Feb. 28 Quick Takes: Heidelberg shares jump as Huadong takes stake
Plus FDA approves CTI’s pacritinib, Aurinia shares sink, Lexicon submission delayed, priority review for neoadjuvant Opdivo and more
Huadong Medicine Co. Ltd. (SZSE:0963) will become the second-largest shareholder in oncology biotech Heidelberg Pharma AG (Xetra:HPHA) as part of a partnership in which the China-based company will gain rights in Asia to at least two antibody-drug candidates. The deal includes local, ex-Japan rights to HDP-101, which targets BCMA and became Heidelberg’s first clinical program this month; and HDP-103, which targets PSMA. Both use Heidelberg’s ATAC platform. Huadong will also gain options to a program targeting CD37 and another with an undisclosed target. Heidelberg will receive $20 million up front and is eligible for $910 million in milestones, plus royalties; Huadong will receive a 35% stake as part of a rights issue and share transfer. Germany-based family investment vehicle dievini Hopp will remain Heidelberg’s largest shareholder. The biotech gained 53% on the news.
CTI BioPharma Corp. (NASDAQ:CTIC) said FDA granted accelerated approval to its kinase inhibitor Vonjo pacritinib to treat adults with intermediate or high-risk myelofibrosis with a platelet count below 50 × 109/L. According to the company, it is the first therapy approved specifically for cytopenic myelofibrosis patients. In the Phase III PERSIST-2 trial, 29% of patients in the treatment arm had a reduction in spleen volume of at least 35% vs. 3% of patients receiving best available therapy. The company, which expects results from the confirmatory PACIFICA trial in mid-2025, said it will launch the therapy in 10 days, funded in part by a $60 million infusion from DRI Healthcare Trust. Under a previous debt and royalty transaction, FDA approval of Vonjo triggered the acquisition by DRI of a tiered royalty for Vonjo...