Pharma Patent Cliffby readouts.io
Late-stage pipeline · Immunology

Late-stage immunology biotechs

$75.7B of 2025 immunology blockbuster sales lose US exclusivity by 2037, led by Dupixent, Skyrizi, Rinvoq. These 19 public biotechs have 44 immunology treatments in Phase 3 or filed with the FDA, 10 of them already filed.

Who is losing immunology revenue

2025 sales each company reports from tracked immunology treatments losing US exclusivity by 2037. Big pharma has spent $53.6B on 11 immunology acquisitions since 2023. See the deals →

19 biotechs with late-stage immunology treatments

Alumis ALMS

Oral TYK2 inhibitor files for psoriasis on clean Phase 3 data, but LUMUS miss narrows the franchise story to one approved indication

  • Envudeucitinib FiledPlaque Psoriasis · oral allosteric TYK2 inhibitor
  • Envudeucitinib FiledSjögren'S Syndrome · oral allosteric TYK2 inhibitor
  • envu FiledPlaque Psoriasis · allosteric TYK2 inhibitor
Read the thesis on Readouts →

Roivant Sciences ROIV

First-ever approved dermatomyositis therapy just launched; commercial uptake now determines whether a multi-indication TYK2/JAK1 platform compounds or stalls

  • Brepocitinib FiledDermatomyositis · JAK1 and TYK2 inhibitor
  • Brepocitinib Phase 3Non-Infectious Uveitis · JAK1 and TYK2 inhibitor
  • Brepocitinib Phase 3Lichen Planopilaris · JAK1 and TYK2 inhibitor
  • Brepocitinib Phase 3Cutaneous Sarcoidosis · JAK1 and TYK2 inhibitor
  • LISRAYA Phase 3Non-Infectious Uveitis · TYK2/JAK1 inhibitor
  • LISRAYA Phase 3Lichen Planopilaris · TYK2/JAK1 inhibitor
  • LISRAYA Phase 3Cutaneous Sarcoidosis · TYK2/JAK1 inhibitor
  • IMVT-1402 Phase 3Rheumatoid Arthritis · FcRn inhibitor
  • IMVT-1402 Phase 3Cutaneous Lupus Erythematosus · FcRn inhibitor
  • IMVT-1402 Phase 3Myasthenia Gravis · FcRn inhibitor
  • IMVT-1402 Phase 3Graves Disease · FcRn inhibitor
  • IMVT-1402 Phase 3Sjögren Disease · FcRn inhibitor
  • IMVT-1402 Phase 3Sjogren'S Disease · FcRn inhibitor
Read the thesis on Readouts →

Cabaletta Bio CABA

Single-arm BLA for a CAR-T that erases myositis in small cohorts: does FDA accept the data without a randomized control?

  • rese-cel FiledMyositis · CD19-targeted CAAR-T cell therapy
  • rese-cel Phase 3Dermatomyositis · CD19-targeted CAAR-T cell therapy
  • rese-cel Phase 3Antisynthetase Syndrome · CD19-targeted CAAR-T cell therapy
Read the thesis on Readouts →

MoonLake Immunotherapeutics MLTX

Dual Phase 3 wins in HS and PsA position sonelokimab for multi-indication filing; BLA acceptance and label scope are the make-or-break conditions

  • sonelokimab FiledHidradenitis Suppurativa · anti-IL-17A/F nanobody
  • sonelokimab Phase 3Psoriatic Arthritis · anti-IL-17A/F nanobody
Read the thesis on Readouts →

Viridian Therapeutics VRDN

Lumvoa approved and launched in TED; elegrobart Phase 3 wins set up a second BLA; commercial execution against Tepezza is now the deciding test

  • veligrotug FiledThyroid Eye Disease · anti-IGF-1R monoclonal antibody
  • elegrobart Phase 3Thyroid Eye Disease · anti-IGF-1R monoclonal antibody
Read the thesis on Readouts →

