J&J's Tremfya Meets Endpoints in Phase 4 STAR Psoriatic Arthritis Study

โดย Insider Monkey·US·Read original
Summary · why it matters

Johnson & Johnson announced top-line findings from its Phase 4 STAR study evaluating Tremfya in biologic-naive adults with active psoriatic arthritis and axial involvement, with the drug meeting primary and secondary endpoints. The study is the first randomized, placebo-controlled trial to prospectively evaluate an IL-23 inhibitor using objective MRI assessments, showing improvements in axial symptoms alongside MRI-confirmed reductions in joint inflammation. The result supports J&J's strategy of expanding its immunology growth drivers as legacy products face pressure; in Q2 2026 the company reported operational sales growth of 5.6% to $25.3 billion, led by 6.8% operational growth in Innovative Medicine, and raised full-year 2026 sales guidance to $101.1 billion at the midpoint, or 7.3% growth, with adjusted operational EPS guidance of $11.58. J&J still faces an approximately 760-basis-point operational growth drag from declining Stelara sales due to biosimilar entry, and MedTech growth moderated to 3.6% operational growth in the quarter. Tremfya's expanded addressable population must scale rapidly to replace Stelara's multi-billion-dollar cash flow stream, while litigation reserves and restructuring charges remain near-term headwinds.

Impact on assets 3

Biotech & Genomic Medicine▲ · 3 stocks
Johnson & Johnson
JNJ
▲ PositiveTechnologyrelevance

Tremfya met primary and secondary endpoints in the Phase 4 STAR psoriatic arthritis study, supporting expansion of its immunology growth drivers.

Theme Impact 2

Related news

ChinaUnited States

Vor Biopharma's Telitacicept Shows Durable Responses in Phase 3 Myasthenia Gravis Analysis

Vor Biopharma reported a post hoc analysis from a China-based Phase 3 trial showing that telitacicept produced deep, durable clinical responses and was generally well tolerated over 48 weeks in adults with generalized myasthenia gravis. The analysis highlighted that most patients who reached minimal symptom expression maintained it and spent much of their remaining follow-up in this state. The new data reinforce the depth and durability of response but do not materially change the key near-term catalyst, the UPSTREAM global Phase 3 topline readout in 2027, or the central risk that global data might not match prior China experience. The results sit beside Vor's completion of enrollment in the global UPSTREAM Phase 3 gMG trial in early September 2026. Vor Biopharma's narrative projects $111.0 million revenue and $19.1 million earnings by 2029, implying an earnings decrease of $608.7 million from $627.8 million today, and forecasts a $39.00 fair value, a 109% upside to its current price.
About megatrends
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics Technology
VOR · Technology · Positive Post hoc Phase 3 analysis shows telitacicept produced deep, durable responses over 48 weeks in generalized myasthenia gravis, reinforcing the drug's clinical profile.
Read original ↗
Simply Wall St·6hRead more →
United StatesChinaDenmarkFrance
▲

Sanofi, Novartis and Novo Nordisk Lead Week of Multi-Billion-Dollar Healthcare Deals

A Delaware federal judge on Monday rejected requests from Pfizer, BioNTech and Moderna to dismiss lawsuits filed by Bayer's Monsanto unit over their use of US Patent No. 7,741,118, a patent related to mRNA technology, with Judge William Bryson saying the companies failed to prove the patent was invalid or not infringed by their COVID-19 vaccines. Sanofi agreed to a deal worth up to $8B, including $1B upfront, with Regeneron to jointly develop four long-acting immunology therapies, led by the clinical-stage IL-13 monoclonal antibody REGN20423. China's Abogen Biosciences signed a licensing and option agreement with Novartis worth up to $7.8B, comprising a $575 million upfront payment and up to approximately $7.2 billion in potential milestone payments if all options on all programs are exercised, covering an exclusive worldwide license to Abogen's lead asset ABO2203. Jiangsu Hengrui Pharmaceuticals agreed to license global rights to its experimental obesity drug HRS-1596 to Novo Nordisk in a deal worth up to $2.6B, with $300M upfront and the transaction expected to close in Q4 2026. Meanwhile, the S&P 500 Health Care Sector Index slipped 2.66% for the week, with Incyte down 6.93% and Regeneron down 6.71% among the top decliners, while McKesson rose 4.11% and Cardinal Health gained 3.67%.
About megatrends
Biotech & Genomic Medicine › RNA Therapeutics ▼Capital
Biotech & Genomic Medicine › mRNA Platforms ▼Capital
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Capital
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Capital
NOVN.SW · Demand · Positive Novartis signed a licensing and option agreement with Abogen worth up to $7.8B covering ABO2203.
SAN.PA · Demand · Positive Sanofi agreed to an up-to-$8B deal with Regeneron to jointly develop four long-acting immunology therapies.
Abogen Biosciences · Demand · Positive Abogen Biosciences licensed its lead asset ABO2203 to Novartis in a deal worth up to $7.8B.
22UA.XETRA · Regulation · Negative Delaware judge rejected BioNTech's motion to dismiss Monsanto's mRNA patent lawsuits over its COVID-19 vaccine.
600276.CG · Demand · Positive Hengrui licensed global rights to its obesity drug HRS-1596 to Novo Nordisk for up to $2.6B, with $300M upfront.
MRNA · Regulation · Negative Delaware judge rejected Moderna's motion to dismiss Monsanto's mRNA patent infringement lawsuits over its COVID-19 vaccine.
Read original ↗
Seeking Alpha·9hRead more →
United StatesEuropean UnionJapanChina
▲2

Johnson & Johnson Reports Sustained Phase 3 Skin Clearance for ICOTYDE in Plaque Psoriasis

Johnson & Johnson reported new Phase 3 results for its oral peptide ICOTYDE in plaque psoriasis at the 2026 EADV Congress, showing sustained skin clearance and improvement across multiple high-impact psoriasis sites, including in adolescent patients. Long-term data from the ICONIC-TOTAL study showed sustained skin clearance through Week 112 at high-impact sites such as the scalp, genital area, hands, feet and nails. The oral IL-23 inhibitor remains in clinical studies for other major inflammatory diseases beyond plaque psoriasis, including psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE is already approved in the U.S., Europe, Japan and China, and the key test ahead is how the evidence translates into prescribing and reimbursement decisions in those markets. Johnson & Johnson is a global healthcare group that develops prescription drugs, medical devices and consumer health products.
About megatrends
Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Demand
JNJ · Technology · Positive Phase 3 ICOTYDE data show sustained skin clearance through Week 112, supporting the oral IL-23 inhibitor's clinical profile.
Read original ↗
Simply Wall St·1dRead more →