RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Breakthrough Therapy (China), Orphan Drug (South Korea)

Structure/Sequence

Sequence Code 143885L

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Sequence Code 13387733H

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Sequence Code 13387743H

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Sequence Code 13387747L

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Clinical Trials associated with Amivantamab-VMJM

NCT07808359

/ Not yet recruitingPhase 2IIT

Amivantamab in Patients With Metastatic/Recurrent Penile Squamous Cell Carcinoma Who Progressed to First-line Platinum-Based Chemotherapy: APOLO TRIAL (LACOG 2425)

This is a collaborative, multicenter, open-label, Phase 2 clinical trial (APOLO TRIAL / LACOG 2425) designed to evaluate the efficacy, safety, and tolerability of subcutaneous amivantamab monotherapy in adult patients with histologically confirmed recurrent or metastatic penile squamous cell carcinoma (PSCC). Eligible participants must have experienced disease progression on or after receiving at least one platinum-based chemotherapy regimen (with or without immunotherapy). The study allocates participants into two parallel non-randomized cohorts based on their human papillomavirus (HPV) status (HPV-positive and HPV-negative).

Start Date01 Nov 2026

Sponsor / Collaborator-

CTRI/2026/09/118067

/ Not yet recruitingPhase 4

A Phase 4, Open-Label Study to Evaluate Safety of Amivantamab inCombination With Chemotherapy in Indian Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 19del or Exon21 L858R Mutations After Progression on Osimertinib - NA

Start Date22 Oct 2026

Sponsor / Collaborator-

CTIS2026-525268-16-00

/ Not yet recruitingPhase 2/3IIT

DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:” “A multi-arms prospective, randomized phase II study to evaluate the best sequential therapeutic strategis in patients with metastatic non-small cell lung cancer harboring targetable genomic driver alterations”

Start Date30 Sep 2026

Sponsor / Collaborator-

100 Clinical Results associated with Amivantamab-VMJM

100 Translational Medicine associated with Amivantamab-VMJM

100 Patents (Medical) associated with Amivantamab-VMJM

339

Literatures (Medical) associated with Amivantamab-VMJM

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer

Article

Author: Upton, Elysia ; Hearmon, Natalie ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Lopes, Gilberto de Lima ; Karia, Pritesh

OBJECTIVES:

Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.

METHODS:

A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.

RESULTS:

The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.

LIMITATIONS:

Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.

CONCLUSIONS:

From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.

01 Nov 2026·LASERS IN SURGERY AND MEDICINE

532‐nm KTP Laser Treatment of Epidermal Growth Factor Receptor Inhibitor–Associated Paronychia: A Case Report

Article

Author: Dreifus, Emilee M. ; Chokshi, Aditi ; Eber, Ariel E.

ABSTRACT:

Objectives:

Paronychia is a common and often painful cutaneous adverse event of epidermal growth factor receptor inhibitor therapy that can impair function and quality of life. We report the first known case of amivantamab‐associated paronychia successfully treated with 532‐nm potassium‐titanyl‐phosphate laser.

Materials and Methods:

A 67‐year‐old man with metastatic non‐small cell lung cancer receiving amivantamab developed painful periungual inflammation with pyogenic granuloma‐like changes involving multiple fingers and both great toes after failing multiple topical therapies. A representative lesion on the left fourth digit was selected for treatment and underwent two sessions of 532‐nm KTP laser therapy. Treated and untreated digits were compared for clinical response.

Results:

Following two treatment sessions, the treated digit demonstrated marked improvement in erythema, pain, and friability. Untreated digits remained inflamed and symptomatic, serving as a within‐patient comparator. No adverse events were observed.

Conclusion:

Given its superficial vascular targeting mechanism and broad clinical availability, the 532‐nm KTP laser may represent a practical and effective therapeutic option for refractory EGFRI‐associated paronychia. To our knowledge, this is the first reported case of successful treatment of amivantamab‐associated paronychia with a 532‐nm KTP laser.

