- Trial Phase
- Approved (multiple FDA-approved multiple-myeloma indications); additional label-expansion Phase 3 studies completed.
- Time to Market
- Already approved and on the market — DARZALEX (IV) since Nov 2015 and DARZALEX FASPRO (subcutaneous) since May 2020; label expansion for newly diagnosed multiple myeloma added ~Jan 2026.
- Why 4/10
- No hard, dated binary for DARZALEX in the next ~12 months — it is already approved and marketed (IV since Nov 2015, FASPRO subcutaneous since May 2020, latest label expansion ~Jan 2026), and the completed Phase 3 smoldering-myeloma study (NCT03301220) has no scheduled FDA decision in the local data — so the score stays at the approved-commercial default of 4 (steady grower, but quarterly sales are not a binary catalyst and JNJ is a diversified mega-cap).
For JNJ shareholders, DARZALEX is a cash-cow growth driver, not a binary — treat it as part of the Innovative Medicine growth story (with CARVYKTI, TREMFYA, SPRAVATO) that supported the FY2026 guidance raise, and watch each Genmab 6-K for quarterly DARZALEX net sales as the cleanest read on the franchise. The bigger near-term event to track is competitive: Bristol Myers' iberdomide + daratumumab + dexamethasone PDUFA landed Aug 17, 2026, and BMY's bb2121 CAR-T Phase 3 readout is pending.
Price Chart
Executive Summary
DARZALEX (daratumumab) is the standard-of-care backbone of multiple-myeloma therapy, sold by Johnson & Johnson's Janssen unit under a license from Genmab, which reports the product's worldwide net sales quarterly and takes royalties. The drug is approved in multiple myeloma indications (IV form since Nov 2015, subcutaneous FASPRO since May 2020, plus a 2026 label expansion for newly diagnosed patients), and it keeps growing: worldwide net sales were USD 4,207M in Q2 2026 (US $2,435M, rest-of-world $1,772M) after $3.964B in Q1 2026, and J&J's Q2 2026 earnings analysis named DARZALEX a key driver behind its raised FY2026 guidance. The bull case is a proven, growing, multi-indication franchise with no near-term binary risk; the bear case is competition (BMS' iberdomide combo PDUFA Aug 17, 2026 and CAR-T rivals), eventual biosimilar erosion, and the fact that for a ~$260/share mega-cap there is no single DARZALEX catalyst to trade around.
How It Works
Daratumumab is an engineered antibody that grabs onto a protein called CD38 that sits in high density on myeloma (plasma) cancer cells; attaching to it flags the cancer cells so the patient's own immune system destroys them, and it also kills cells directly. DARZALEX FASPRO is the same antibody formulated for a quick shot under the skin — it includes an enzyme called rHuPH20 (per trial drug naming "daratumumab + rHuPH20") that helps the liquid spread, replacing the long intravenous infusion.
Trial Status
Marketed blockbuster. Per local ClinicalTrials.gov data, Janssen-led Phase 3 studies that have COMPLETED include subcutaneous daratumumab vs active monitoring in high-risk smoldering myeloma (NCT03301220), daratumumab + lenalidomide maintenance in MRD-positive patients post-transplant (NCT03901963), and D-VRd vs VRd in newly diagnosed myeloma not planned for transplant (NCT03652064). FDA actions logged this session: supplemental efficacy approval for IV daratumumab on 2025-04-10 (JNJ) and a ~Jan 2026 sBLA approval of DARZALEX FASPRO + bortezomib/lenalidomide/dexamethasone for newly diagnosed myeloma.
The Two-Sided Case
Upcoming Catalysts
- Next quarterly DARZALEX net-sales disclosure in Genmab's 6-K and J&J's earnings (steady-state, non-binary revenue updates)
- Potential FDA submission/decision on the completed Phase 3 smoldering-myeloma study (NCT03301220, SC daratumumab vs active monitoring) — unscheduled in local data
- Competitive readouts: BMS iberdomide + daratumumab + dex PDUFA (2026-08-17) and BMS bb2121 CAR-T Phase 3 results pending
- J&J pipeline reads on adjacent myeloma assets (CARVYKTI JNJ-68284528) that shape the franchise's competitive moat
Source Filing
The SecBot filing or press-release report that triggered this drug report:
JOHNSON & JOHNSON 8-K JNJ ·Originating report