Tag: file

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.

Company Announcement No 47/2026  

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: 

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

$8.5 million upfront with up to approximately $15.2 million of potential additional gross proceeds upon the exercise in full of warrants

MONTREAL, June 05, 2026 (GLOBE NEWSWIRE) -- PREMIER HEALTH OF AMERICA INC. (TSX-V: PHA) (“Premier Health”, or the “Company”) announces that, further to its press release dated June 2, 2026, the Autorité des marchés financiers, as the Company’s principal regulator, has granted a management cease trade order (the “MCTO”) under National Policy 12-203 – Management Cease Trade Orders.

Gross Profit Increased 17% Year-Over-Year to $7.0 Million in 2025