01 Nov 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Biomarker-guided treatment selection in metastatic colorectal cancer: A critical review of established and emerging therapies

Review

Author: Alkhazna, Shahd ; Tojjari, Alireza ; Pourbahrighesmat, Shamimeh ; Saeed, Anwaar

Metastatic colorectal cancer (mCRC) is increasingly managed according to mismatch repair status and actionable molecular alterations. In this structured narrative review, we separately examine mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) and microsatellite-stable/mismatch repair-proficient (MSS/pMMR) disease and distinguish established treatments from investigational strategies. In dMMR/MSI-H mCRC, immune checkpoint inhibition is the established first-line standard, with pembrolizumab and nivolumab plus ipilimumab producing durable disease control. In MSS/pMMR mCRC, tumor molecular findings guide targeted therapy. For BRAF V600E-mutant disease, encorafenib plus cetuximab with fluoropyrimidine-based chemotherapy is a first-line standard. HER2-directed therapy with tucatinib plus trastuzumab or trastuzumab deruxtecan and combined KRAS G12C and EGFR inhibition are established after prior treatment but are not approved in the first-line setting. Across MMR subgroups, rare NTRK or RET fusions can confer eligibility for tumor-agnostic TRK or RET inhibition, although CRC-specific cohorts remain small. In previously treated non-MSI-H/dMMR mCRC, STELLAR-303 was the first phase 3 trial to demonstrate a significant overall survival benefit with an immune checkpoint inhibitor-containing regimen, zanzalintinib plus atezolizumab. Other investigational strategies include additional immunotherapy combinations, EGFR-MET bispecific antibody therapy with amivantamab, T-cell-engaging bispecific antibodies, therapeutic cancer vaccines, cellular therapies, and microbiome-directed approaches. For each therapeutic class, we summarize the supporting evidence, define its place in the treatment sequence, and identify the remaining evidence gaps.

404

News (Medical) associated with Amivantamab-VMJM

20 Oct 2026

·ir.actiniumpharma.com

Actinium Pharmaceuticals Presents EANM 2026 Results Reinforcing ATNM-400's Pan-Tumor Potential Across Lung, Colorectal and Ovarian Cancer Models

