A promising but side effect-ridden phase III study by Novartis AG with oral imatinib in pulmonary arterial hypertension (PAH) led Boston-based Aerovate Therapeutics Inc. to start exploring two years ago an aerosol form of the kinase inhibitor, and the project has won backing to the tune of $72.6 million in series A money.
HONG KONG – Tokyo-based Daiichi Sankyo Co. Ltd. has hit its goals in a phase III study testing the use of prasugrel hydrochloride in thrombotic stroke patients.
Since the stock-jolting phase III blowup in March of Milestone Pharmaceuticals Inc.’s etripamil for paroxysmal supraventricular tachycardia (PSVT), questions have lingered regarding the short-acting channel blocker’s regulatory path forward – but no longer. Shares of Montreal-based Milestone (NASDAQ:MIST), which in the spring plummeted to an all-time low of $1.70, made up for the loss and then some, closing at $8.91, up $5.57, or 167%, on word that the FDA has agreed to terms whereby an NDA for the nasal spray may be submitted without launching another phase III study.
Fulcrum Therapeutics Inc. and Myokardia Inc. agreed to discover, develop and commercialize therapies for treating genetic cardiomyopathies, a deal spun out of two companies with a mutual appreciation of each other’s abilities as well as personal relations and networking, Fulcrum’s CEO told BioWorld.
Cytokinetics Inc.’s new deal with RTW Investments gives the company a new presence in Asia and a strong influx of cash that should last at least two or three years.
Shares of Kiniksa Pharmaceuticals Ltd. hit a 52-week high on June 29 as pivotal phase III results showed that Arcalyst (rilonacept), a medicine it licensed from Regeneron Pharmaceuticals Inc., led to a 96% reduction in risk of recurrent pericarditis events among 61 people not helped by standard-of-care treatments.
HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals.
Levosimendan's long story took a new turn with results from a phase II trial testing chronic administration of the calcium sensitizer in patients with pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF).
The phase III pivotal trial of mavacamten, an oral, allosteric cardiac myosin modulator for treating symptomatic, obstructive hypertrophic cardiomyopathy, from Myokardia Inc., of Brisbane, Calif., hit its primary and all of its secondary endpoints.
With new a FDA approval for a years-old type 2 diabetes drug, Astrazeneca plc's Farxiga (dapagliflozin) has become the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure patients with reduced ejection fraction, a measure of how much blood the left ventricle pumps out with each contraction.
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