SteadyMed Ltd. (NASDAQ: STDY) shares made an incredibly gain to close out the week, after a positive meeting with the U.S. Food and Drug Administration (FDA). Specifically, the firm said that it has received final minutes from the FDA on the work necessary to resubmit its New Drug Application (NDA) for Trevyent for the treatment of pulmonary arterial hypertension (PAH).
This could be the turnaround that SteadyMed needs. The stock is down about 55% in just the past six months alone, excluding Friday’s move. Despite this drop off, the stock is actually still positive in 2017, posting a gain of 19%.
As we have said before about the FDA, this agency has the potential to make or break companies. And in this case, SteadyMed seems to be getting a second wind.
Essentially, the FDA is not requiring SteadyMed to conduct any clinical trials to prove the safety or efficacy of Trevyent and has agreed that a repeat of in-vitro design verification testing on the final to-be-marketed Trevyent product, supported by pharmacokinetic modelling and process validation, should be adequate for the resubmission and acceptance of the NDA.
SteadyMed expects both NDA submission and acceptance to occur before the end of 2018. SteadyMed ended the third quarter of 2017 with a cash position of $37.4 million, which management believes will provide more than sufficient capital to fund operations through the NDA resubmission and acceptance.
Jonathan M. N. Rigby, president and CEO of SteadyMed, commented:
We are very pleased with the outcome of our meeting with FDA, we have clarity on the work that needs to be done and are confident that our agreed path forward will lead to a resubmission and acceptance for filing of the Trevyent NDA. We continue to strongly believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and we remain committed to bringing the product to patients in need.
Shares of SteadyMed were up about 33% at $4.00 early Friday, with a consensus analyst price target of $16.00 and a 52-week range of $2.25 to $9.70.