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
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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
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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
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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
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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
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Anaphylm resubmitted after fixing every CRL deficiency; FDA classification and review clock are the remaining gating items
- Anaphylm FiledAnaphylaxis · epinephrine prodrug
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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
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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
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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
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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
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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
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Positive Phase 3 efficacy and funding support obefazimod's NDA, with FDA review and labeling now the central tests
- obefazimod Phase 3Ulcerative Colitis · enhanced expression of microRNA miR-124
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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
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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
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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
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Tacrolimus challenger with cleaner safety profile heads into Phase 3, but runway expires well before trial data arrives
- tegoprubart Phase 3Kidney Transplantation · CD40L costimulation blocker
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Rolling miv-cel BLA underway in stiff person syndrome; FDA's view of single-arm data remains decisive
- miv-cel Phase 3Generalized Myasthenia Gravis · CD19-targeting CAR T-cell therapy
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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
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BRIUMVI nearing $1B annual revenue with SC formulation and indication expansions as the growth ceiling test
- BRIUMVI Phase 3Myasthenia Gravis · anti-CD20 monoclonal antibody
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