The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.
Shares of Bellerophon Therapeutics Inc. (NASDAQ:BLPH), rescued from potential delisting by a recent reverse stock split, shot 168.4% higher to $9.20 on Feb. 18 as new top-line data from a small phase II study showed its inhaled nitric oxide delivery system, Inopulse, delivered significant improvements in blood flow for people with pulmonary hypertension (PH) associated with pulmonary fibrosis (PF).
Shares of Bridgewater, N.J.-based Insmed Inc. (NASDAQ:INSM) closed at $28.88, up $8.34, or 40.6%, on positive top-line results from the global, randomized, double-blind placebo-controlled phase II study called Willow, testing INS-1007 once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE).
Vertex Pharmaceuticals Inc. brought in $4.16 billion in product revenues in 2019, bolstered in large part by the late October approval of Trikafta, earning $420 million in the few weeks that remained in the year.