JOHNSON & JOHNSON (JNJ) Company Report

Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of IMAAVY® (nipocalimab-aahu) as the first-ever treatment for warm autoimmune hemolytic anemia (wAIHA).
wAIHA is a rare, life-threatening autoantibody disease affecting approximately 1 in 8,000 people in the U.S., with no FDA-approved therapies currently available.
Data from the pivotal Phase 2/3 ENERGY trial showed rapid and durable hemoglobin responses (hemoglobin ≥10 g/dL and ≥2 g/dL increase for ≥28 days) in significantly more nipocalimab-treated patients vs. placebo, along with sustained fatigue improvement.
IMAAVY® works by selectively blocking the neonatal Fc receptor (FcRn) to reduce circulating IgG autoantibodies while preserving key immune functions.

6 days ago

Press Release

Quantum Surgical acquires NeuWave Medical

JNJ

M&A

Management Change

Quantum Surgical has acquired NeuWave Medical, Inc., with both becoming subsidiaries of the newly formed Precision IO Group Inc.
NeuWave’s microwave ablation devices are used in over 70% of top U.S. cancer centers, complementing Quantum’s Epione® robotic tumor-ablation platform
Medtech veteran Kurt Azarbarzin—formerly CEO of SurgiQuest, EndoQuest Robotics and Verb Surgical—has been appointed CEO of Precision IO Group Inc.
Both companies will continue operating independently to ensure business continuity, supported by investment from Ally Bridge Group

7 days ago

Press Release

Johnson & Johnson presents 3-year TREMFYA® ulcerative colitis remission data

JNJ

J&J reported 3-year data from the QUASAR long-term extension study showing 80.8% clinical remission, 78.6% histo-endoscopic mucosal improvement, and 53.6% endoscopic remission at Week 140.
89% of patients remained on treatment through Week 140, and 87.5% of those in clinical remission at Week 44 maintained remission at Week 140.
Efficacy was sustained regardless of prior biologic or JAK inhibitor therapy, with no new safety concerns observed.

Feb 21, 2026, 1:00 PM

Press Release

Johnson & Johnson reports Phase 1b/2 data for RYBREVANT FASPRO™ in recurrent/metastatic HNSCC

JNJ

In the Phase 1b/2 OrigAMI-4 trial, first-line subcutaneous amivantamab and hyaluronidase-lpuj plus pembrolizumab achieved a 56% overall response rate in recurrent/metastatic, PD-L1–positive, HPV-unrelated head and neck squamous cell carcinoma.
The regimen delivered a 10% complete response rate, with a median progression-free survival of 7.7 months at a median follow-up of 10.4 months and 46% of patients remaining on treatment.
The safety profile was consistent with known effects of the individual agents, with common adverse events including rash (49%), paronychia (46%) and hypoalbuminemia (41%), and led to four treatment discontinuations due to adverse events.
These results support the ongoing Phase 3 OrigAMI-5 study evaluating subcutaneous amivantamab with carboplatin and pembrolizumab as first-line therapy in HPV-unrelated recurrent/metastatic disease.

Feb 19, 2026, 10:00 PM

Press Release

Johnson & Johnson preps potential sale of DePuy Synthes

JNJ

M&A

Johnson & Johnson is assembling documentation to potentially sell its orthopedics unit DePuy Synthes, which generated $9.3 billion in revenue last year and could command a valuation of over $20 billion.
CFO Joe Wolk has indicated a preference for a tax-free spinoff and said the separation process is underway, though an outright sale is not assured.
If spun off, DePuy Synthes would become the largest orthopedic company globally, with a product range including hip, knee, shoulder implants and surgical tools.
Following the reports, J&J’s shares rose about 1%.

Feb 19, 2026, 7:23 PM

Bloomberg

Johnson & Johnson announces $1 billion Pennsylvania cell-therapy plant

JNJ

New Projects/Investments

Hiring

Johnson & Johnson will invest more than $1 billion to build a next-generation cell therapy manufacturing facility on its Janssen campus in Montgomery County, PA, creating roughly 4,000 construction jobs and 500 permanent biomanufacturing roles.
The project is part of J&J’s plan to invest over $55 billion in U.S. manufacturing and R&D through early 2029, driven by recent tariff threats on branded drugs.
The new plant will augment J&J’s 10 existing Pennsylvania sites, which employ about 5,885 people and have an estimated $10 billion annual economic impact in the state.
Analysts note the reshoring trend could become a margin driver but may intensify the biomanufacturing talent crunch even as it strengthens supply-chain resilience.

Feb 18, 2026, 3:26 PM

WSJ

Johnson & Johnson invests in U.S. cell therapy manufacturing facility

JNJ

New Projects/Investments

Johnson & Johnson announced a $1 billion+ investment in a next generation cell therapy manufacturing facility in Montgomery County, Pennsylvania.
The new facility will create over 4,000 construction jobs and 500 biomanufacturing jobs, boosting the state’s economy and strengthening J&J’s $10 billion annual local impact.
This project is part of J&J’s $55 billion U.S. investment in manufacturing, R&D, and technology through early 2029.
J&J’s Pennsylvania footprint now includes ten facilities spanning over 2 million sq ft dedicated to manufacturing, research, distribution, and offices.

Feb 18, 2026, 3:15 PM

Press Release

Johnson & Johnson receives FDA Breakthrough Therapy Designation for RYBREVANT FASPRO™ in head and neck cancer

JNJ

The FDA granted Breakthrough Therapy Designation for subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) as monotherapy in adults with HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy.
The designation is supported by Phase 1b/2 OrigAMI-4 data showing rapid and durable responses in a heavily pretreated patient population.
RYBREVANT FASPRO™, already approved for non-small cell lung cancer, is being evaluated in the Phase 3 OrigAMI-5 trial combining amivantamab with pembrolizumab and carboplatin versus 5-fluorouracil plus pembrolizumab and platinum chemo as first-line treatment in this setting.

Feb 18, 2026, 12:30 PM

Press Release

Johnson & Johnson announces FDA approval of monthly RYBREVANT FASPRO dosing

JNJ

Product Launch

The FDA approved a simplified once-monthly subcutaneous dosing schedule for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in combination with LAZCLUZE® for first-line EGFR-mutated advanced NSCLC, matching the efficacy of the bi-weekly regimen.
Monthly dosing reduces clinic visits, can begin as early as Week 5, and sustains safety with ARR rates of 12% vs 13% for bi-weekly dosing and a fivefold reduction vs historical IV administration (66%).
No new safety signals; 8% of patients discontinued due to treatment-related adverse events, and pharmacokinetic profiles align with established IV and bi-weekly SC data.

Feb 17, 2026, 1:00 PM

Press Release

Johnson & Johnson hit with $250,000 verdict in baby powder-ovarian cancer trial

JNJ

Legal Proceedings

A Philadelphia jury found J&J’s talc-based baby powder directly responsible for the 2019 death of Gayle Emerson, awarding a $250,000 verdict ($50,000 compensatory; $200,000 punitive).
Testimony showed Emerson used the product for over 45 years and was diagnosed with ovarian cancer in 2015 at age 64.
This case is the first of several bellwether trials slated for 2026, amid more than 70,000 consolidated lawsuits in New Jersey federal court, with the MDL’s initial bellwether set for later this year.
J&J ceased North American sales of talc-based powders in 2020 and expanded the global ban in 2023.

Feb 13, 2026, 9:18 PM

Press Release