Johnson & Johnson reports healthcare developments across its Innovative Medicine and MedTech businesses. News commonly covers clinical and scientific data in immunology, oncology, neurology and neuropsychiatry, including medicines and candidates such as CAPLYTA, TREMFYA, JNJ-4804, seltorexant and the INVEGA long-acting injectable schizophrenia portfolio.
Company updates also include medical technology programs such as the investigational OTTAVA robotic surgical system, product and patient-education initiatives, quarterly sales and earnings releases, dividend actions, investor presentations and governance or investor-relations appointments.
Johnson & Johnson (JNJ) reported positive topline results from a pivotal Phase 3 trial of CAPLYTA (lumateperone) 42 mg once daily for acute manic episodes in adults with bipolar I disorder.
The randomized, double-blind Study 451 showed CAPLYTA achieved a statistically significant 4.8-point greater reduction in Young Mania Rating Scale (YMRS) total score versus placebo at Week 3 (effect size −0.69; p<.0001), with significant improvement observed as early as Day 3 and sustained through Week 3. Patients on CAPLYTA also had greater improvement in overall illness severity on the Clinical Global Impression–Severity scale (least-squares mean difference −0.5; p<.0001) and roughly double the clinical response rate, defined as ≥50% YMRS reduction, compared with placebo (45.8% vs. 20.9%; p<.0001). CAPLYTA’s safety and tolerability were consistent with its established profile, with low discontinuation rates; common treatment-related adverse events ≥5% and at least twice placebo were dry mouth and nausea (each 7.9% vs. 3.4% and 2.3%, respectively). CAPLYTA is not approved for treating manic episodes in bipolar I disorder, and a second Phase 3 mania study has completed enrollment with data analysis ongoing.
Johnson & Johnson (JNJ) reported new Phase 2b COPERNICUS data on subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib) with prophylactic strategies in previously untreated EGFR-mutated advanced non-small cell lung cancer.
In 214 U.S. patients, treated with once-every-four-weeks dosing and prophylaxis for venous thromboembolism (VTE) and skin toxicity, most adverse events were Grade 1–2 at a median 8.3‑month follow-up, with no new safety signals. Rash occurred in 25% of patients, administration-related reactions and VTE each in 3%, and 8% discontinued due to adverse events; fewer than 1% discontinued for rash or VTE, and none for administration-related reactions. These rates were numerically lower than with intravenous RYBREVANT plus LAZCLUZE in the MARIPOSA Phase 3 study, where rash, administration-related reactions and VTE in the first four months were 55%, 55% and 23%, respectively. MARIPOSA previously showed a statistically significant overall survival benefit versus osimertinib (HR 0.75; P=0.005).
Johnson & Johnson (JNJ) reported final overall survival results from the Phase 3 PAPILLON study of first-line IV RYBREVANT (amivantamab-vmjw) plus carboplatin-pemetrexed versus chemotherapy alone in advanced NSCLC with EGFR exon 20 insertion mutations.
The combination achieved a median overall survival of 34.3 months versus 27.9 months with chemotherapy alone, despite 76 percent of eligible chemotherapy patients crossing over to second-line RYBREVANT. This is described as the longest reported median OS in this population and nearly double historical medians. A prespecified crossover-adjusted analysis showed a 43 percent reduction in risk of death (HR 0.57; 95% CI 0.39–0.82; nominal P=0.003). Progression-free survival through second progression (PFS2) was 28.3 versus 17.5 months (HR 0.59; nominal P<0.0001). Twelve percent of patients remained on first-line therapy at cutoff, and patient-reported outcomes favored the combination. Safety was consistent with prior experience, with no new signals and common treatment-related events including paronychia (60%), neutropenia (60%) and rash (58%).
Johnson & Johnson (JNJ) received CE Marking for ACUVUE OASYS MAX 2-Week, a new reusable contact lens using MAX technologies designed to provide comfort and visual clarity through the full 14-day wear cycle. The lens combines Eye-Inspired Designs with an OptiBlue Light Filter that filters at least 60% of blue-violet light, TearStable Technology to lock in moisture, and Class 1 UV blocking in each lens.
The product will launch via a phased rollout starting in select European markets in late 2026, with broader expansion planned across 2027 and 2028, subject to local regulatory approvals and market readiness. ACUVUE OASYS MAX 2-Week is not approved by the U.S. FDA and is not available for sale in the United States.
Johnson & Johnson (JNJ) will present 24 abstracts with new clinical and real‑world neuropsychiatry data at the 2026 Psych Congress Annual Meeting in New Orleans from September 15‑19.
Highlights include first presentation of pivotal Phase 3 data for CAPLYTA (lumateperone) in adults with bipolar I mania, plus additional CAPLYTA data in bipolar depression and major depressive disorder. Further presentations cover SPRAVATO (esketamine) analyses focused on anhedonia, schizophrenia long‑acting injectable real‑world outcomes, and Phase 3 and real‑world data for investigational agent seltorexant in MDD with insomnia symptoms. Johnson & Johnson states these efforts reflect a focus on complex, high‑burden mood and psychotic disorders.
Johnson & Johnson (JNJ) will present at the Deutsche Bank 2026 Healthcare Summit on Thursday, September 17, 2026. Company management will join a Fireside Chat at 12:00 p.m. Eastern Time. A live audio webcast and later archived replay will be available via the Johnson & Johnson Investor Relations website.
Johnson & Johnson (NYSE: JNJ) will host an investor conference call at 8:30 a.m. ET on Tuesday, October 13 to review third-quarter results. CEO Joaquin Duato, CFO Joseph J. Wolk and VP Investor Relations Ryan Koors will lead the call, with other executives joining the Q&A portion. The webcast, presentation materials and the related press release (available around 6:45 a.m. ET that morning) can be accessed via www.investor.jnj.com.
Johnson & Johnson (NYSE: JNJ) announced that the U.S. FDA has approved IMAAVY (nipocalimab-aahu) as the first treatment specifically for warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients ≥12 years currently or previously treated with corticosteroids, following Priority Review.
The approval is based on the Phase 2/3 randomized, placebo-controlled ENERGY trial, where approximately three times as many patients on the approved 30 mg/kg IV every 4 weeks dose achieved durable hemoglobin response versus placebo by Week 24. IMAAVY-treated patients showed a mean hemoglobin increase of 1 g/dL at Week 1 and a 3.5‑point higher mean FACIT‑Fatigue score at Week 24 versus placebo. The safety profile was consistent with prior experience in generalized myasthenia gravis; common adverse reactions in wAIHA included peripheral edema, diarrhea, and fever.
Johnson & Johnson (NYSE: JNJ) will participate in the Morgan Stanley 24th Annual Global Healthcare Conference on Monday, September 14, 2026. Company management is scheduled for a Fireside Chat at 11:30 a.m. Eastern Time, accessible via live audio webcast on Johnson & Johnson's investor relations website, with a replay available afterward.
Johnson & Johnson (NYSE: JNJ) will present at the 2026 Wells Fargo Healthcare Conference on Wednesday, September 9, 2026. Company management will join a Fireside Chat at 11:00 a.m. Eastern Time, with a live audio webcast and archived replay accessible via Johnson & Johnson’s investor relations website.