This weekly update in immunology covers significant developments in the field, including regulatory actions, clinical trial progress, and new collaborations. Key highlights include FDA decisions, approvals, and breakthrough designations.
In Today’s Newsletter
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In Today’s Newsletter
💉 AstraZeneca’s Saphnelo: FDA Complete Response Letter [1] [US • 03 Feb 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/update-on-saphnelo-subcutaneous-administration.html
Context: AstraZeneca received a complete response letter (CRL) for the Biologics License Application (BLA) of Saphnelo (anifrolumab) for subcutaneous administration in systemic lupus erythematosus (SLE).
Key Point: The FDA requested additional information, with a decision expected in the first half of 2026. Intravenous Saphnelo remains available.
Implication: Pending approval, subcutaneous Saphnelo could offer a more convenient treatment option for SLE patients.
💊 AstraZeneca’s Imfinzi: EU Approval for Early Gastric Cancer [2] [EU • 02 Feb 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-recommended-in-eu-for-early-gastric-cancer.html
Context: AstraZeneca’s Imfinzi (durvalumab) recommended for approval by the European Medicines Agency (EMA) for the treatment of early gastric and gastroesophageal junction (GEJ) cancers.
Key Point: The recommendation is based on MATTERHORN Phase III trial results showing significant reductions in disease progression and death risk.
Implication: If approved, this will be the first immunotherapy-based perioperative therapy for these cancers in the EU.
🌍 Sanofi’s Rezurock: EU Approval for Chronic GVHD [3] [EU • Jan 30 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-30-12-00-00-3229451
Context: Rezurock (belumosudil) recommended for approval in the EU to treat chronic GVHD in adults and children aged 12 years and older.
Key Point: Based on data from clinical studies and real-world evidence, Rezurock provides a new treatment option for patients with limited treatment options.
Implication: A potential game-changer for GVHD patients in the EU, addressing unmet medical needs.
🧠 Biogen’s Litifilimab: FDA Breakthrough Therapy Designation [4] [US • Jan 28 2026]
https://investors.biogen.com/news-releases/news-release-details/biogens-litifilimab-receives-fda-breakthrough-therapy
Context: Biogen’s litifilimab has received FDA Breakthrough Therapy Designation for the treatment of cutaneous lupus erythematosus (CLE).
Key Point: Litifilimab, a first-in-class monoclonal antibody, targets BDCA2 and has shown promise in reducing skin disease activity in CLE patients.
Implication: This designation will expedite its development and review, potentially providing a new targeted treatment for CLE.
🧪 Mabtech & Sai Life Sciences: Immunology Research Collaboration [5] [Jan 28, 2026] [US]
https://www.globenewswire.com/news-release/2026/01/28/3227356/0/en/Mabtech-and-Sai-Life-Sciences-Announce-Strategic-Collaboration-to-Advance-Immunology-Research-with-EYRA-Platform-at-Sai-Boston-Site.html
Context: Mabtech and Sai Life Sciences announced a strategic collaboration to advance immunology research using the EYRA platform at Sai’s Boston site.
Key Point: The partnership aims to provide high-sensitivity multiplex cytokine assays and phenotyping services, targeting immuno-oncology, vaccines, and inflammation research.
Implication: This collaboration will accelerate immune profiling for biopharma companies, enhancing research efficiency.
🔬 Repertoire Immune Medicines: Partnership with Lilly [6] [US • Jan 29 2026]
https://www.prnewswire.com/news-releases/repertoire-immune-medicines-announces-strategic-collaboration-with-lilly-to-develop-tolerizing-therapies-for-autoimmune-diseases-302673203.html
Context: Repertoire Immune Medicines has partnered with Lilly to develop tolerizing therapies for autoimmune diseases.
Key Point: The collaboration will leverage Repertoire’s DECODE™ platform to develop targeted therapies aimed at restoring immune balance.
Implication: This partnership signals a new approach to autoimmune disease treatment, potentially offering long-term remission without broad immune suppression.
💉 Galderma: BLA Resubmission for RelabotulinumtoxinA [7] [US • Feb 02 2026]
https://www.dermatologytimes.com/view/fda-accepts-galderma-s-bla-resubmission-for-liquid-neuromodulator-relabotulinumtoxina
Context: Galderma’s relabotulinumtoxinA has received FDA acceptance for resubmission of its BLA.
Key Point: The product offers rapid onset and sustained effects up to six months for wrinkle treatment.
Implication: If approved, relabotulinumtoxinA could disrupt the neuromodulator market with its unique formulation and extended efficacy.
🌱 Arcutis: Phase 2 Data for Roflumilast Cream in Infant AD [8] [Jan 28, 2026] [US]
https://www.dermatologytimes.com/view/phase-2-data-highlight-roflumilast-cream-in-infant-ad
Context: Arcutis presented promising Phase 2 data for roflumilast cream in infants with mild to moderate atopic dermatitis.
