SteadyMed (NASDAQ: STDY) shares are down 35% this morning after the company said it has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for Trevyent®. The Trevyent NDA was submitted in June 2017 for the treatment of Pulmonary Arterial Hypertension (PAH). Upon preliminary review of the NDA, the FDA determined that it was not adequately complete to permit a substantive review. The FDA has requested more details regarding certain device specifications and performance testing. The FDA also requested further design verification and validation testing on the final, to-be-marketed Trevyent product. The company intends to request a Type A meeting with the FDA within the next 30 days to gain clarification for resubmission. “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,” SteadyMed president and CEO Jonathan M. N. Rigby stated in the news release.
To view the full press release, visit: http://nnw.fm/5rkbY
About SteadyMed
SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. SteadyMed intends to commercialize Trevyent in the U.S. and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada and the Middle East. SteadyMed has offices in San Ramon, California and Rehovot, Israel. For additional information about SteadyMed please visit www.steadymed.com.
More from NetworkNewsBreaks
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
For more information please visit https://www.networknewswire.com
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
NetworkNewsWire (NNW)
New York, New York
www.networknewswire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
