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Tag: autoimmune

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven...

Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as...

HkeyBio Launches “NHP Fast-PoC” Program to Deliver Low-Cost Cyno PK/PD and Developability Data Amid Rising NHP Prices

The cost-effective platform delivers rapid pharmacological validation data in cynomolgus monkeys, helping biotech firms make confident R&D decisions before committing to full-scale IND studies.BOSTON...

Immunic to Participate in Investor, Industry and Scientific Conferences in June

NEW YORK, June 10, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases,...

Antengene Receives IND Approval for ATG-201 (CD19 × CD3 TCE) in Autoimmune Disease in China

SHANGHAI and HONG KONG, June 10, 2026 /PRNewswire/ -- Antengene Corporation Limited  ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to...

Lynk Pharmaceuticals’ Partner Formation Bio Doses First Participant in Phase 1 Trial of BLKR201 (originally designated as LNK01006), a CNS-Penetrant TYK2 Inhibitor

HANGZHOU, China, SHANGHAI and BOSTON, June 10, 2026 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on...

Selagine Plasma to Advance Pooled Plasma Eye Drops for Moderate-to-Severe Dry Eye

Agreement with Selagine, Inc. supports the development of an investigational pooled plasma biologic platform intended to move beyond individualized compounded serum tearsCHICAGO, June 9,...

Everest Medicines Enters into Exclusive Asia-Pacific Licensing Agreement with Vcare PharmaTech for Sumecigrel

SHANGHAI, June 9, 2026 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing,...

Ascendis to Showcase Advances in Treatment of Rare Endocrine Diseases at ENDO 2026

COPENHAGEN, Denmark, June 08, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the latest data from its Endocrinology Rare Disease programs in hypoparathyroidism, achondroplasia, and pediatric growth hormone deficiency will be shared in two oral presentations and three posters at ENDO 2026, the annual meeting of the Endocrine Society being held in Chicago from June 13-16, 2026.

Artiva Biotherapeutics Highlights AlloNK® Data Presented at EULAR 2026, FDA RMAT Designation in Refractory Rheumatoid Arthritis and Webcast Today

Artiva Biotherapeutics Highlights AlloNK® Data Presented at EULAR 2026, FDA RMAT Designation in Refractory Rheumatoid Arthritis and Webcast Today

Kali Therapeutics Announces Poster Presentation of KT209, a Novel CD19 x CD20 x CD3 Trispecific Antibody, at the EHA 2026 Annual Congress

SAN MATEO, Calif., June 8, 2026 /PRNewswire/ -- Kali Therapeutics, a clinical-stage biotechnology company pioneering next-generation immune-resetting and multi-specific therapies, today announced that preclinical...

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

Novartis to highlight Rhapsido® data across multiple immune-mediated diseases at EAACI Congress 2026

Basel, June 8th, 2026 – Novartis will present data from 10 abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, spanning Rhapsido®  (remibrutinib) clinical trial results and real-world evidence on patient burden and treatment experience. Highlights include two late-breaking oral presentations; the Phase III RemIND trial for Rhapsido in chronic inducible urticaria (CIndU) and extension data from the Phase IIIb REMIXED trial in chronic spontaneous urticaria (CSU).

“The Rhapsido presentations at EAACI 2026 expand our understanding of BTK inhibition across multiple immune-mediated diseases and provide evidence of its potential to make a meaningful impact for patients who continue to face significant burden and limited treatment options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “Novartis will present Rhapsido data from a long-term extension trial in chronic spontaneous urticaria, Phase III data in three types of chronic inducible urticaria, and early Phase II dose-response analysis for food allergy – together providing scientific evidence for its impact across numerous diseases.”

Abstracts accepted by EAACI include: 

LENZ Therapeutics Announces Everest Medicines Acquired Rights to Develop and Commercialize VIZZ® (LNZ100) in Greater China

The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027
The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027

Cullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 Congress

Clinical benefit, including remissions, demonstrated in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients following a single target dose of CLN-978 

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