Key Point: The cream showed significant improvements in eczema severity, with a favorable safety profile.
Implication: If approved, roflumilast could offer a non-steroidal alternative for treating infant AD, addressing a critical gap in pediatric dermatology.
🔬 Palvella Therapeutics: Statin Use in Porokeratosis [9] [US • 02 Feb 2026]
https://ir.palvellatx.com/news-releases/news-release-details/palvella-therapeutics-announces-scientific-publication-clinical
Context: Palvella published a systematic review of statin use for treating porokeratosis, supporting QTORIN™ pitavastatin development.
Key Point: The review highlights the potential for topical statins to target the mevalonate pathway in treating this rare skin disease.
Implication: QTORIN™ pitavastatin could become a key treatment for disseminated superficial actinic porokeratosis, a condition with no FDA-approved therapies.
Why it matters
- Saphnelo’s subcutaneous administration could offer more convenient treatment for SLE, expanding patient options.
- Imfinzi’s approval would make immunotherapy a viable option in early gastric cancer, advancing treatment standards.
- Rezurock’s potential approval for chronic GVHD would address the critical need for effective therapies in this patient population.
- Litifilimab’s breakthrough designation could pave the way for a novel targeted treatment for CLE, improving patient outcomes.
- The EYRA platform collaboration will enhance immune profiling capabilities, accelerating research and development in immunology.
- Tolerizing therapies from Repertoire and Lilly could redefine autoimmune disease treatment by targeting the root cause without broad immune suppression.
- Galderma’s neuromodulator offers an advanced alternative for facial wrinkle treatment, with rapid and long-lasting results.
- Roflumilast cream for infant AD offers hope for young patients in need of non-steroidal treatments with a strong safety profile.
- QTORIN™ pitavastatin could provide a novel approach to treating porokeratosis, a disease with unmet treatment needs.
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FAQ
What is the status of Saphnelo’s subcutaneous formulation?
Saphnelo’s subcutaneous administration received a complete response letter from the FDA. AstraZeneca is working to address the agency’s concerns, with a decision expected in the first half of 2026. [1]
What is Rezurock and why is it important for GVHD?
Rezurock is a medication for chronic graft-versus-host disease (GVHD), offering a new option for patients with limited treatments. Its approval could address a significant unmet need in GVHD management. [3]
What does the FDA’s Breakthrough Therapy Designation for litifilimab mean?
The FDA granted Breakthrough Therapy Designation to litifilimab for cutaneous lupus erythematosus (CLE), which will expedite its development and review, potentially providing a new targeted treatment for CLE. [4]
Why is the EYRA platform significant for immunology research?
The EYRA platform allows for high-sensitivity multiplex immunology assays, accelerating the development of therapies in immuno-oncology, inflammation, and other immune-related diseases. [5]
Entities / Keywords
Saphnelo (AstraZeneca) • Systemic lupus erythematosus • Imfinzi (AstraZeneca) • Gastric cancer • Rezurock (Sanofi) • Graft-versus-host disease • Litifilimab (Biogen) • Cutaneous lupus erythematosus • EYRA (Mabtech) • Immunology • Tolerizing therapies (Repertoire Immune Medicines) • RelabotulinumtoxinA (Galderma) • Atopic dermatitis • Roflumilast (Arcutis) • Porokeratosis • QTORIN™ (Palvella Therapeutics).
References
- https://www.astrazeneca.com/media-centre/press-releases/2026/update-on-saphnelo-subcutaneous-administration.html
- https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-recommended-in-eu-for-early-gastric-cancer.html
- https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-30-12-00-00-3229451
- https://investors.biogen.com/news-releases/news-release-details/biogens-litifilimab-receives-fda-breakthrough-therapy
- https://www.globenewswire.com/news-release/2026/01/28/3227356/0/en/Mabtech-and-Sai-Life-Sciences-Announce-Strategic-Collaboration-to-Advance-Immunology-Research-with-EYRA-Platform-at-Sai-Boston-Site.html
- https://www.prnewswire.com/news-releases/repertoire-immune-medicines-announces-strategic-collaboration-with-lilly-to-develop-tolerizing-therapies-for-autoimmune-diseases-302673203.html
- https://www.dermatologytimes.com/view/fda-accepts-galderma-s-bla-resubmission-for-liquid-neuromodulator-relabotulinumtoxina
- https://www.dermatologytimes.com/view/phase-2-data-highlight-roflumilast-cream-in-infant-ad
- https://ir.palvellatx.com/news-releases/news-release-details/palvella-therapeutics-announces-scientific-publication-clinical