SteadyMed Stock Price Declines Following FDA Refusal Letter

SteadyMed (NASDAQ:STDY) suffered an extensive decline in its stock on Thursday (August 31), thanks to a refusal from the US Food and Drug Administration (FDA).
The regulatory agency denied SteadyMed’s new drug application for Trevyent, a single-use pump of treprostinil for the treatment of Pulmonary Arterial Hypertension.
Jonathan Rigby, president, and CEO of SteadyMed said they will be able to correct the mistakes of this initial application. “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,” Rigby said.
SteadyMed applied for this NDA only in June of this year, however based on a preliminary review, the FDA found the application wasn’t “sufficiently complete to permit a substantive review.”

SteadyMed suffers over 30 percent decline

SteadyMed’s share price was a little shaky on Thursday, dropping 33.90 percent to close at $3.90.
Based on reporting from BioPharma DIVE, this is the second refusal letter the FDA sent this week, a move that may indicate “continued attempts to optimize the drug approval process, in part through rejecting would-be products earlier in the regulatory pathway.” This is a way to save time and money from both sides of the approval process.
The other denial was in response to Acorda Therapuetics’ (NASDAQ:ACOR) Parkinson’s disease candidate. The reply from the FDA sent their stock down 22.66 percent to close on Tuesday, August 29, at $19.45. Since then Acorda has slowly begun to build some of its lost momentum back and is currently valued again over $20.
Last week the FDA also sent Cardiome Pharma (NASDAQ:CRME; TSX:COM) back to the drawing board based on the resubmission of their NDA for Brinavess, a corrective treatment for an arrhythmic heartbeat.

Investor Takeaway

This move by the FDA while seemingly coincidental should prove to be a warning for companies with aspirations of approval to submit qualified candidates only and make sure to backup their data all the way through. Otherwise, the results in their trading can prove to be significant.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.