Investments

Icotrokinra, a once-daily oral IL-23 receptor peptide, was submitted in the US in July and is expected to launch in 2026, supported by Phase III psoriasis data and ongoing head-to-head trials versus Stelara and upcoming IBD studies.
Tremfya continues to expand in psoriasis and psoriatic arthritis, uniquely inhibiting structural damage in PsA, capturing over 50% of new starts in ulcerative colitis, and seeing a Crohn’s launch that outpaces recent entrants with its subcutaneous induction option.
Imavi (FcRn inhibitor) demonstrated sustained IgG reduction and durable disease control in myasthenia gravis across adults and adolescents, with early neurologist surveys showing ~33% would use it first-line; it is projected to be a $5 billion+ asset.
In 2024, J&J strengthened its atopic dermatitis and respiratory pipeline through acquisitions of an IL-31 blocker (NM26), an IL-13/TSLP bispecific, and an oral STAT6 inhibitor, aiming to address disease endotypes and elevate remission rates.

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Transcript

Johnson & Johnson plans $3.05B acquisition of Halda Therapeutics

JNJ

M&A

Johnson & Johnson to acquire Halda Therapeutics for $3.05 billion in cash, aiming to expand its oncology pipeline.
Deal leverages Halda’s RIPTAC™ platform and lead candidate HLD-0915, an FDA fast-track clinical-stage oral therapy showing anti-tumor activity in metastatic castration-resistant prostate cancer.
Transaction expected to close in the coming months, pending customary regulatory approvals, enhancing J&J’s targeted cancer-treatment portfolio across solid tumors.
Underscores J&J’s strategic focus on advancing precision oncology, building on nearly two decades of innovation in prostate cancer and expanding into breast, lung, and other solid tumors.

1 day ago

Bloomberg

J&J presents Week 48 APEX study results for TREMFYA in psoriatic arthritis

JNJ

Phase 3b APEX data show TREMFYA delivered a 2.5-fold greater inhibition of structural joint damage versus placebo at Week 24, sustained through Week 48 by PsA-modified vdH-S score.
More than 50% of TREMFYA-treated patients (Q4W or Q8W) achieved ACR50 response by Week 48.
Placebo-to-TREMFYA switchers saw radiographic progression fall from 0.96 at baseline–Week 24 to 0.41 at Week 48, a 57% reduction in mean vdH-S score change.
Safety remained consistent with TREMFYA’s well-established profile, with no new safety signals through Week 48.
Results underpin J&J’s supplemental BLA submission to the FDA to include structural damage inhibition in TREMFYA’s label.

2 days ago

Press Release

Johnson & Johnson Vision outlines growth strategy at UBS Global Healthcare Conference 2025

JNJ

Product Launch

Johnson & Johnson Vision serves 40 million patients globally in a $35 billion vision market with mid-single-digit growth, split roughly 70% contact lenses (Acuvue) and 30% intraocular lenses (cataract surgery), and is delivering above-market performance through science-driven innovation.
Recent launches include the Acuvue Oasis One Day Maxx contact lens with advanced optics for comfort and visual disturbances and the Tecnis Odyssey (U.S.) and Tecnis Purity (ex-U.S.) premium intraocular lenses—both the fastest-growing PCIOLs in their regions, with global roll-outs planned early next year.
Capital allocation prioritizes R&D for unmet needs, manufacturing efficiencies via integrated business planning to match supply and demand, and data-driven commercialization to optimize patient acquisition and retention.
The organization leverages AI across clinical study design, supply chain optimization, and customer engagement, and is exploring drug-eluting contact lenses, underscoring integration with Johnson & Johnson’s broader pharmaceutical and medtech capabilities.

8 days ago

Transcript

J&J Vision outlines growth strategy at UBS Global Healthcare Conference 2025

JNJ

Product Launch

The vision segment grew 6% operationally in Q3, while surgical vision posted 13% growth in the same quarter, driven by market‐leading Acuvue and Tecnis portfolios.
Contacts represent 70% of the business and surgical 30%; J&J is expanding premium offerings with launches of Acuvue Oasis One Day Maxx, Tecnis Odyssey, and Tecnis Purity, with global rollouts planned in early 2026.
Cataract procedures remain 80% monofocal/20% premium globally; J&J has implanted 5 million Tecnis EyeHance monofocal lenses and is targeting growth from a 10–15% baseline premium mix.
The company leverages data and AI across R&D, manufacturing (via integrated business planning), and commercialization to optimize supply, streamline studies, and personalize patient engagement.
J&J Vision serves ~40 million patients today within a 2 billion-person addressable market, with presbyopia and astigmatism each affecting 50% of potential users.

8 days ago

Transcript

Johnson & Johnson Vision details growth and innovation at UBS Conference 2025

JNJ

Product Launch

The vision business delivered 6% operational growth in Q3, comprising 70% contact lenses and 30% surgical revenue, with above-market performance targeted through a strategic plan.
Key recent launches include ACUVUE OASYS 1-Day MAX for presbyopic astigmatism and Tecnis Odyssey/PureSee premium intraocular lenses, designed to enhance comfort and continuous range of vision.
Premium IOLs represent ~20% of global cataract procedures, and J&J is focused on increasing penetration via advanced optics and simplified surgeon onboarding.
The company is prioritizing global expansion and employing data and AI across R&D, manufacturing, and commercialization to sustain above-market growth.

8 days ago

Transcript

Johnson & Johnson outlines late‐stage pipeline and recent approvals at Guggenheim Healthcare Innovation Conference

JNJ

Product Launch

INLEXO approved for non-muscle invasive bladder cancer, yielding 82% complete responses in CIS and launched Sept 9 with seamless adoption across academic and community urologists.
RYBREVANT + Lazertinib is the leading chemo-free frontline EGFR+ NSCLC regimen by intent-to-prescribe and unaided awareness; subQ formulation will support deeper penetration and expansion into head & neck (45% ORR) and colorectal indications.
CARVYKTI CAR-T has treated 9,000+ patients in 14 countries, with 30% disease-free at five years (CARTITUDE-1) and over half of new patients coming from community centers.
Bispecifics Tecvayli and Talvey have reached 20,000+ patients globally; Tecvayli met PFS and OS endpoints versus daratumumab combos in Majestic-3 and is positioned for rapid community uptake.
JNJ-2113 oral TYK2 inhibitor filed for psoriasis (potential frontline systemic to expand a 60% untreated market) and entering phase 3 for IBD; Caplyta gained adjunctive MDD approval with 80% response and 65% remission at six months.

8 days ago

Transcript

Johnson & Johnson presents oncology and immunology pipeline progress

JNJ

Product Launch

Johnson & Johnson launched INLEXO for non-muscle invasive bladder cancer, showing 82% complete response in CISS patients and rapid community uptake post-September approval.
RYBREVANT with Lazertinib leads as the first chemo-free frontline lung cancer regimen, achieving highest intent-to-prescribe and preparing for subcutaneous formulation rollout.
CARVYKTI CAR-T therapy has treated over 9,000 patients, delivering 30% disease-free at five years and meeting growing global demand after resolving manufacturing constraints.
The Tecvayli bispecific has treated over 20,000 patients with low discontinuation rates, and the Majestic-3 study reported improved progression-free survival and overall survival for the TecDARA regimen.
Oral JNJ-2113 (go-to-Kindra) demonstrates complete skin clearance in psoriasis, poised to expand the systemic market, with Phase III ulcerative colitis and Crohn’s disease studies planned.

8 days ago

Transcript

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