This week’s Immunology edition covers major regulatory milestones, late-stage clinical progress, and platform partnerships that expand access to specialized therapies across immunology and dermatology.
In Today’s Newsletter
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In Today’s Newsletter
💡 Novartis ianalumab wins FDA Breakthrough Therapy [1] [US • 16 Jan 2026]
https://www.novartis.com/news/media-releases/novartis-ianalumab-receives-fda-breakthrough-therapy-designation-sjogrens-disease
Context: Fully human mAb that depletes B cells and blocks BAFF-R; supported by multiple Phase 3 studies.
Key point: FDA Breakthrough Therapy designation for Sjögren’s disease, with global submissions planned starting early 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Sobi’s Aspaveli gets EC nod for C3G and primary IC-MPGN [2] [EU • 16 Jan 2026]
https://www.sobi.com/en/press-releases/sobi-receives-european-commission-approval-aspavelir-pegcetacoplan-treatment-c3g-and-primary-ic-mpgn-2418695
Context: Targeted C3/C3b inhibitor; approval follows Dec 2025 CHMP positive opinion and Phase 3 VALIANT results.
Key point: First approved treatment for primary IC-MPGN and for C3G/IC-MPGN in patients 12–17, in combination with RAS inhibitor unless not tolerated.
Implication: Introduces competition that may affect pricing and formulary access.
🛡️ VYVGART IV sBLA accepted with Priority Review in seronegative gMG [3] [US • 13 Jan 2026]
https://www.pharmiweb.com/press-release/2026-01-14/argenx-announces-fda-acceptance-of-supplemental-biologics-license-application-with-priority-review-for-vyvgart-in-achr-ab-seronegative-gmg
Context: Phase 3 ADAPT SERON met primary endpoint on MG-ADL at 4 weeks; n=119; safety consistent with prior use.
Key point: FDA acceptance with Priority Review for adults with AChR-Ab seronegative gMG, PDUFA 10 May 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
📺 Skyrizi tops 2025 TV ad spend, Tremfya close behind [4] [16 Jan 2026]
https://www.fiercepharma.com/marketing/abbvies-skyrizi-takes-full-year-tv-ad-spending-crown-yet-again-jjs-tremfya-hot-pursuit
Context: iSpot.TV analysis of 2025 US national TV spend across top 10 drug advertisers.
Key point: Skyrizi led at ~$439.6M, Tremfya ~$431M, Rinvoq ~$376.4M; total top-10 spend ~$2.67B.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.
🔥 Caldera debuts with $112.5M and IL-23p19/TL1A bispecific for IBD [5] [14 Jan 2026]
https://www.fiercebiotech.com/biotech/caldera-launches-112m-former-morphic-ceo-and-ibd-drug-china
Context: CLD-423 licensed from Qyuns Therapeutics; Phase 1 in healthy volunteers underway.
Key point: Strategy targets dual IL-23p19 and TL1A pathways, following sector interest in TL1A programs.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
🧪 eNavvi partners with SandsRx for compounded therapies [6] [US • 19 Jan 2026]
https://www.prnewswire.com/news-releases/enavvi-partners-with-sandsrx-to-expand-sterile-and-non-sterile-compounding-for-dermatology-weight-management-and-hrt-302664304.html
Context: Adds PCAB-accredited sterile and non-sterile compounding to eNavvi’s marketplace across dermatology, urology, weight management, and HRT.
Key point: Partnership aims to simplify access to customized formulations aligned with USP <795>/<797>.
Implication: Access programs: May expand screening, initiation, and follow-up at scale.
🧴 Almirall outlines 2026 derm pipeline expansion at JPM [7] [14 Jan 2026]
https://www.almirall.com/newsroom/news/almirall-presents-r-d-pipeline-advances-supported-by-sustained-growth-and-leadership-in-medical-dermatology-at-j.p.-morgan-healthcare-conference
Context: Focus on high-need derm indications; multiple PoC/Phase 2 studies ongoing and planned.
