With a $128 million series A financing, Diagonal Therapeutics Inc. launched to develop its lead program using agonist antibodies for treating, among other indications, the rare disease hereditary hemorrhagic telangiectasia. The antibodies are designed to activate a receptor complex in the TGF-β superfamily genetically impaired in patients with the bleeding disorder. Diagonal also is developing a treatment for the orphan disease pulmonary arterial hypertension.
Merck & Co. Inc. is looking to a fast launch for sotatercept, its newly U.S. FDA-approved pulmonary arterial hypertension (PAH) drug. The agency cleared the drug, branded Winrevair, under priority review on its March 26 PDUFA date, marking the first in a new class of therapies the company has touted for its potential for disease modification.
In what co-founder and CEO Claudia Ulbrich called the “right decision with right partner at the right point in time,” Cardior Pharmaceuticals GmbH agreed to an acquisition by Novo Nordisk A/S in a deal worth up to €1.025 billion (US$1.1 billion) that puts a potentially disease-modifying heart failure candidate in the hands of a big pharma player in the midst of establishing its presence in cardiovascular disease.
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.
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