Brepocitinib (VALOR) — Strong Phase III Results in Dermatomyositis
VALOR hit all 10 ranked endpoints with highly significant, consistent results; clear dose response supporting 30 mg as optimal. Rapid, deep, broad clinical benefit on mean TIS versus placebo; >33% of brepo 30 patients achieved both major TIS responses and minimal/no steroid burden at week 52; >50% achieved TIS40 with very low dose oral steroids. NDA filing on track for first half of next year.
Batoclimab / 1402 — Durable Remission Signals in Graves' Disease
In a 25-patient cohort, 20/25 responders after 12 weeks (high dose), 18/25 after low-dose phase, and 17/21 responders at week 48 off drug (6 months). Nearly half of off-drug responders were fully off antithyroid drugs (ATDs) and >75% were on only the lowest ATD doses or off ATDs. TRAb reductions were durable despite IgG returning toward baseline by week 48; deeper IgG suppression (>70% reduction) associated with ~3x higher off-ATD rates vs <70%.
Large Late-Stage Pipeline and Near-Term Catalyst Runway
Company highlights 11 potentially registrational trials and a stacked 36-month catalyst runway (DM, NIU, multiple 1402 indications including Graves', MG, CIDP, D2T RA, Sjögren's, CLE). Several readouts anticipated in 2026–2027 (e.g., NIU and some 1402 programs).
Strong Balance Sheet and Capital Actions
$4.4 billion in cash and cash equivalents, no debt, loss from continuing operations net of tax of $166 million for the quarter. Company authorized a $500 million share repurchase and has materially reduced share count via buybacks.
Immunovant / 1402 Program Momentum
Initiated or running potentially registrational trials across Graves', myasthenia gravis, CIDP, difficult-to-treat RA and Sjögren's, plus a POC trial in CLE — positioning 1402 for multiple blockbuster opportunities.
Legal Progress — Favorable Rulings and Trial Calendar
Favorable Markman ruling in the Pfizer/Genevant case; Moderna jury trial currently scheduled for March 2026. Multiple international (OUS) proceedings and hearings expected in 1H 2026.
Pulmovant (mosli) — Meaningful PVR Reduction in PH
Mosli showed a 38% PVR reduction in pulmonary hypertension trials; Phase II PH-ILD study readout expected in H2 next year, with cautious optimism on translatability from PAH data.