Pulmonary arterial hypertension (PAH) is a progressive disorder where high pulmonary artery pressure and vascular resistance lead to progressive dyspnea, and right ventricular hypertrophy (RVH).
Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
Despite the U.S. FDA’s tentative approval of Liquidia Corp.’s Yutrepia (treprostinil) for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, the company is stuck in the starting gate. Liquidia said it disagrees with the agency’s stance of simultaneously granting regulatory exclusivity in both indications to United Therapeutics Corp.’s powdered formulation of treprostinil, branded Tyvaso, until May 23, 2025. That means full approval for the inhalation powder won’t come until after that date and neither will a Yutrepia launch.
Aerovate Therapeutics Inc. is shutting down the ongoing phase III portion of its Impahct study of AV-101, an inhaled version of PDGFR inhibitor imatinib, after reporting top-line data from the phase IIb portion failed to meet primary and secondary endpoints in patients with pulmonary arterial hypertension (PAH). It was a major blow for the single-product company, sending shares (NASDAQ:AVTE) falling 93% to close June 17 at $1.65, down $22.97.
Actelion Pharmaceuticals Ltd. has identified pyrazolopyrrolopyridazines acting as platelet-derived growth factor receptor β (PDGFR-β, PDGFRB) inhibitors reported to be useful for the treatment of pulmonary arterial hypertension.
Gyre Therapeutics Inc. has announced IND clearance for Gyre Pharmaceuticals’ F-230 tablets by China’s National Medical Products Administration (NMPA). F-230 is a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH).
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.
A team at the Institute of Cellular Biology and Pathology ‘Nicolae Simionescu’ of Romanian Academy aimed to assess the effects of targeted siRNA for AP-1 silencing on restoring structural...
Pulmonary arterial hypertension (PAH) is a severe condition characterized by vasoconstriction and remodeling of the small pulmonary arteries, driven by a complement-dependent activation of macrophages, for which an effective treatment is lacking. Chinese researchers have investigated the potential of a complement C3 inhibitor polypeptide, CP40-KK, as an approach for treating PAH. To do this, they used a model in which PAH was induced in rats by monocrotaline.
