About six months after Johnson & Johnson (J&J) returned rights to the compound, oral Tryvio (aprocitentan) won FDA clearance for Idorsia Ltd. Given once daily at a 12.5 mg dose, Tryvio is indicated for hypertension in combination with other blood pressure drugs in patients whose condition is not adequately controlled.
Silence Therapeutics plc disclosed positive top-line 36-week data from the Alpacar-360 phase II study with zerlasiran, a short interfering RNA gene muter that targets lipoprotein(a), but also said Mallinckrodt plc has quit development of a separate prospect.
China’s Pegbio Co. Ltd. is planning a Hong Kong IPO to advance PB-119, its main glucagon-like peptide 1 receptor agonist for diabetes nearing domestic approval, as it hopes to transition to an operating profit.
Wegovy (semaglutide) has racked up another indication. The U.S. FDA approved the injectable for reducing risk of major adverse cardiovascular events such as death, heart attack or stroke and for long-term weight management. The approval expands the drug’s potential. The mighty glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S was already approved for those age 12 and older who are obese and for some overweight adults with weight-related problems.
The RNAi therapeutic zilebesiran, which was the focus of a 2023 $2.8 billion deal between Alnylam Pharmaceuticals Inc. and Roche Holding AG, demonstrated significant systolic blood pressure reductions in patients with mild to moderate hypertension who were part of the Kardia-2 phase II study.
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial.
OSE Immunotherapeutics SA disclosed a $713 million deal with Abbvie Inc. for preclinical-stage monoclonal antibody OSE-230, a potentially first-in-class therapy for treating a range of inflammatory diseases, while Idorsia Ltd. found a partner for two phase III-stage assets in Viatris Inc., as dealmaking continues strong in 2024.
Alnylam Pharmaceuticals Inc.’s decision to change its analysis plan for the phase III Helios-B trial of RNAi therapeutic Amvuttra (vutrisiran) to treat transthyretin amyloidosis with cardiomyopathy, pushing top-line results back by three months, pressured its share price (NASDAQ:ALNY) down by 10% on Feb. 15, while also boosting shares of competitor Bridgebio Pharma Inc. (NASDAQ:BBIO) by 14%.
CSL Ltd. will review the data further to see if there is a path forward for CSL-112 (human apolipoprotein A-I) after the phase III AEGIS-II trial failed to meet the primary efficacy endpoint in reducing the risk of major adverse cardiovascular events in patients following an acute heart attack.
Armed with strong phase III safety data in Japanese patients, Palo Alto, Calif.-based Bridgebio Pharma Inc. is planning to file for Japan approval of its investigational drug acoramidis for a rare heart disorder.
RSS
