Merck KGaA (MRK.DE) — Upcoming Catalysts

FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Merck KGaA, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.

For informational purposes only — not investment advice. Track MRK.DE live on Mooboard →

Later5

  • May 28, 2027
    Merck KGaA(MRK.DE)Phase 2/3 readout
    Nirogacestat oral tablet · Phase 2 · Desmoid Tumor; Aggressive Fibromatosis
    NCT07170644: A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF). Primary completion 2027-05-28 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Jul 5, 2028
    Merck KGaA(MRK.DE)Phase 2/3 readout
    hMG · Phase 3 · Infertility
    NCT07340827: A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA). Primary completion 2028-07-05 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 12, 2028
    Merck KGaA(MRK.DE)Phase 2/3 readout
    M5049 low dose · Phase 2 · Systemic Lupus Erythematosus
    NCT05540327: The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE). Primary completion 2028-08-12 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Aug 23, 2028
    Merck KGaA(MRK.DE)Phase 2/3 readout
    Cladribine Low Dose · Phase 3 · Generalized Myasthenia Gravis
    NCT06463587: Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad). Primary completion 2028-08-23 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Nov 22, 2029
    Merck KGaA(MRK.DE)Phase 2/3 readout
    Pimicotinib · Phase 2 · Tenosynovial Giant Cell Tumor
    NCT07499362: Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER). Primary completion 2029-11-22 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗

How Merck KGaA has moved — past-year price reactions

How binary is MRK.DE? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.

1%
typical day (1Y)
1
±10% days
29.5%
annualized vol
253
trading days
Largest single-day moves
  • +10.1%2025-10-01no matched headline
  • -8%2026-03-05no matched headline
  • +7.2%2026-05-13no matched headline
  • +5.2%2026-04-08no matched headline
  • +5%2025-11-13no matched headline
  • +4.9%2026-06-25no matched headline

Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.

Merck KGaA — active clinical pipeline

Merck KGaA's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.

11 assets11 programsPh1 4Ph2 4Ph3 2· 1 post-marketing (Ph4)
AreasOncologyAutoimmuneOther
Cladribine Low DoseAutoimmune
Phase 3
Generalized Myasthenia Gravis
hMGOther · FSHR/LHCGR
Phase 3
Infertility
M5049 low doseAutoimmune
Phase 2
Systemic Lupus Erythematosus
Mirdametinib (PD-0325901) oral capsule or dispersible tabletOther
Phase 2
Plexiform Neurofibroma
Nirogacestat oral tabletOncology
Phase 2
Desmoid Tumor
PimicotinibOncology
Phase 2
Tenosynovial Giant Cell Tumor
M5542Other
Phase 1
Healthy volunteers
M9140Oncology
Phase 1
Solid Tumors
Mirdametinib (MEK Inhibitor)Other · MAP2K1/2K2
Phase 1
Hepatic Impairment
SW-682Oncology
Phase 1
Advanced Solid Tumor

Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).

See the full biopharma catalyst calendar across all covered companies.