This weekly Immunology update covers regulatory actions, clinical progress, data readouts, and partnerships across autoimmune and IBD.
In Today’s Newsletter
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In Today’s Newsletter
🧠 Rilzabrutinib lands US Breakthrough Therapy in warm AIHA, Japan orphan tag [1] [EU • 09 Feb 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-09-06-00-00-3234232
Context: Based on ongoing Phase 2b LUMINA 2 (NCT05002777); Phase 3 LUMINA 3 (NCT07086976) underway.
Key point: FDA Breakthrough Therapy granted for Wayrilz (rilzabrutinib) in warm AIHA, and orphan designation in Japan for same condition.
Implication: Introduces competition that may affect pricing and formulary access.
💰 AbbVie 2025 results, 2026 guide, and multiple pipeline moves [2] [US • 04 Feb 2026]
https://news.abbvie.com/2026-02-04-AbbVie-Reports-Full-Year-and-Fourth-Quarter-2025-Financial-Results
Context: 2025 net revenues $61.16B; Immunology $30.41B; Skyrizi $17.56B; Rinvoq $8.30B; GAAP EPS $2.36; Adjusted EPS $10.00.
Key point: Provides 2026 adjusted EPS guidance $14.37–$14.57 and reports recent regulatory and BD updates including Epkinly FL approval and EPCORE readouts.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Alvotech hits PK endpoints for proposed Entyvio biosimilars (IV and SC) [3] [05 Feb 2026]
https://investors.alvotech.com/news-releases/news-release-details/alvotech-announces-positive-top-line-results-pivotal
Context: Randomized, double-blind, single-dose, 3-arm PK study in healthy adults for AVT80 (SC) vs Entyvio; supports AVT16 (IV) and AVT80 per regulatory advice.
Key point: Study met all primary PK similarity endpoints, with supportive safety, tolerability, immunogenicity.
Implication: Introduces competition that may affect pricing and formulary access.
🔁 Lilly eyes GLP-1 expansion into I&I indications (combination trials) [4] [04 Feb 2026]
https://www.biospace.com/drug-development/lilly-eyes-pipeline-in-a-product-as-glp-1s-move-into-i-i
Context: Earnings call commentary outlines tirzepatide combinations with Taltz and Omvoh, plus brenipatide in asthma.
Key point: Company signals a pipeline-in-a-product strategy for incretins across PsA, Crohn’s, UC, and asthma (endpoints not specified).
Implication: Signals pipeline investment and modality expansion.
🇨🇳 VELSIPITY approved in China for moderately to severely active UC [5] [06 Feb 2026]
https://www.manilatimes.net/2026/02/06/tmt-newswire/pr-newswire/everest-medicines-announces-china-nmpa-approval-of-velsipity-for-adults-with-moderately-to-severely-active-ulcerative-colitis/2273082
Context: Approval supported by Asian Phase 3 ENLIGHT UC and global ELEVATE UC 12/52 programs.
Key point: China NMPA approved etrasimod arginine tablets for adult UC after inadequate response or intolerance to prior therapy.
Implication: May expand screening, initiation, and follow-up at scale.
🌟 Brepocitinib shows superiority in Phase 2 cutaneous sarcoidosis (BEACON) [6]
https://www.dermatologytimes.com/view/brepocitinib-demonstrates-superior-efficacy-in-phase-2-beacon-trial-for-cutaneous-sarcoidosis
Context: 16-week, randomized, placebo-controlled Phase 2 across 15 US sites; dual TYK2/JAK1 inhibitor.
Key point: Superior lesion clearance and PRO improvements vs placebo with favorable tolerability; Phase 3 planned in 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🤝 Innovent–Lilly strike global oncology and immunology pact [7] [08 Feb 2026]
https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=578
Context: Seventh collaboration between companies; Innovent leads to POC in China; Lilly takes ex-Greater China rights.
Key point: $350M upfront, up to ~$8.5B in milestones, plus tiered ex-Greater China royalties.
Implication: Signals pipeline investment and modality expansion.