ATNM-400 demonstrated activity across EGFR-, KRAS- and ALK-driven lung cancer models, supporting mutation-agnostic development as monotherapy and in combination with established treatments In colorectal cancer, adding ATNM-400 to standard therapy increased tumor growth inhibition to 72% from 25% for oxaliplatin and bevacizumab in a poorly responsive model with moderate target expression In ovarian cancer, ATNM-400 achieved 93% tumor growth inhibition as monotherapy and retained activity following bevacizumab failure Three presentations expand the preclinical foundation for ATNM-400 as a potential pan-tumor treatment, complementing ongoing clinical development in prostate cancer NEW YORK, Oct. 20, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in differentiated targeted radiotherapies with the potential to transform cancer treatment, today announced new preclinical results demonstrating the broad antitumor potential of ATNM-400 across non-small cell lung cancer (NSCLC), colorectal cancer and ovarian cancer models. The findings were presented in an oral presentation and two e-posters at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM), October 17–21, 2026, in Vienna, Austria. ATNM-400 is the Company's first-in-class Actinium-225 (²²⁵Ac) antibody radioconjugate targeting HER3, a tumor-associated antigen implicated in cancer-cell survival and treatment resistance. By delivering high-energy alpha-particle radiation to HER3-expressing tumor cells, ATNM-400 is designed to induce DNA double-strand breaks through a mechanism distinct from conventional pathway inhibition. The EANM results demonstrate activity across molecularly diverse tumors and treatment-resistant disease, supporting development as both a standalone therapy and a combination partner for established treatments. The studies broaden ATNM-400's preclinical evidence beyond previously reported prostate and breast cancer findings and extend its lung cancer program across multiple oncogenic drivers. Together with the Company's ongoing clinical development in metastatic castration-resistant prostate cancer (mCRPC), these results support a strategy to advance ATNM-400 across multiple large solid tumor indications. Sandesh Seth, Actinium's Chairman and CEO, said, "These results strengthen our conviction in ATNM-400's pan-tumor potential and our opportunity to expand targeted radiotherapy across major solid tumor indications. In lung cancer, activity across EGFR-, KRAS- and ALK-driven models supports an approach that could reach patients beyond a single mutation-defined population. In colorectal cancer, ATNM-400 substantially improved tumor control when added to a standard regimen with limited activity, while in ovarian cancer it demonstrated strong single-agent activity, including after bevacizumab failure. This breadth of activity supports our vision for ATNM-400 as a potential treatment backbone, both on its own and alongside established therapies, for patients whose cancers are inadequately served by current options." Adeela Kamal, Ph.D., Actinium's Chief Scientific Officer, added, "HER3 provides a compelling biological link across these cancers through its role in tumor-cell survival and treatment resistance. ATNM-400 uses this target to deliver the potent DNA-damaging effects of Actinium-225, with activity that is not dependent on inhibiting a specific oncogenic driver. The activity across distinct lung cancer subtypes, improved responses to standard therapy in colorectal cancer, and retained activity after bevacizumab failure in ovarian cancer strengthen the scientific rationale for this approach. These findings support further development of ATNM-400 across HER3-expressing solid tumors, with combinations selected to build on its single-agent activity." Highlights from the EANM 2026 Presentations Non-Small Cell Lung Cancer | Oral Presentation EPS-149 ATNM-400 demonstrated antitumor activity across