As Acceleron Pharma Inc.’s phase II trial of sotatercept hit its primary endpoint and some key secondary endpoints in significantly reducing pulmonary vascular resistance, the stock (NASDAQ:XLRN) reacted accordingly, gaining 50% on Jan. 28. The stock ended the day at $79.39, up $26.52. The Cambridge, Mass.-based company’s candidate is a fusion protein aimed at pulmonary arterial hypertension (PAH). The phase II PULSAR trial’s top-line data, taken from patients who were also on PAH-specific therapies, showed sotatercept achieving a statically significant reduction in pulmonary vascular resistance, which was the study’s primary endpoint, at week 24 vs. placebo. More than half the patients were on three or more therapies during the study.
The pending Abbvie Inc. merger with Allergan plc, expected to close in the first quarter, brought good tidings to another “A” company on Monday, allowing Astrazeneca plc to regain global rights to its late-stage Crohn’s disease and ulcerative colitis (UC) drug, brazikumab, an anti-IL-23 therapy that was out-licensed to Allergan in a $1.27 billion deal in 2016.
Novo Nordisk A/S' Ozempic, a once-weekly injectable version of the company's glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide, first FDA-approved in late 2017, has won the agency' approval for a new indication: reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) and known heart disease.
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
DUBLIN – Compared to other indication areas, gene therapy for cardiac disease is still at the “caveman” stage, according to Dinaqor AG CEO and Chairman Johannes Holzmeister. The Pfäffikon, Switzerland-based firm aims to drag it into the modern era by applying a novel locoregional delivery system to its adeno-associated virus 9 (AAV9) vector technology.
Little more than a month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously supported approval of Amarin Corp. plc's fish oil-based Vascepa (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adults with elevated triglyceride levels, the agency has greenlighted a label expansion for the already-approved medicine, allowing for its adjunctive use in that indication.
Vancouver, British Columbia-based Correvio Pharma Corp. is hoping that it will receive a positive response from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, which meets tomorrow to consider the U.S. approvability of Brinavess (vernakalant hydrochloride, I.V.), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).
BEIJING – Tokyo-based biotech firm Heartseed Inc., which focuses on regenerative medicine, has closed a series B financing round to pocket $26 million that will go to its lead drug candidate, HS-001, for treating heart failure.
DUBLIN – 4Teen4 Pharmaceuticals GmbH raised €6.9 million (US$7.7 million) in a series A round to take procizumab, a first-in-class inhibitor of circulating dipeptidyl-peptidase 3 (cDPP3), into clinical trials for patients with cardiogenic shock.
Stem cell biotech firm Novoheart Holdings Inc., of Vancouver, British Columbia, is partnering with Astrazeneca plc, of Cambridge, U.K., to co-develop a human-specific in vitro, functional model of heart failure with preserved ejection fraction.