📣 Allergy/Immunology misinformation draws high engagement online [8] [US • 09 Feb 2026]
https://www.prnewswire.com/news-releases/allergyimmunology-misinformation-often-goes-unchallenged-in-social-media-landscape-302682761.html
Context: Cross-sectional analysis of 347 high-engagement posts across major platforms, Jan–Mar 2025.
Key point: 62% of top comments were supportive or neutral to misinformation; natural remedies and IgG testing were common themes.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
- Breakthrough and orphan designations can accelerate timelines in rare hematology, potentially reshaping treatment sequencing.
- Biosimilar progress against vedolizumab may pressure IBD pricing and access upon approval.
- China’s etrasimod approval expands advanced UC options in a large and growing market.
- Incretin combinations in I&I could blur lines between metabolic and immune care models.
- Robust Phase 2 dermatology data in a neglected granulomatous disease may catalyze investment and trial activity.
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FAQ
What did the FDA grant to Sanofi’s Wayrilz (rilzabrutinib) in warm AIHA?
FDA Breakthrough Therapy in the US, with Japan orphan designation for the same indication, supported by LUMINA 2 data, while Phase 3 LUMINA 3 is underway [1].
How strong were AbbVie’s 2025 immunology sales, and what is 2026 guidance?
Immunology delivered $30.41B in 2025 with Skyrizi at $17.56B and Rinvoq at $8.30B. 2026 adjusted EPS guidance is $14.37–$14.57 (excludes acquired IPR&D impacts) [2].
What did Alvotech’s PK study show for proposed Entyvio biosimilars?
The AVT80 PK study met all primary endpoints and is considered pivotal to support clinical similarity for both AVT16 (IV) and AVT80 (SC), per regulatory advice [3].
What is newly approved for UC in China?
The NMPA approved VELSIPITY (etrasimod arginine tablets) for adults with moderately to severely active UC after inadequate response or intolerance to prior therapy, based on ENLIGHT UC and ELEVATE UC programs [5].
What signal did Priovant’s brepocitinib show in cutaneous sarcoidosis?
Phase 2 BEACON demonstrated superior efficacy vs placebo with aligned physician and patient-reported outcomes and favorable tolerability; Phase 3 is planned in 2026 [6].
What are the terms of the Innovent–Lilly collaboration?
Innovent receives $350M upfront and is eligible for up to ~$8.5B in milestones, with Lilly holding ex-Greater China rights after POC and Innovent retaining Greater China rights [7].
Entities / Keywords
Sanofi; Wayrilz; rilzabrutinib; BTKi; warm AIHA • AbbVie; Skyrizi; Rinvoq; Epkinly; EPCORE • Alvotech; AVT16; AVT80; vedolizumab; Entyvio biosimilar • Eli Lilly; tirzepatide; Zepbound; Taltz; Omvoh; brenipatide • Everest Medicines; etrasimod; VELSIPITY; NMPA; ulcerative colitis • Priovant Therapeutics; brepocitinib; TYK2/JAK1; BEACON; cutaneous sarcoidosis • Innovent Biologics; global collaboration; milestones • AAAAI; misinformation; IgG testing; natural remedies.
References
- https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-09-06-00-00-3234232
- https://news.abbvie.com/2026-02-04-AbbVie-Reports-Full-Year-and-Fourth-Quarter-2025-Financial-Results
- https://investors.alvotech.com/news-releases/news-release-details/alvotech-announces-positive-top-line-results-pivotal
- https://www.biospace.com/drug-development/lilly-eyes-pipeline-in-a-product-as-glp-1s-move-into-i-i
- https://www.manilatimes.net/2026/02/06/tmt-newswire/pr-newswire/everest-medicines-announces-china-nmpa-approval-of-velsipity-for-adults-with-moderately-to-severely-active-ulcerative-colitis/2273082
- https://www.dermatologytimes.com/view/brepocitinib-demonstrates-superior-efficacy-in-phase-2-beacon-trial-for-cutaneous-sarcoidosis
- https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=578
- https://www.prnewswire.com/news-releases/allergyimmunology-misinformation-often-goes-unchallenged-in-social-media-landscape-302682761.html