Key point: Three new PoC starts in 2026, Phase 1 bispecific (IL-13/OX-40L) for AD in H1 2026, plus lifecycle work on lebrikizumab and tildrakizumab.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
Why it matters
- Targeted options in Sjögren’s and complement-driven kidney disease are moving closer to patients.
- Expansion of FcRn and complement pathways across indications could reshape autoimmune standards of care.
- TL1A and IL-23p19 remain hot IBD targets, now including bispecific strategies.
- Heavy DTC spend in immunology sustains market share battles and patient activation.
- Pipeline depth in medical dermatology points to continued biologics growth and broader patient access.
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FAQ
What is ianalumab’s mechanism and status in Sjögren’s?
Ianalumab is a fully human mAb that depletes B cells and blocks BAFF-R. It received FDA Breakthrough Therapy designation for Sjögren’s, with global filings planned starting early 2026 [1].
What did the EC approve for Aspaveli?
Aspaveli (pegcetacoplan) was approved for C3G and primary IC-MPGN in patients aged 12 and older, typically with a RAS inhibitor unless not tolerated, following positive VALIANT data [2].
What is the scope of argenx’s VYVGART filing?
The FDA accepted an sBLA with Priority Review for VYVGART IV in adults with AChR-Ab seronegative gMG. PDUFA is 10 May 2026, supported by the Phase 3 ADAPT SERON study [3].
Who led 2025 US TV drug ad spending?
AbbVie’s Skyrizi ranked first, J&J’s Tremfya second, and AbbVie’s Rinvoq third. Combined top-10 spend was about $2.67B, per iSpot.TV data reported by FiercePharma [4].
What is Caldera’s lead asset and target profile?
CLD-423 is a bispecific targeting IL-23p19 and TL1A for IBD, licensed from Qyuns, and already in Phase 1. The company raised $112.5M across Series A rounds [5].
Which pipeline moves did Almirall highlight for 2026?
Three new PoC studies, a Phase 1 IL-13/OX-40L bispecific for AD in H1 2026, and additional studies to broaden access for lebrikizumab and tildrakizumab [7].
Entities / Keywords
Novartis; ianalumab; BAFF-R; Sjögren’s disease | Sobi; Apellis; Aspaveli; pegcetacoplan; C3G; IC-MPGN; VALIANT | argenx; VYVGART; efgartigimod; gMG; ADAPT SERON | AbbVie; Skyrizi; Rinvoq; J&J; Tremfya; DTC advertising | Caldera Therapeutics; Qyuns Therapeutics; CLD-423; IL-23p19; TL1A; IBD | eNavvi; SandsRx; PCAB; USP <795>/<797> | Almirall; lebrikizumab (Ebglyss); tildrakizumab (Ilumetri); IL-13/OX-40L.
References
- https://www.novartis.com/news/media-releases/novartis-ianalumab-receives-fda-breakthrough-therapy-designation-sjogrens-disease
- https://www.sobi.com/en/press-releases/sobi-receives-european-commission-approval-aspavelir-pegcetacoplan-treatment-c3g-and-primary-ic-mpgn-2418695
- https://www.pharmiweb.com/press-release/2026-01-14/argenx-announces-fda-acceptance-of-supplemental-biologics-license-application-with-priority-review-for-vyvgart-in-achr-ab-seronegative-gmg
- https://www.fiercepharma.com/marketing/abbvies-skyrizi-takes-full-year-tv-ad-spending-crown-yet-again-jjs-tremfya-hot-pursuit
- https://www.fiercebiotech.com/biotech/caldera-launches-112m-former-morphic-ceo-and-ibd-drug-china
- https://www.prnewswire.com/news-releases/enavvi-partners-with-sandsrx-to-expand-sterile-and-non-sterile-compounding-for-dermatology-weight-management-and-hrt-302664304.html
- https://www.almirall.com/newsroom/news/almirall-presents-r-d-pipeline-advances-supported-by-sustained-growth-and-leadership-in-medical-dermatology-at-j.p.-morgan-healthcare-conference