Shares in SteadyMed (NSDQ:STDY) rose 6% today after the company said it inked a $30 million private placement with Adage Capital Management, OrbiMed, Deerfield Management and Kingon Capital Management.
The San Ramon, Calif.-based company plans to use its newly-acquired funds to prepare for the commercial launch of its pulmonary arterial hypertension treatment, Trevyent. The therapy is a combination of treprostinil and the PatchPump prefilled, disposable infusion system.
“We recently achieved several significant milestones, having received a favorable ruling by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office in our inter partes review that invalidated all of the claims in the United Therapeutics’ ‘393 patent and completed the clinical validation study of our lead drug product candidate Trevyent, that is in development to treat pulmonary arterial hypertension,” president & CEO Jonathan Rigby said in prepared remarks. “We are on track to submit our NDA for Trevyent in this calendar quarter and continue executing on our pre-commercialization strategy, leading to the launch of Trevyent in the U.S. in 2018, if approved by the FDA. We are delighted with the strong support of our existing investors and pleased to have several new, high quality institutional healthcare funds that support our belief that Trevyent has the potential to capture substantial share of the PAH market.”
STDY shares were trading at $6.25 apiece in mid-morning activity today, up 4.2%.
At the start of April, SteadyMed finished a clinical study for Trevyent and said it is on track to submit a New Drug Application for its lead drug candidate in the 2nd quarter of 2017.
The trial enrolled 60 healthy adults and each participant was given 1 PatchPump device with a placebo formulation to be used for 48 hours. The study’s objective was to evaluate safety and performance functions of Trevyent’s delivery system, including dose accuracy, precision, and tolerability for on-body application, the company said.
SteadyMed reported that the PatchPump devices performed “as intended in all categories of evaluation.”
