Daratumumab is an anti-CD38 human monoclonal antibody therapy used in multiple myeloma treatment, including combination regimens in newly diagnosed and relapsed settings. It is marketed as Darzalex and Darzalex SC. The drug is prescription-only in major markets.
Johnson & Johnson raised its full-year forecast after stronger-than-expected quarterly results driven by cancer, immunology and neuroscience drugs. Sales were $24.56 billion and adjusted earnings were $2.46 per share, with Innovative Medicines sales rising 10.0% to $15.76 billion.
Johnson & Johnson shares hit a 52-week high after the company reported 2025 revenue of $94.19 billion and forecast 2026 revenue above $100 billion. The company also filed a shelf registration and said Innovative Medicine growth offset pressure from Stelara.
Johnson & Johnson reported strong Q4 2025 earnings with $2.46 adjusted EPS and $24.56 billion in sales, beating estimates. The company faces over 67,000 active talc lawsuits following recent trial losses while projecting 2026 sales of $100-101 billion and maintaining a robust pipeline with recent FDA approvals and breakthrough designations.
Orphan drug sales are projected to reach $400 billion by 2032, accounting for over 21% of prescription drug sales. Recent policy changes expanded IRA exemptions for multi-indication orphan drugs and reauthorized pediatric review vouchers. Johnson & Johnson's Darzalex leads orphan drug sales with $31 billion projected revenue.
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
Novel CELMoD agents are being evaluated to address T-cell exhaustion in multiple myeloma patients, while CAR T-cell therapy CARVYKTI shows longer-term survival benefits. Nearly 200,000 people in the U.S. live with this blood cancer.
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
The global pharmaceutical market reached nearly $1.7 trillion in value, with Johnson & Johnson leading prescription sales at approximately $55.8 billion while Merck & Co. topped research and development investment at $17.8 billion.
The Trump administration's pharmaceutical deals and TrumpRx program claim to lower drug prices, but analysis reveals limited savings, pre-existing investments, and weakened Medicare negotiation provisions that may cost billions.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07400744 |
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects |
NOT_YET_RECRUITING | PHASE1 |
| NCT06895512 |
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma |
NOT_YET_RECRUITING | PHASE3 |
| NCT06296121 |
A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma |
RECRUITING | PHASE3 |
| NCT05974969 |
A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects |
COMPLETED | PHASE1 |
| NCT05749276 |
Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM) |
NOT_YET_RECRUITING | PHASE1 |
| NCT05306587 |
Daratumumab Provided at Home Experience An Open, Single-center, Mixed-method Project. |
COMPLETED |
