Antibody-drug conjugate developer Duality Biotherapeutics Inc. debuted on the Hong Kong Stock Exchange (HKEX) with a HK$1.64 billion (US$211.4 million) IPO April 15, making it one of the biggest offerings made under the HKEX’s Chapter 18A listing regime since 2020.
In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. “My first term included numerous significant actions, including some of the most aggressive in recent history, to deliver lower prescription drug prices to American patients,” Trump noted in the order, which builds on many of those actions, including increased competition, re-importation, price transparency and a mandate to pass discounts through to patients.
Genes associated with lysosomal dysfunction increase the risk of Parkinson’s disease (PD), according to a study led by scientists at Northwestern University. The discovery also explains why some people who carry a pathogenic variant of the GBA1 gene develop PD or dementia with Lewy bodies (DLB) and others do not. The key lies in the Commander complex, involved in the transport of proteins to this organelle. This discovery raises the need for combinatorial therapies that act on more than one pathway for this type of neurodegenerative disorder.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Cellenkos, Fate, Genentech, Ironwood, Mirum, Roche, Synox.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accord, Amgen, Coherus, Intas, Kinnate, Sandoz, Sumitomo, Third Harmonic, Xoma Royalty.
Phase I/II trial results of sacituzumab tirumotecan (sac-TMT; Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.) published in Nature Medicine came a month after China’s National Medical Products Administration gave clearance to Kelun-Biotech’s supplemental NDA of sac-TMT to treat advanced non-small-cell lung cancer (NSCLC).
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met primary and secondary endpoints in the Symphony 1 and Symphony 2 phase III trials in type 2 diabetes in Chinese patients. Based on the data, Shenzhen-based Hightide will submit an NDA to China’s National Medical Products Administration (NMPA) later this year.