SAN FRANCISCO, Calif. — Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study...
treatment News
SHANGHAI, China — YolTech Therapeutics announced that the first patient has been dosed with YOLT-101, the company’s in vivo genome editing candidate being developed as a single dose, potentially curative therapy for Familial Hypercholesterolemia(FH), marking the commencement of an Investigator-Initiated Trial (IIT). Familial Hypercholesterolemia (FH) is a genetic disorder that...
SHANGHAI, China — YolTech Therapeutics, a late clinical-stage biotechnology company developing in vivo gene editing therapies, today announced positive interim data from an investigator-initiated trial (IIT) of YOLT-202, the Company’s investigational in vivo base editing therapy, for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) that demonstrated positive safety and tolerability as well...
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)...
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...
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...
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...