EGFR-mutant, KRAS G12C-mutant and ALK-rearranged NSCLC models, supporting a HER3-directed approach with potential beyond any single oncogenic driver. In the KRAS G12C-mutant NCI-H358 model, ATNM-400 monotherapy achieved 81% tumor growth inhibition (TGI), compared with 38% for adagrasib and 29% for the HER3-directed antibody-drug conjugate patritumab deruxtecan. Combining ATNM-400 with adagrasib increased TGI to 105%, consistent with tumor regression. These findings support both single-agent activity and the potential to deepen responses to KRAS-targeted therapy. In the ALK-rearranged NCI-H3122 model, ATNM-400 plus crizotinib achieved 97% TGI, compared with 50% for ATNM-400, 55% for crizotinib and 26% for patritumab deruxtecan alone. ATNM-400-containing regimens were well tolerated and extended survival relative to controls and the HER3-directed antibody-drug conjugate. In the EGFR-mutant NCI-H1975 model, ATNM-400 plus pemetrexed and cisplatin achieved 86% TGI, compared with 52% for amivantamab plus chemotherapy and 48% for amivantamab plus lazertinib. ATNM-400 monotherapy achieved 63% TGI. The ATNM-400 and chemotherapy combination also prolonged survival during the study period. Colorectal Cancer | e-Poster EP-0163 ATNM-400 demonstrated combination activity in colorectal cancer models spanning moderate-to-high HER3 expression, including tumors with limited sensitivity to standard therapy. In the HCT15 model with moderate HER3 expression, ATNM-400 plus oxaliplatin and bevacizumab achieved 72% TGI, compared with 25% for oxaliplatin and bevacizumab and 27% for ATNM-400 alone at the corresponding dose. The combination extended survival, supporting its potential to improve tumor control where standard therapy has limited activity. In the SW620 model with high HER3 expression, ATNM-400 plus bevacizumab achieved 88% TGI, comparable to 85% for oxaliplatin plus bevacizumab, while ATNM-400 monotherapy achieved 57% TGI. Survival with ATNM-400 plus bevacizumab was also comparable to the chemotherapy-containing regimen, supporting further evaluation of a combination that omits oxaliplatin. Ovarian Cancer | e-Poster EP-0176 ATNM-400 demonstrated strong single-agent activity in ovarian cancer, including after bevacizumab failure, with additional survival findings in an immunocompetent model of disseminated disease. In the OVCAR-5 model, ATNM-400 monotherapy achieved 93% TGI, compared with 54% for bevacizumab. The combination achieved 85% TGI without additional benefit over ATNM-400 alone, highlighting the strength of its standalone activity in this model. ATNM-400-containing regimens were favorably tolerated and prolonged survival relative to control groups. Following bevacizumab failure, ATNM-400 monotherapy retained activity, achieving 50% TGI with prolonged survival and favorable tolerability. These findings support development in treatment-resistant ovarian cancer. In the disseminated ID8-fLuc ovarian cancer model in immunocompetent mice, ATNM-400-containing regimens prolonged survival relative to their respective controls. Combinations with carboplatin and paclitaxel also prolonged survival compared with chemotherapy alone. Survival follow-up remained ongoing at the time of the presentation, with some animals in ATNM-400 treatment groups still alive. Preclinical Tolerability and Translational Development The studies generally showed favorable tolerability at the evaluated doses. In ovarian cancer studies, single-bolus and fractionated dosing produced minimal changes in assessed blood, liver and kidney markers. No treatment-related abnormalities were observed in the assessed markers in the HCT15 colorectal model; a slight ALT elevation was observed with ATNM-400 plus bevacizumab in the SW620 model. These findings support continued translational evaluation of ATNM-400 as monotherapy and in selected combinations. About ATNM‑400 and HER3 ATNM‑400 is an investigational antibody