Tag: Pivotal

NEW YORK, June 09, 2026 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to lasmecabtagene timgedleucel (lasme-cel), its CD22-targeting allogeneic CAR-T cell therapy product candidate, for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).

ZUG, Switzerland, June 08, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company focused on innovations addressing neuro-ophthalmic and ophthalmic diseases with significant unmet medical needs, announced today that Oculis’ management will participate in a fireside chat at the 47^th Annual Goldman Sachs Global Healthcare Conference.  

CALGARY, Alberta, June 08, 2026 (GLOBE NEWSWIRE) -- Reconnaissance Energy Africa Ltd. (the “Company” or “ReconAfrica”) (TSXV: RECO) (OTCQX: RECAF) (Frankfurt: 0XD) (NSX: REC), along with partners NAMCOR and BW Energy, have commenced production testing operations at Kavango West 1X (“KW1X”).

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.

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: