This biweekly Immunology video recap summarizes key regulatory actions, late-stage clinical progress, and notable data releases across autoimmune, cancer, and inflammatory conditions, with select policy and access updates.
🎯 Watch Our Video Summary Capturing Immunology News from the Last Two Weeks
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- Week 28 January-3 February 2026
- Week 4-10 February 2026
📚 Find your one-stop page for the full Immunology archive.
Top Stories Covered In This Video
Chapters
0:00 Introduction
0:08 AstraZeneca: FDA issued a CRL for Saphnelo SC in SLE, AZ resubmitted, decision expected H1 2026
0:40 AstraZeneca: Imfinzi plus FLOT recommended in EU for perioperative early gastric/GEJ cancer with EFS and OS benefit
1:12 Sanofi: Rezurock received EU CHMP positive opinion for conditional approval in late-line chronic GVHD
1:37 Biogen: Litifilimab got FDA Breakthrough Therapy for cutaneous lupus erythematosus based on Phase 2 data
2:07 Galderma: FDA accepted BLA resubmission for relabotulinumtoxinA for facial lines
2:32 Sanofi: Rilzabrutinib received FDA Breakthrough Therapy for wAIHA and orphan designation in Japan
2:54 Everest Medicines: China NMPA approved VELSIPITY (etrasimod) for moderate-to-severe ulcerative colitis
3:28 Priovant Therapeutics: Brepocitinib showed positive Phase 2 results in cutaneous sarcoidosis, Phase 3 planned
4:00 How to reach us
Transcript
Welcome to the latest edition of Immunology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
AstraZeneca reports that the FDA issued a Complete Response Letter for subcutaneous Saphnelo for adult systemic lupus erythematosus. The BLA was supported by an interim analysis of the Phase 3 TULIP SC study, and a subsequent full analysis confirmed the primary endpoint. AstraZeneca has provided the requested information and is targeting a decision in H1 2026. Intravenous Saphnelo remains available.
The EU CHMP issued a positive opinion for Imfinzi combined with FLOT as a perioperative regimen in resectable early or locally advanced gastric or gastroesophageal junction cancer. The Phase 3 MATTERHORN trial demonstrated an event free survival hazard ratio of 0.71 and an overall survival hazard ratio of 0.78, with safety consistent with known profiles.
The CHMP also delivered a positive opinion for Rezurock, recommending conditional marketing authorisation for adults and adolescents aged 12 years and older with late line chronic graft versus host disease. The decision followed re examination and drew on multiple studies and real world evidence, with a confirmatory randomized controlled trial planned.
Biogen’s litifilimab, also known as BIIB059, received FDA Breakthrough Therapy designation for cutaneous lupus erythematosus. The designation reflects the totality of evidence, including the Phase 2 LILAC study that reduced skin disease activity versus placebo, and recognizes litifilimab as a first in class BDCA2 targeting monoclonal antibody.
The FDA accepted Galderma’s BLA resubmission for relabotulinumtoxinA, a ready to use liquid neuromodulator for glabellar and lateral canthal lines. The resubmission is supported by the READY Phase 3 program with more than 1,900 participants, which reported rapid onset and effects lasting up to six months.
Sanofi’s rilzabrutinib received FDA Breakthrough Therapy designation for warm autoimmune hemolytic anemia and orphan designation in Japan. The designations are based on the ongoing LUMINA 2 Phase 2b study, and the LUMINA 3 Phase 3 study is underway versus placebo.
China’s NMPA approved Velsipity, etrasimod, for adults with moderately to severely active ulcerative colitis who had an inadequate response to conventional or biologic therapy. The approval was supported by ENLIGHT UC in Asia and the global ELEVATE UC 12 and ELEVATE UC 52 studies, and confirmed a safety profile consistent with prior research.
Etrasimod is a once daily selective S1P receptor modulator. Priovant reported positive Phase 2 BEACON results for brepocitinib in cutaneous sarcoidosis. In this 16 week randomized, placebo controlled trial across 15 US sites, the 45 mg dose improved the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity score versus placebo, aligned with patient reported outcomes, and showed favorable tolerability. A Phase 3 program is planned.
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Why it matters
- Perioperative immunotherapy in gastric/GEJ cancer could shift EU standards of care [2].
- Autoimmune dermatology momentum spans SLE, CLE, and sarcoidosis with novel mechanisms [1][4][8].
- BTK inhibition advances in hematology autoimmunity with expedited paths in wAIHA [6].
- China’s approval of an oral S1P for UC broadens regional access to advanced therapies [7].
🗓️ Explore details and sources
- Week 28 January-3 February 2026
- Week 4-10 February 2026
📚 Find your one-stop page for the full Immunology archive.
FAQ
What is the status of Saphnelo for subcutaneous use in the US?
FDA issued a CRL; AstraZeneca has provided requested info and anticipates an H1 2026 decision. IV Saphnelo remains available [1].
What did the EU CHMP recommend for Imfinzi in gastric/GEJ cancer?
Positive opinion for perioperative Imfinzi plus FLOT in resectable early/locally advanced disease, based on EFS and OS benefits in MATTERHORN [2].
Has Rezurock been approved in the EU?
Not yet. CHMP issued a positive opinion for conditional approval in late-line chronic GVHD, pending European Commission decision [3].
Which lupus program received US FDA Breakthrough Therapy?
Biogen’s litifilimab (BIIB059) for cutaneous lupus erythematosus, backed by Phase 2 LILAC data showing skin activity reductions [4].
What new regulatory designations did rilzabrutinib receive?
FDA Breakthrough Therapy for warm AIHA and orphan designation in Japan, supported by LUMINA-2 data and an ongoing Phase 3 LUMINA-3 trial [6].
Where was etrasimod newly approved and for whom?
China’s NMPA approved VELSIPITY for adults with moderately to severely active UC with inadequate response to conventional or biologic therapy [7].
Entities / Keywords
AstraZeneca; Saphnelo (anifrolumab); TULIP-SC; FDA CRL • AstraZeneca; Imfinzi (durvalumab); FLOT; MATTERHORN; CHMP • Sanofi; Rezurock (belumosudil); chronic GVHD; conditional approval • Biogen; litifilimab (BIIB059); BDCA2; CLE; FDA Breakthrough Therapy • Galderma; relabotulinumtoxinA; BLA resubmission; READY program • Sanofi; rilzabrutinib (Wayrilz); warm AIHA; FDA Breakthrough Therapy; JP orphan • Everest Medicines; VELSIPITY (etrasimod); UC; China NMPA • Priovant Therapeutics; brepocitinib; BEACON; cutaneous sarcoidosis.
References
https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-30-12-00-00-3229451
https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-09-06-00-00-3234232