FDA Crushes SteadyMed With Refusal to File Letter

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SteadyMed Ltd. (NASDAQ: STDY) shares plummeted after the news that it had received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA). This is yet another company that the FDA has single-handedly crushed this week, but not without a good reason.

The RTF is in regards to the firm’s New Drug Application (NDA) for Trevyent in the treatment of pulmonary arterial hypertension (PAH).

Based on a preliminary review of the NDA, submitted in June 2017, the FDA decided that the application is not sufficiently complete to permit a substantive review.

The FDA has requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product.

Looking ahead, within the next 30 days, SteadyMed will request a Type A meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA. The firm will provide further guidance after the anticipated meeting with FDA.

Jonathan M. N. Rigby, President and CEO of SteadyMed, commented:

We believe that the issues raised in the letter from FDA can be sufficiently addressed. Our next step is to work with the FDA to address the open issues and identify a path to a successful resubmission and acceptance of our application. We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and remain committed to bringing the product to patients in need.

Shares of SteadyMed were last seen down about 43% at $3.37, with a consensus analyst price target of $16.00 and a 52-week range of $2.25 to $9.70.