radioconjugate that pairs the HER3‑targeting monoclonal antibody barecetamab with the alpha‑emitting isotope Actinium‑225. Its antibody‑based design combines antigen‑specific targeting with the potential for sustained tumor localization, supporting prolonged delivery of high‑energy alpha radiation. Tumor uptake and retention observed through Day 7 with the ⁸⁹Zr‑labeled imaging counterpart support this development rationale alongside the approximately 10‑day half‑life of ²²⁵Ac. The theranostic approach enables noninvasive visualization of antibody distribution to inform therapeutic development. ATNM‑400 is differentiated from PSMA‑targeted radiotherapies by its focus on HER3, an antigen implicated in tumor survival and treatment resistance. PSMA‑directed approaches include Novartis' Pluvicto and a broad pipeline of investigational therapies, including Telix Pharmaceuticals' TLX591‑Tx, Clarity Pharmaceuticals' ⁶⁷Cu‑SAR‑bisPSMA, Convergent Therapeutics' CONV01‑α, AstraZeneca's AZD2265 (formerly FPI‑2265), Curium's lutetium‑177 zadavotide guraxetan (¹⁷⁷Lu‑PSMA‑I&T), ARTBIO's AB001 and AdvanCell's ADVC001. These programs span small‑molecule and antibody‑based therapies using beta‑ or alpha‑emitting isotopes. ATNM‑400 combines HER3 targeting with an Actinium‑225 antibody radioconjugate, offering a distinct biological approach with the potential to expand radiotherapy across the broad mCRPC population, including patients with PSMA‑low or PSMA‑negative disease and those who do not respond to or progress following PSMA‑directed treatment. Its HER3‑directed mechanism also supports investigation beyond prostate cancer in other HER3‑expressing solid tumors. HER3, also known as ERBB3, is a member of the epidermal growth factor receptor family involved in signaling pathways that support tumor growth, survival and resistance to treatment. HER3‑directed antibody‑drug conjugates in clinical development include BioNTech and MediLink's BNT326/YL202, Bristol Myers Squibb and SystImmune's EGFR × HER3 bispecific ADC izalontamab brengitecan (iza‑bren), and Daiichi Sankyo and Merck's patritumab deruxtecan (HER3‑DXd). These programs underscore the clinical development interest in HER3 as an oncology target. ATNM‑400 applies a distinct payload strategy, using alpha radiation in place of a conventional cytotoxic drug. Its preclinical activity in prostate, non‑small cell lung and breast cancer models supports investigation as a potential pan‑cancer radiotherapy, as a monotherapy and in rational combinations. About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology‑driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM‑400 and Actimab‑A with pan‑tumor potential; (2) Actimab‑A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab‑B for bone marrow transplant and Iomab‑ACT for cell and gene therapy conditioning. ATNM‑400 targets HER3, an antigen distinct from PSMA, and is in a first‑in‑human Phase 1 study in mCRPC, with preclinical activity across metastatic castration‑resistant prostate cancer (mCRPC), non‑small cell lung cancer (NSCLC), and breast cancer. Actimab‑A has shown improved survival in relapsed/refractory AML with CLAG‑M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron‑based production of Ac‑225. For more information, please visit www.actiniumpharma.com. Forward‑Looking Statements This press release may contain projections or other "forward‑looking statements" within the meaning of the "safe‑harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10‑K, subsequent quarterly reports on Forms 10‑Q and Forms 8‑K, each as amended and supplemented from time to time. Investors: investorrelations@actiniumpharma.com View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-presents-eanm-2026-results-reinforcing-atnm-400s-pan-tumor-potential-across-lung-colorectal-and-ovarian-cancer-models-302913279.html SOURCE Actinium Pharmaceuticals, Inc. Released October 20, 2026

