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...
treatment News
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...
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, today announced the presentation of four posters highlighting positive new data on MIPLYFFA® (arimoclomol) for the treatment of Niemann-Pick Disease Type C (NPC) at the 22nd Annual...
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 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion regarding...
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...