SteadyMed Therapeutics

About SteadyMed Therapeutics

SteadyMed Therapeutics, founded in 2005 by Ian Solomon, Amir Genosar, and Gideon Kahana, was a specialty pharmaceutical company focused on developing treatments for orphan and high-value diseases. The company began its journey in the Rad Biomed incubator in Israel. The business centered on creating drug-device combination products to address unmet needs for parenteral drug delivery.

The company's lead product candidate was Trevyent, a combination of the drug treprostinil and the proprietary PatchPump delivery system. This product was designed for the subcutaneous treatment of pulmonary arterial hypertension (PAH), a rare and serious condition characterized by high blood pressure in the lungs. The PatchPump technology was a single-use, wearable, and disposable device, pre-filled with the drug and pre-programmed for administration over two days. This design intended to simplify treatment for PAH patients by removing the need for cumbersome daily drug preparation and pump programming that was common with existing therapies.

Under the leadership of President and CEO Jonathan M.N. Rigby, who brought decades of experience from roles at companies like Merck and Bristol Myers Squibb, SteadyMed progressed its lead candidate. The company went public with an IPO on NASDAQ in March 2015. A significant milestone in the company's history was its acquisition by United Therapeutics in August 2018 for a total potential value of $216 million. This deal followed a period where SteadyMed faced regulatory hurdles, including a Refusal to File letter from the FDA for Trevyent in 2017 due to requests for more data on the device. Ultimately, in 2021, United Therapeutics ceased the development of Trevyent, citing the need for a significant product redesign and further clinical studies which were deemed not commercially reasonable.