Clinical ResultRadiation TherapyPhase 1

13 Oct 2026

·www.fiercepharma.com

J&J’s new pharma chief expects Icotyde’s psoriasis launch momentum to repeat across indications

As Johnson & Johnson rode out 2026’s third quarter, leveraging its pharmaceutical segment to navigate medtech headwinds, much of the company’s near-term excitement has turned to IL-23 pill Icotyde, which has been hailed as a potential game changer in plaque psoriasis. J&J has yet to report out discrete sales for Icotyde, or icotrokinra, though the company on Tuesday cited the medicine’s uptake in the U.S. as one driving factor in the 1.3% year-over-year increase in immunology revenue it posted for Q3, during which the unit collectively brought home (PDF) more than $4.2 billion. “We do foresee Icotyde to be one of our biggest assets in innovative medicine, and it’s off to an incredibly great start,” Tom Cavanaugh, worldwide chairman of innovative medicine at J&J, said of the performance on the company’s earnings call Tuesday. Since the drug’s approval and launch earlier this year, J&J has recorded more than 20,000 patient starts on Icotyde, funneled through a pool of nearly 9,000 prescribers, Cavanaugh said, noting that the performance is “absolutely tracking better than most all launches in psoriatic disease.” The green light specifically covers the use of Icotyde to treat moderate-to-severe plaque psoriasis in patients ages 12 years and older who are candidates for systemic therapy or phototherapy. At the time of approval, J&J’s then-innovative medicines chief, Jennifer Taubert, opined that Icotyde could set a “new standard” for treatment of the moderate-to-severe form of plaque psoriasis, which is estimated to affect some 8 million people in the U.S. Taubert announced her retirement earlier this year and was formally replaced by Cavanaugh at the innovative medicines helm on Sept. 1. Once-a-day oral Icotyde also boasts a potentially meaningful convenience edge over most other systemic psoriasis treatments, like AbbVie’s Skyrizi or J&J’s sister medicine Tremfya, which often come as injections. Further breaking down the Icotyde launch mix on Tuesday’s call, Cavanaugh explained that around 60% of those new patients are brand-new to a systemic plaque psoriasis treatment, with the remaining 40% comprising a relatively even split between people switching from orals and those coming over from other treatments, which mainly consists of biologics. As the launch continues to play out in psoriasis, Cavanaugh reiterated that many more opportunities lie ahead for Icotyde, which J&J plans to bolster with two upcoming phase 3 readouts in psoriatic arthritis and in a head-to-head against its own Stelara, plus potential expansions further down the line in indications like inflammatory bowel disease. The J&J exec stressed that the company is “expecting similar results with regards to launch performance as we go into those other indications.” Though investors and industry watchers will have to wait a while longer for Icotyde sales to report out, “I’m confident we’re going to be doing that next year, just based on the momentum and the progress that we’re seeing with the launch,” Cavanaugh added later during the call. All told, J&J lifted sales by 5.9% in the third quarter to reach total revenues of $25.4 billion, which analysts at Leerink Partners noted fell in line with consensus. Overall, innovative medicines contributed around $16.8 billion to the haul, up from around $15.6 billion for the period in 2025, while the company’s medtech segment grew 2.5% year over year to a little more than $8.6 billion. Immunology remained the major growth driver overall for the period, primarily thanks to psoriatic and IBD medicine Tremfya, which reported sales of $2.4 billion in Q3, above the estimate put forward by analysts at TD Cowen. Other key J&J products that exceeded TD Cowen’s expectations for the period included Stelara, Carvykti and Caplyta, to name a few, while medications like Rybrevant, Spravato and Darzalex missed the analyst shop’s targets. Meanwhile, buoyed by its recent quarterly performance, J&J raised the lower end of its full-year sales guidance. The company now expects revenue to fall between $101 billion and $101.4 billion, versus its previous forecast of $100.8 billion to $101.4 billion.

