Regenerative medicine company Mesoblast Ltd. plans to raise AU$97 million (US$64.5 million) to conduct additional phase III registration trials for its allogeneic stem cell treatment for steroid-refractory acute graft-vs.-host disease and for chronic back pain, as required by the U.S. FDA.
Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news.
A new deal between privately held Hummingbird Bioscience Pte. Ltd. and Endeavor Biomedicines Inc. is just one of three antibody-drug conjugate (ADC) agreements reached in the past week, marking a fourth-quarter surge for the therapy.
Qyuns Therapeutics Co. Ltd. has filed to list on the Hong Kong Exchange to fund its autoimmune and allergic disease therapy pipeline, including lead assets QX-002N for ankylosing spondylitis and QX-005N for multiple indications including atopic dermatitis.
Everest Medicines Ltd. is in-licensing Kezar Life Sciences Inc.’s phase II autoimmune disease candidate, zetomipzomib in a deal worth $132 million for greater China, South Korea and southeast Asia rights. Kezar’s lead molecule zetomipzomib (KZR-616) is a first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases.
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
Worg Pharmaceuticals (Zhejiang) Co. Ltd. raised ¥1.1 billion (US$152 million) in a series C round to develop its therapies for allergy and autoimmune diseases, as well as to expand into the global market.
Lynk Pharmaceuticals Co. Ltd. raised ¥200 million (US$28 million) in a series C1 financing round to accelerate the clinical development of its second-generation and third-generation JAK inhibitors for cancer and autoimmune diseases.
Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T.
Daewoong Pharmaceutical Co. Ltd. has out-licensed its phase I-ready autoimmune disease candidate, DWP-213388, to new spinout company Vitalli Bio in a deal worth up to $477 million.
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