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.
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Copenhagen, Denmark – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for Zeydovio™ (glepaglutide), a long-acting, next-generation...
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...
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 that safety and efficacy outcomes from the Phase 3 INDIGO...
CALGARY, Alberta – Zenith Epigenetic Ltd. (“Zenith” or the “Company”) today held its annual general meeting of shareholders (“AGM”), during which President & CEO Donald McCaffrey provided an update to investors on ZEN-3694’s clinical development program for the treatment of NUT carcinoma. Highlights from the presentation are summarized below and...
LEXINGTON, Mass. — Partner Therapeutics, Inc. (PTx), a privately held, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zenocutuzumab‑zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. Zenocutuzumab-zbco is being developed in a subset...
BOSTON, Mass. — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on bringing life-changing therapeutics to people living with rare diseases, today announced the publication of “Long-term real-world safety and effectiveness of arimoclomol in individuals with NPC: Outcomes from the US Early Access Program over...
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...