Cologne, Germany – Zanubrutinib, a second-generation Bruton tyrosine kinase (BTK) inhibitor, is approved for several therapeutic indications. The German Institute for Quality and Efficiency in Health Care (IQWiG) investigated whether the drug has an added benefit compared with the appropriate comparator therapy for adult patients with chronic lymphocytic leukaemia (CLL)...
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DUARTE, California – The novel drug, zanzalintinib (XL092), showed promising cancer-fighting abilities in patients with advanced clear-cell renal cell carcinoma (ccRCC), according to initial results from the STELLAR-001 clinical trial. According to trial results, which were presented at the 2023 International Kidney Cancer Symposium, antitumor activity was observed in patients...
Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced financial results for the 12-month period from January 1 to December 31, 2022 and provided a corporate update.
COPENHAGEN, Denmark – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult...
Copenhagen, Denmark – The FDA rejected Zealand Pharma’s glucagon receptor agonist in congenital hyperinsulinism (CHI) after identifying problems at a third-party manufacturing site. The company said it remains confident that it can resubmit in the first half of 2024. Zealand revealed last week that the regulator issued a complete response...
WALTHAM, Mass. — Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced positive results from the Phase 2 MoonStone trial of obexelimab...
CELEBRATION, Fla. — Zevra Therapeutics Inc., a rare disease therapeutics company, today announced it resubmitted its New Drug Application (NDA) for arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC) to the U.S. Food and Drug Administration (FDA) on December 22, 2023. Based on standard...
CELEBRATION, Fla. — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced the presentation of several posters highlighting new positive data on MIPLYFFA® (MY-PLY-FAH) (arimoclomol) for the treatment of Niemann-Pick disease type C (NPC) at the International...
CELEBRATION, Fla. — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, announced the publication of “Long-term Efficacy and Safety of Arimoclomol in Niemann-Pick Disease Type C: Final Results of the Phase 2/3 NPC-002 48-month Open-label Extension...
CELEBRATION, Fla. — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare diseases, announced the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the evaluation of arimoclomol for the treatment of Niemann-Pick...