Phase 3BiosimilarDrug ApprovalExecutive Change

13 Oct 2026

·www.mddionline.com

J&J Inches Closer to $100 Billion… Will a Medtech Stumble Cloud the Story?

Johnson & Johnson delivered a third-quarter performance on October 13, 2026, that told two very different stories depending on which part of the business you were watching. The pharmaceutical arm, now branded Innovative Medicine, continued its hot streak, while the medical device business once again fell short of where the company wanted it to be. Investors clearly noticed the split. Despite revenue coming in ahead of expectations, J&J shares slipped as much as 4.36% following the announcement, suggesting Wall Street cared more about where the cracks are than where the growth is. The headline numbers were respectable on their face. The company posted $25.4 billion in quarterly revenue, edging past analyst expectations of roughly $25.28 billion, while adjusted earnings of $2.59 per share also topped the consensus estimate of around $2.54. J&J used the results as an opportunity to raise its full-year guidance once again, nudging its reported sales outlook up to a range of $101 billion to $101.4 billion and lifting its adjusted earnings forecast to a midpoint of $11.10 per share. That revenue trajectory would mark a milestone the company has never hit in its 140-year history: crossing the $100 billion mark in annual sales. Still, the quarter wasn't without pain. Reported net earnings cratered to just $210 million, or nine cents per diluted share, a steep drop from the $5.15 billion the company posted in the same period a year earlier. That decline wasn't a sign of operational trouble, but rather the result of roughly $7 billion in special charges tied to talc litigation and recent acquisitions, including Firefly Bio and Sail Biomedicines. Strip those one-time items away, and the underlying business looked considerably healthier, with adjusted net earnings landing at $6.3 billion. The real engine behind J&J's growth story continues to be its drug business. Innovative Medicine sales jumped nearly 8% to $16.76 billion, powered by a handful of standout products. Tremfya, the company's immune disease treatment, was the breakout star of the quarter, with sales soaring 68% to $2.4 billion and comfortably beating analyst projections of about $2.19 billion. That growth matters even more given the backdrop. Stelara, once a reliable blockbuster, has been losing ground to generic competition, with sales falling 54% to $716 million. Tremfya has effectively stepped in to fill that gap, aided by recent approvals in inflammatory bowel disease treatment. Elsewhere in the pharmaceutical portfolio, cancer treatment Darzalex grew about 16% to $4.24 billion, and oncology as a whole led the division with 16.7% operational growth, lifted by newer therapies like Carvykti, Tecvayli, and the recently launched Rybrevant and Lazcluze combination. Medtech told a far less flattering story. Sales rose just 2.5% to $8.6 billion, missing analyst estimates and drawing a notably blunt assessment from Chief Financial Officer Joe Wolk. "Medtech needs to improve quite frankly," Wolk told Bloomberg , acknowledging that the segment underperformed internal expectations. He pointed to a mix of external pressures weighing on the business, including geopolitical tension in the Middle East, budget tightening among European governments, and ongoing pricing pressure in China. In an interview with Reuters , Wolk elaborated on the Middle East dynamic specifically, noting that countries like Kuwait, the UAE, and Saudi Arabia still want premium healthcare systems, "but their budgets now are being resourced and allocated towards defense." Within medtech, cardiovascular products were the bright spot, growing 4.1% on the strength of new electrophysiology platforms, while surgery sales actually declined slightly, hurt by procurement changes in China and the same regional disruptions in the Middle East. One genuine bright spot inside medtech came from the FDA's decision to authorize the company's Ottava robotic surgical system , which J&J is positioning as a legitimate new category in surgical robotics rather than just another entrant into an increasingly crowded field. The system is built around four robotic arms integrated directly into a standard surgical table rather than mounted on separate carts or booms, a design the company says takes up 30% to 50% less operating room space than competing systems. Its initial clearance covers ten general surgery procedures, including gastric bypass and hernia repair, and the company says it has already signed its first commercial customer. Perhaps the biggest strategic headline of the quarter had nothing to do with the current numbers at all. J&J confirmed it intends to spin off its orthopedics business, DePuy Synthes , into a standalone company, with CFO Wolk telling CNBC the company is now targeting mid-2027 for the separation. He made clear the company isn't rushing into a sale just because one is on the table. "We're not cash strapped. We don't have to pursue a deal that maybe is not optimal," Wolk said, adding that J&J has the flexibility to "sit this out for a little bit" before executing the separation on its own timeline. That comment comes against the backdrop of reports that Apollo Global Management has been in talks to acquire the orthopedics unit in a deal that could value it near $20 billion, though Wolk's remarks to Bloomberg suggested the company is leaning toward a straightforward spinoff rather than an outright sale, calling it "the greatest way to create value." Looking at the bigger picture, CEO Joaquin Duato framed the quarter as confirmation that the company's long-term strategy is working, pointing to the Ottava authorization alongside "positive Phase 3 results in multiple myeloma" as proof points. In a separate statement, he said the quarter's performance gives the company "clearer line of sight to double-digit growth by the end of the decade," a target executives say is being driven by internal pipeline execution rather than any assumed wave of acquisitions, even as the company says it remains open to opportunities if they arise. For now, J&J finished the quarter with $17 billion in cash and marketable securities against $45 billion in debt, generated roughly $15 billion in free cash flow over the first nine months of the year, and returned $3.2 billion to shareholders through dividends, continuing a streak that now stretches 55 consecutive years of annual increases. Investors, however, appeared less interested in that stability than in the open questions still hanging over the company. Management has promised more detail on both 2027 guidance and the orthopedics separation at an investor event scheduled for December 8, 2026, leaving the market to wait for clarity on whether medtech can turn itself around and whether the DePuy Synthes exit will unfold on the company's preferred terms.

AcquisitionPhase 3

100 Deals associated with Amivantamab-VMJM

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amivantamab-VMJM	L01	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
EGFR positive non-small cell lung cancer	Japan	Janssen Pharmaceutical KK	27 Mar 2025
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	United States	Janssen Biotech, Inc.	19 Aug 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	United States	Janssen Biotech, Inc.	19 Aug 2024
Non-Small Cell Lung Cancer	Canada	Janssen, Inc.	30 Mar 2022
EGFR ex20ins mutation in non-small cell lung cancer	United States	Janssen Biotech, Inc.	21 May 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Janssen-Cilag International NV	26 Jan 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Shanghai Johnson & Johnson Pharmaceutical Ltd.	26 Jan 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Cilag AG	26 Jan 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	United States	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	China	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Japan	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Australia	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Austria	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Belgium	Janssen Research & Development LLC	03 Dec 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Brazil	Janssen Research & Development LLC	03 Dec 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06120140 (COCOON, ESMO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutant	70	SC amivantamab + lazertinib with optimized COCOON DM	arqerkrnzu(pwxsmoyttz) = lrkkpofqrd pjocvokhzj (urtthobbpc ) View more	Positive	23 Oct 2026
NCT04487080 (MARIPOSA, ESMO2026)	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutated	429	Amivantamab-lazertinib	nzcjsotrrv(brrlyjwqhx) = aqapzejfsr qofxzaxoxp (qidgnjutbf ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	EGFR Mutation Lung Cancer	900	Amivantamab	mijemeoywv(clcrpsiscs) = Hematologic and vascular events included anemia (31.1%, 99/318), lymphopenia (16.7%, 70/420), and venous thromboembolism (11.3%, 89/790). tldjbaacha (kebhklfbgf ) View more	Positive	23 Oct 2026
NCT03767075 (Basket of Baskets, ESMO2026)	Phase 2	Solid tumor MET kinase domain mutations/fusion-genes \| MET-amplifications \| EGFR mutations	51	Amivantamab (MET kinase domain mutations/fusion-genes)	pcfscwnjah(sxgbvseoel) = hzgxrjuhol tvwpvwfhmv (tklmuvpxuj ) View more	Positive	23 Oct 2026
				Amivantamab (MET-amplifications CNG ≥6)	pcfscwnjah(sxgbvseoel) = jyhggzzmzm tvwpvwfhmv (tklmuvpxuj ) View more
NCT06385080 (OrigAMI-4, ESMO2026)	Phase 1/2	Squamous cell carcinoma of head and neck metastatic First line	29	Amivantamab + pembrolizumab + carboplatin (HPV-unrelated disease)	rgozvxlgpv(gxrjrxyijy) = ijxbehqxzf mendfoqpyp (ddcphmmrct, 55 - 92)	Positive	23 Oct 2026
				Amivantamab + pembrolizumab + carboplatin (HPV+ oropharyngeal squamous cell carcinoma (OPSCC))	rgozvxlgpv(gxrjrxyijy) = ojhiawtbiv mendfoqpyp (ddcphmmrct )
NCT05601973 (AMAZE-lung, Pubmed \| Lancet Respir Med)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR-mutant	61	LazertinibAmivantamab + LazertinibAmivantamab + LazertinibAmivantamab	bforgfjoru(icpmyoohuc) = dureiwrixa vlzikossgd (osmbqdbnjr, 21 - 47) View more	Positive	01 Oct 2026
NCT05299125 (AMIGO-1, WCLC2026)	Phase 2	Non-Small Cell Lung Cancer First line EGFR-mutant	54	Amivantamab+Lazertinib+Pemetrexed	mdxsmopgbj(yslwpwmxmr) = kakawjtvol qlilvgbygj (mubvxarebv, 57.5 - 74.4) View more	Positive	12 Sep 2026
NCT04538664 (PAPILLON, WCLC2026)	Phase 3	Non-Small Cell Lung Cancer First line EGFR Ex20ins	308	Amivantamab-chemotherapy	dnypzvapld(kedhcdcwsb) = csfelnzhue xnyjqrgqll (kqbbcjbutc, 27.0 - 40.8) View more	Positive	12 Sep 2026
				Chemotherapy	dnypzvapld(kedhcdcwsb) = klxhykufpu xnyjqrgqll (kqbbcjbutc, 24.0 - 32.4) View more
WCLC2026	Not Applicable	Non-Small Cell Lung Cancer	50	Amivantamab+Osimertinib	vnyhsaxmdx(lhrfnrgwov) = Grade 5 ILD was observed in 3 patients (6%), two of whom had prior exposure to immune checkpoint inhibitors (ICIs), including one within 3 months of ICI use bfyhxvjdrl (ljddnentfk ) View more	Positive	12 Sep 2026
				Amivantamab+Osimertinib (2nd or 3rd line)
WCLC2026	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	18	Amivantamab + Osimertinib	rcnsogikqd(ryddoeaehy) = pdntqsaifb eoqlqmgquw (tscgtsuquj, 9.7 - 53.5) View more	Positive	12 Sep 2026
				Amivantamab + Osimertinib (exon 21 L858R)	rcnsogikqd(ryddoeaehy) = yeknxvzaxj eoqlqmgquw (tscgtsuquj ) View more

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