Insight Molecular Diagnostics IMDX

Medicare coverage unlocked, FDA clearance pending; GraftAssure's commercial future depends on authorization before cash runs out

  • GraftAssure FiledKidney Transplant Rejection · donor-derived cell-free DNA molecular diagnostic assay
Read the thesis on Readouts →

Ionis Pharmaceuticals IONS

Ionis has three approved drugs and two fresh Phase 3 wins, but the hepatitis B functional-cure PDUFA is the single event that rerates the stock

  • DAWNZERA FiledHereditary Angioedema · plasma kallikrein inhibitor antisense oligonucleotide
Read the thesis on Readouts →

Cartesian Therapeutics RNAC

Outpatient mRNA CAR-T skips lymphodepletion entirely; Phase 3 AURORA tests whether that tolerability comes at the cost of efficacy in MG

  • Descartes-08 Phase 3Myasthenia Gravis · anti-BCMA mRNA CAR-T cell therapy
  • Descartes-08 Phase 3Systemic Lupus Erythematosus · anti-BCMA mRNA CAR-T cell therapy
  • Descartes-08 Phase 3Myositis · anti-BCMA mRNA CAR-T cell therapy
  • Descartes-08 Phase 3Antisynthetase Syndrome · anti-BCMA mRNA CAR-T cell therapy
  • Descartes-08 Phase 3Juvenile Dermatomyositis · anti-BCMA mRNA CAR-T cell therapy
Read the thesis on Readouts →

Immunovant IMVT

IMVT-1402 runs five autoimmune trials after batoclimab's collapse; RA and MG registrational readouts determine platform survival

  • IMVT-1402 Phase 3Rheumatoid Arthritis · FcRn inhibitor
  • IMVT-1402 Phase 3Generalized Myasthenia Gravis · FcRn inhibitor
  • batoclimab Phase 3Thyroid Eye Disease · FcRn inhibitor
Read the thesis on Readouts →

Nektar Therapeutics NKTR

Regulatory T-cell biology meets a crowded atopic dermatitis field: Phase 3 data in mid-2028 determines whether rezpegaldesleukin earns a place among established biologics

  • rezpegaldesleukin Phase 3Atopic Dermatitis · PEGylated IL-2 Treg agonist
  • rezpegaldesleukin Phase 3Alopecia Areata · PEGylated IL-2 Treg agonist
Read the thesis on Readouts →

Artiva Biotherapeutics ARTV

Allogeneic NK cell therapy for refractory RA shows 71% ACR50 in small Phase 2a cohort; Phase 3 RCT will prove or disprove whether outpatient B-cell reset scales

  • AlloNK Phase 3Rheumatoid Arthritis · ADCC-enhancing allogeneic NK cell therapy
Read the thesis on Readouts →

Avalo Therapeutics AVTX

Phase 2 HS win and $472M war chest position abdakibart for Phase 3, contingent on replicating that signal at registrational scale

  • abdakibart Phase 3Hidradenitis Suppurativa · dual anti-IL-1α/β monoclonal antibody
Read the thesis on Readouts →

Biohaven BHVN

Biohaven pivots to BHV-1300 in Graves' disease after troriluzole CRL and OCD failure, with a $795M Kv7 licensing deal buying time for a 2027 Phase 3 readout

  • BHV-1300 Phase 3Graves' Disease
Read the thesis on Readouts →

Mesoblast Limited MESO

Ryoncil's $115M launch year funds the rexlemestrocel-L CLBP Phase 3 bet; the readout determines whether Mesoblast is a commercial platform or a one-product story

  • Ryoncil Phase 3Steroid-Refractory Acute Graft Versus Host Disease · mesenchymal stem cell therapy
Read the thesis on Readouts →

Filed treatments are listed first. This shows where late-stage treatments are being developed, not which companies will be acquired. Pipeline data and summaries from Readouts as of 29 September 2026; companies already acquired are left out.

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