SAN RAMON, Calif, – SteadyMed Ltd. (Nasdaq: STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced that it has entered into definitive agreements to sell
shares of its common stock and warrants to purchase shares of its common stock for aggregate gross proceeds of up to approximately $32 million in a two-tranche private placement. The financing was led by new investor OrbiMed with participation from existing investors including, Federated Investors, Inc.
and Deerfield Management.
“This financing is exciting news for our Company, strengthens our balance sheet and enables us to execute on our development and pre-commercialization plans for our lead product candidate Trevyent® for the treatment of Pulmonary Arterial Hypertension (PAH),” said Jonathan Rigby, President & CEO of
SteadyMed. “We remain on track with our overall goal of a commercial launch of Trevyent in the U.S. in late 2017. We are focused on our New Drug Application (NDA) for Trevyent, which we expect to submit to the Food and Drug Administration (FDA) in Q1 2017, and plan to deprioritize our At Home Patient
Analgesia Products to allow for this.”
“We believe SteadyMed is well positioned for regulatory and commercial success based on our positive conversations with the FDA, the institution of our Inter Partes Review (IPR) by the US Patent and Trademarks Office (USPTO) against a patent held by United Therapeutics (Nasdaq: UTHR), and Trevyent’s orphan drug designation, which we believe would provide us with 7 years of market exclusivity. We look forward to the opportunity to bring to market a much needed improvement in the treatment of PAH, and appreciate the confidence in SteadyMed that has been demonstrated by our existing and new investors.”
JMP Securities served as lead placement agent for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann acted as co-placement agents in the transaction.
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